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Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03004469
Recruitment Status : Completed
First Posted : December 28, 2016
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Polichem S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alopecia, Androgenetic
Interventions Drug: P-3074
Drug: Finasteride
Drug: P-3074 Vehicle
Drug: Finasteride Placebo
Enrollment 458
Recruitment Details Study was conducted in 5 countries, in 52 sites and initiated on 02 Aug 2016 (First participant first visit) and the study got completed on 05 Mar 2018 (Last participant last visit).
Pre-assignment Details A total of 632 participants were screened, with 458 participants being randomized.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1-milligram (mg) tablet orally once daily for 24 weeks. Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks. Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for 24 weeks.
Period Title: Overall Study
Started 189 184 85
Completed 128 135 60
Not Completed 61 49 25
Reason Not Completed
Adverse Event             6             4             6
Lack of Efficacy             1             0             1
Lost to Follow-up             23             14             6
Non-Compliance with Study Drug             2             0             0
Protocol Violation             0             0             1
Withdrawal by Subject             29             27             10
Other unspecified reason             0             4             1
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle Total
Hide Arm/Group Description Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks. Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 189 184 85 458
Hide Baseline Analysis Population Description
The data presented here for the for all randomized participants in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 189 participants 184 participants 85 participants 458 participants
31.7  (5.4) 32.0  (4.8) 31.9  (5.6) 31.9  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 184 participants 85 participants 458 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
189
 100.0%
184
 100.0%
85
 100.0%
458
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 184 participants 85 participants 458 participants
Asian
2
   1.1%
1
   0.5%
0
   0.0%
3
   0.7%
Black/African American
0
   0.0%
0
   0.0%
1
   1.2%
1
   0.2%
Caucasian/White
187
  98.9%
181
  98.4%
83
  97.6%
451
  98.5%
Other
0
   0.0%
2
   1.1%
1
   1.2%
3
   0.7%
1.Primary Outcome
Title Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24
Hide Description The change from baseline in the TAHC within a 1 cm^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Overall Number of Participants Analyzed 105 97 48
Mean (Standard Deviation)
Unit of Measure: Hairs
20.2  (2.88) 6.7  (3.01) 21.1  (3.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 13.6
Confidence Interval (2-Sided) 95%
5.8 to 21.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.94
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12
Hide Description The change from baseline in the TAHC within a 1 cm^2 of baldness area at Week 12, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Overall Number of Participants Analyzed 105 97 48
Mean (Standard Deviation)
Unit of Measure: Hairs
20.4  (2.41) 7.6  (2.46) 22.5  (3.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 12.8
Confidence Interval (2-Sided) 95%
6.5 to 19.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.19
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24
Hide Description The change from baseline in the TAHW within a 1 cm^2 of baldness area at Weeks 12 and 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Weeks 12 and 24 minus baseline, respectively.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Overall Number of Participants Analyzed 105 97 48
Mean (Standard Deviation)
Unit of Measure: Micrometer
Week 12 -1.1231  (0.30653) -0.7207  (0.31033) -0.6938  (0.41951)
Week 24 -0.8052  (0.35151) -1.5289  (0.36691) 0.7163  (0.46679)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.322
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4024
Confidence Interval (2-Sided) 95%
-1.2020 to 0.3971
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.40570
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7237
Confidence Interval (2-Sided) 95%
-0.2184 to 1.6657
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.47799
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24
Hide Description Participants assessed their scalp hair using a validated, self-administered MHGQ, which was given in their language. The self-administered MHGQ overall score assessed using the following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. A higher score indicated a worse outcome. The questionnaire was administered to eligible participants to subjectively measure their perception of hair growth. A higher score indicated a worse outcome.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Overall Number of Participants Analyzed 105 97 48
Mean (Standard Error)
Unit of Measure: score on a scale
Week 12 2.9  (0.08) 3.0  (0.09) 2.8  (0.12)
Week 24 2.8  (0.09) 3.0  (0.10) 2.9  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.569
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.4 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24
Hide Description The local Investigator assessed change in hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale. The evaluation was done by the Investigator or designee, by comparing the global vertex view photograph obtained at baseline visit with the participants actual scalp at 12 and 24 weeks. For the purpose of assessment of changes in hair growth by Investigators screening visits (where global photos were taken) were used as Baseline. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Overall Number of Participants Analyzed 105 97 48
Mean (Standard Error)
Unit of Measure: score on a scale
Week 12 0.5  (0.10) 0.4  (0.11) 0.5  (0.15)
Week 24 0.8  (0.09) 0.3  (0.09) 0.7  (12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.2 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor
Hide Description An independent blinded assessor was responsible for evaluating, under blinded conditions, the screening global photographs of the target area for all participants. They evaluated the eligibility of each participants according to the clinical inclusion criteria. The independent blinded assessor assessed the change of the hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. This assessment was performed by comparing the global photographs obtained at screening visit with those subsequently obtained at Weeks 12 and 24. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Overall Number of Participants Analyzed 105 97 48
Mean (Standard Error)
Unit of Measure: score on a scale
Week 12 0.0  (0.08) 0.2  (0.08) 0.2  (0.11)
Week 24 0.2  (0.09) 0.1  (0.09) 0.3  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.262
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24
Hide Description The 15-question IIEF-2 Questionnaire (Sexual Function Questionnaire) was used to evaluate any changes in sexual function and activity, at Weeks 4, 8, 12 and 24. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Erectile function domain has 6 questions with the score for domain range from 0-30. Orgasmic function domain has 2 questions with the score for domain range from 0-10. , Sexual desire function domain has 2 questions with the score for domain range from 0-10. Intercourse satisfaction function domain has 3 questions with the score for domain range from 0-15. Overall Satisfaction domain has 2 questions with the score for domain range from 0-10. A higher score indicated a worse outcome in that domain.
Time Frame Weeks 4, 8, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Overall Number of Participants Analyzed 105 97 48
Mean (Standard Error)
Unit of Measure: score on a scale
Erectile Function Score, Week 4 24.5  (0.76) 26.2  (0.79) 23.5  (1.08)
Erectile Function Score, Week 8 24.3  (0.80) 24.9  (0.83) 24.4  (1.15)
Erectile Function Score, Week 12 25.3  (0.73) 25.5  (0.77) 23.6  (1.04)
Erectile Function Score, Week 24 25.3  (0.74) 26.1  (0.79) 24.9  (1.05)
Orgasmic Function Score, Week 4 9.3  (0.21) 9.0  (0.22) 8.9  (0.30)
Orgasmic Function Score, Week 8 8.7  (0.26) 8.7  (0.27) 9.1  (0.38)
Orgasmic Function Score, Week 12 9.4  (0.21) 8.9  (0.22) 9.0  (0.30)
Orgasmic Function Score, Week 24 8.9  (0.25) 9.1  (0.26) 9.0  (0.35)
Sexual Desire Score, Week 4 7.3  (0.17) 7.5  (0.17) 7.1  (0.24)
Sexual Desire Score, Week 8 7.4  (0.16) 7.4  (0.17) 7.6  (0.23)
Sexual Desire Score, Week 12 7.7  (0.15) 8.0  (0.16) 7.8  (0.21)
Sexual Desire Score, Week 24 7.7  (0.17) 7.7  (0.18) 7.8  (0.24)
Intercourse Satisfaction Score, Week 4 9.4  (0.49) 10.7  (0.51) 8.5  (0.69)
Intercourse Satisfaction Score, Week 8 9.6  (0.49) 9.9  (0.51) 9.0  (0.70)
Intercourse Satisfaction Score, Week 12 9.9  (0.49) 10.2  (0.51) 8.3  (0.69)
Intercourse Satisfaction Score, Week 24 9.8  (0.47) 10.8  (0.50) 8.9  (0.67)
Overall Satisfaction Score, Week 4 7.9  (0.22) 8.0  (0.22) 7.9  (0.31)
Overall Satisfaction Score, Week 8 7.9  (0.21) 7.8  (0.22) 7.8  (0.31)
Overall Satisfaction Score, Week 12 8.1  (0.22) 8.1  (0.23) 7.6  (0.31)
Overall Satisfaction Score, Week 24 8.0  (0.22) 8.1  (0.23) 8.2  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Erectile Function Score, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-3.7 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Erectile Function Score, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.545
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.8 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Erectile Function Score, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.842
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-2.2 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Erectile Function Score, Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-2.8 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Orgasmic Function Score, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.272
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.2 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Orgasmic Function Score, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.918
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Orgasmic Function Score, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.1 to 1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.078
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Orgasmic Function Score, Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.593
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.9 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Sexual Desire Score, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.295
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.7 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Sexual Desire Score, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.926
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.5 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Sexual Desire Score, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.7 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Sexual Desire Score, Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.981
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.4 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.7 to -0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.562
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.7 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.67
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.642
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.6 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.2 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Overall Satisfaction Score, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.824
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.6 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Overall Satisfaction Score, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.713
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Overall Satisfaction Score, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.6 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection P-3074 + Finasteride Placebo, P-3074 Vehicle + Finasteride Placebo
Comments Statistical Analysis details presented here is for Overall Satisfaction Score, Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.550
Comments [Not Specified]
Method Mixed linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.8 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale
Hide Description Local tolerability at the application site was assessed to rate the severity of any skin irritation. The Investigator used the Severity score for skin Irritation scale to assess local tolerability. The dermal response and other effects indicative irritation responses were recorded at time of examination. Anything other than “No evidence of irritation” under Dermal Response was considered as a Dermal Response Skin Irritation event. Anything other than “No other effects” under Other Effects was considered as an Other Effects of Skin Irritation event. The event incidence rate is calculated as the number of events interest divided by total personal time in years.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all randomized participants who received at least one application of the IMP.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Overall Number of Participants Analyzed 181 181 84
Measure Type: Number
Unit of Measure: Events per personal years
Dermal Response 0.340 0.245 0.661
Other Effects 0.368 0.463 0.755
9.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Hide Description An Adverse event is defined as any untoward medical occurrence in a participants or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and medically significant event. The Treatment Emergent Adverse Events (TEAEs) is defined as all AEs occurring on or after the first dose of the IMP.
Time Frame From the start of IMP up to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all randomized participants who received at least one application of the IMP.
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Overall Number of Participants Analyzed 181 181 84
Measure Type: Number
Unit of Measure: participants
TEAEs 75 76 41
Serious TEAEs 4 5 1
Time Frame From the start of the IMP up to 28 weeks
Adverse Event Reporting Description The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.
 
Arm/Group Title P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Hide Arm/Group Description Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks. Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks. Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
All-Cause Mortality
P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/181 (3.31%)      5/181 (2.76%)      1/84 (1.19%)    
Show Serious Adverse Events Hide Serious Adverse Events
P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/181 (2.21%)      5/181 (2.76%)      1/84 (1.19%)    
Injury, poisoning and procedural complications       
Ankle fracture * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Exposure via father * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Road traffic accident * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 1/84 (1.19%)  1
Skull fractured base * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Tendonitis * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Nasal septum deviation * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Pneumothorax spontaneous * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Vascular disorders       
Haematoma * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Hypertension * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
P-3074 + Finasteride Placebo P-3074 Vehicle + Finasteride Placebo Oral Finasteride + P-3074 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/181 (40.88%)      73/181 (40.33%)      40/84 (47.62%)    
Blood and lymphatic system disorders       
Lymphadenopathy * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 1/84 (1.19%)  1
Cardiac disorders       
Sinus arrhythmia * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Tachycardia * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Ear and labyrinth disorders       
Vertigo * 1  1/181 (0.55%)  1 1/181 (0.55%)  1 0/84 (0.00%)  0
Eye disorders       
Blepharitis * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain * 1  1/181 (0.55%)  1 1/181 (0.55%)  1 0/84 (0.00%)  0
Abdominal pain upper * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 1/84 (1.19%)  1
Anal pruritus * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Crohn's disease * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Dental caries * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Diarrhoea * 1  2/181 (1.10%)  2 2/181 (1.10%)  2 2/84 (2.38%)  2
Dyspepsia * 1  0/181 (0.00%)  0 2/181 (1.10%)  3 1/84 (1.19%)  2
Dysphagia * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Food poisoning * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Gastritis * 1  2/181 (1.10%)  2 1/181 (0.55%)  1 0/84 (0.00%)  0
Inguinal hernia perforation * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Nausea * 1  0/181 (0.00%)  0 3/181 (1.66%)  3 0/84 (0.00%)  0
Odynophagia * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Stomatitis * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Toothache * 1  3/181 (1.66%)  3 3/181 (1.66%)  3 2/84 (2.38%)  3
Vomiting * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
General disorders       
Application site pain * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Application site pruritus * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Chest discomfort * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Face oedema * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Fatigue * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Influenza like illness * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Non-cardiac chest pain * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Peripheral swelling * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Pyrexia * 1  3/181 (1.66%)  4 1/181 (0.55%)  2 1/84 (1.19%)  1
Thirst * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Hepatobiliary disorders       
Hepatocellular injury * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Hypertransaminasaemia * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Immune system disorders       
Dust allergy * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Infections and infestations       
Acute sinusitis * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Anorectal infection * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Bronchitis * 1  1/181 (0.55%)  1 2/181 (1.10%)  2 0/84 (0.00%)  0
Conjunctivitis * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Epididymitis * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Gastritis helminthic * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Gastroenteritis * 1  2/181 (1.10%)  2 4/181 (2.21%)  4 1/84 (1.19%)  1
Gastrointestinal infection * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 1/84 (1.19%)  1
Herpes simplex * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Hordeolum * 1  0/181 (0.00%)  0 2/181 (1.10%)  2 0/84 (0.00%)  0
Infected bite * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Influenza * 1  4/181 (2.21%)  4 2/181 (1.10%)  2 1/84 (1.19%)  1
Laryngitis * 1  1/181 (0.55%)  1 1/181 (0.55%)  1 1/84 (1.19%)  1
Nasopharyngitis * 1  28/181 (15.47%)  32 24/181 (13.26%)  29 15/84 (17.86%)  22
Oral herpes * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 1/84 (1.19%)  1
Otitis externa * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Otitis media acute * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Periodontitis * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Pertussis * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Pharyngitis * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Pulpitis dental * 1  1/181 (0.55%)  1 1/181 (0.55%)  1 0/84 (0.00%)  0
Rash pustular * 1  1/181 (0.55%)  2 0/181 (0.00%)  0 0/84 (0.00%)  0
Respiratory tract infection * 1  1/181 (0.55%)  1 1/181 (0.55%)  1 0/84 (0.00%)  0
Respiratory tract infection viral * 1  3/181 (1.66%)  3 0/181 (0.00%)  0 0/84 (0.00%)  0
Rhinitis * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Sinusitis * 1  1/181 (0.55%)  1 2/181 (1.10%)  2 1/84 (1.19%)  1
Testicular abscess * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Tonsillitis * 1  0/181 (0.00%)  0 3/181 (1.66%)  4 0/84 (0.00%)  0
Tooth infection * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Urinary tract infection * 1  2/181 (1.10%)  3 1/181 (0.55%)  1 0/84 (0.00%)  0
Viral infection * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Injury, poisoning and procedural complications       
Arthropod bite * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Contusion * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Fall * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Foot fracture * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Injury * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Joint dislocation * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Laceration * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Ligament rupture * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Meniscus injury * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Skin abrasion * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Skin injury * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Upper limb fracture * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Investigations       
Alanine aminotransferase increased * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Aspartate aminotransferase increased * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 1/84 (1.19%)  1
Blood bilirubin increased * 1  1/181 (0.55%)  2 0/181 (0.00%)  0 0/84 (0.00%)  0
Blood bilirubin unconjugated increased * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Blood glucose increased * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Blood pressure systolic increased * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Blood uric acid increased * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Crystal urine present * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 1/84 (1.19%)  1
Gamma-glutamyltransferase increased * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 2/84 (2.38%)  2
Liver function test increased * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Protein urine present * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Red blood cells urine positive * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Stress echocardiogram abnormal * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Transaminases increased * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Weight increased * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
White blood cells urine positive * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Hypercholesterolaemia * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Hypophosphataemia * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Vitamin B12 deficiency * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Vitamin D deficiency * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Back pain * 1  2/181 (1.10%)  2 5/181 (2.76%)  6 1/84 (1.19%)  1
Bone pain * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Bursitis * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Muscle tightness * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Musculoskeletal pain * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Musculoskeletal stiffness * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Myalgia * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Pain in extremity * 1  1/181 (0.55%)  1 2/181 (1.10%)  2 0/84 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Nervous system disorders       
Carpal tunnel syndrome * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Cervicogenic headache * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Dizziness * 1  1/181 (0.55%)  1 2/181 (1.10%)  4 0/84 (0.00%)  0
Head discomfort * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Headache * 1  17/181 (9.39%)  25 20/181 (11.05%)  29 8/84 (9.52%)  9
Hyperaesthesia * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Paraesthesia * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Presyncope * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Sciatica * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Somnolence * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Syncope * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Psychiatric disorders       
Anxiety * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 1/84 (1.19%)  2
Burnout syndrome * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Depression * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 1/84 (1.19%)  1
Initial insomnia * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Insomnia * 1  1/181 (0.55%)  1 1/181 (0.55%)  1 0/84 (0.00%)  0
Libido decreased * 1  1/181 (0.55%)  1 3/181 (1.66%)  3 1/84 (1.19%)  1
Loss of libido * 1  0/181 (0.00%)  0 2/181 (1.10%)  2 3/84 (3.57%)  3
Stress * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Renal and urinary disorders       
Dysuria * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Proteinuria * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Reproductive system and breast disorders       
Balanoposthitis * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Erectile dysfunction * 1  2/181 (1.10%)  2 2/181 (1.10%)  2 2/84 (2.38%)  2
Sexual dysfunction * 1  2/181 (1.10%)  2 0/181 (0.00%)  0 0/84 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Catarrh * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Cough * 1  1/181 (0.55%)  1 2/181 (1.10%)  2 0/84 (0.00%)  0
Dyspnoea * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Nasal pruritus * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Oropharyngeal pain * 1  1/181 (0.55%)  1 7/181 (3.87%)  7 3/84 (3.57%)  3
Rhinitis allergic * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Rhinorrhoea * 1  2/181 (1.10%)  2 0/181 (0.00%)  0 0/84 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermal cyst * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Diffuse alopecia * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Eczema * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Erythema * 1  4/181 (2.21%)  5 0/181 (0.00%)  0 0/84 (0.00%)  0
Papule * 1  1/181 (0.55%)  3 1/181 (0.55%)  2 0/84 (0.00%)  0
Pruritus * 1  5/181 (2.76%)  5 1/181 (0.55%)  3 1/84 (1.19%)  1
Pruritus generalised * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Rash * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Rash papular * 1  2/181 (1.10%)  2 0/181 (0.00%)  0 0/84 (0.00%)  0
Rash pruritic * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Rash vesicular * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Sebaceous gland disorder * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Seborrhoeic dermatitis * 1  0/181 (0.00%)  0 2/181 (1.10%)  2 0/84 (0.00%)  0
Skin burning sensation * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Skin irritation * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Skin plaque * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Urticaria * 1  0/181 (0.00%)  0 0/181 (0.00%)  0 1/84 (1.19%)  1
Vitiligo * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
Social circumstances       
High risk sexual behaviour * 1  0/181 (0.00%)  0 1/181 (0.55%)  1 0/84 (0.00%)  0
Stress at work * 1  1/181 (0.55%)  1 0/181 (0.00%)  0 0/84 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Francesco Scarci
Organization: Polichem S.A.
Phone: +41 091 9864 005
Responsible Party: Polichem S.A.
ClinicalTrials.gov Identifier: NCT03004469     History of Changes
Other Study ID Numbers: PM1541
First Submitted: December 23, 2016
First Posted: December 28, 2016
Results First Submitted: February 27, 2019
Results First Posted: April 19, 2019
Last Update Posted: April 19, 2019