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A Study To Evaluate The Safety And Therapeutic Equivalence of Tazarotene Foam 0.1% in Subjects With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02267746
Recruitment Status : Completed
First Posted : October 17, 2014
Results First Posted : May 11, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Actavis Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Tazarotene (Fabior™)
Drug: Tazarotene (Actavis)
Drug: Vehicle foam
Enrollment 893
Recruitment Details  
Pre-assignment Details 893 subjects were randomized and analyzed; 869 qualified for the mITT population and 758 for the PP population.
Arm/Group Title Test Reference Vehicle
Hide Arm/Group Description Tazarotene 0.1% foam (Actavis LLC) Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC) Vehicle foam of the test product (Actavis LLC)
Period Title: Overall Study
Started 298 296 299
Completed 277 274 278
Not Completed 21 22 21
Reason Not Completed
Adverse Event             0             2             1
Protocol Violation             8             7             3
Lack of Efficacy             11             11             15
Protocol Violation             1             2             1
Miscellaneous             1             0             1
Arm/Group Title Test Reference Vehicle Total
Hide Arm/Group Description Tazarotene 0.1% foam (Actavis LLC) Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC) Vehicle foam of the test product (Actavis LLC) Total of all reporting groups
Overall Number of Baseline Participants 292 288 294 874
Hide Baseline Analysis Population Description
A total of 874 (97.9%) of the 893 randomized subjects applied study treatment during the baseline visit, and were therefore retained in the Safety population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 292 participants 288 participants 294 participants 874 participants
21.5  (7.76) 21.1  (7.26) 21.0  (7.03) 21.2  (7.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants 288 participants 294 participants 874 participants
Female
113
  38.7%
107
  37.2%
107
  36.4%
327
  37.4%
Male
179
  61.3%
181
  62.8%
187
  63.6%
547
  62.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants 288 participants 294 participants 874 participants
Hispanic or Latino
118
  40.4%
110
  38.2%
115
  39.1%
343
  39.2%
Not Hispanic or Latino
174
  59.6%
178
  61.8%
179
  60.9%
531
  60.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants 288 participants 294 participants 874 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
Asian
4
   1.4%
6
   2.1%
5
   1.7%
15
   1.7%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
2
   0.7%
3
   0.3%
Black or African American
109
  37.3%
116
  40.3%
91
  31.0%
316
  36.2%
White
177
  60.6%
160
  55.6%
193
  65.6%
530
  60.6%
More than one race
1
   0.3%
5
   1.7%
3
   1.0%
9
   1.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts
Hide Description For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e., the lines around the nostrils and under the nostrils) and all mucus membranes.
Time Frame Mean percent change from baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Mean percent change from baseline to Week 12 in Per Protocol Population
Arm/Group Title Test Reference Vehicle
Hide Arm/Group Description:
Tazarotene 0.1% foam (Actavis LLC)
Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)
Placebo foam (Actavis LLC)
Overall Number of Participants Analyzed 187 185 195
Mean (Standard Deviation)
Unit of Measure: Percent change in inflammatory lesions
-48.25  (26.743) -52.72  (22.792) -45.03  (24.092)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Reference
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.93
Confidence Interval (2-Sided) 90%
0.86 to 1.02
Estimation Comments Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval [0.80, 1.25] for the PP population.
2.Primary Outcome
Title Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts
Hide Description Estimates of mean percent change from baseline for non-inflammatory lesions for the Test and Reference treatment.
Time Frame Mean percent change from baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Percent change in the non-inflammatory lesions in Per Protocol Population.
Arm/Group Title Test Reference Vehicle Foam
Hide Arm/Group Description:
Tazarotene 0.1% foam (Actavis LLC)
Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)
Placebo Foam (Actavis LLC)
Overall Number of Participants Analyzed 187 185 195
Mean (Standard Deviation)
Unit of Measure: percent change in noninflammatory lesion
-41.98  (21.125) -44.51  (20.062) -37.42  (24.126)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Reference
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.89 to 1.04
Estimation Comments Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval [0.80, 1.25] for the PP population.
3.Secondary Outcome
Title The Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment
Hide Description [Not Specified]
Time Frame IGA score at Week 12 compared to baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment success based on IGA score at Week 12 in PP population
Arm/Group Title Test Reference Vehicle
Hide Arm/Group Description:
Tazarotene 0.1% foam (Actavis LLC)
Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)
Vehicle foam of the test product (Actavis LLC)
Overall Number of Participants Analyzed 252 247 259
Measure Type: Count of Participants
Unit of Measure: Participants
Success
103
  40.9%
119
  48.2%
88
  34.0%
Failure
149
  59.1%
128
  51.8%
171
  66.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Reference
Comments Success was defined as an IGA score at Week 12 that was at least two grades less than the baseline assessment. Failure was defined as an IGA score that was the same, higher, or one grade lower than the baseline assessment.
Type of Statistical Test Equivalence
Comments Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval [-0.20, +0.20] for PP population.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.073
Confidence Interval (2-Sided) 90%
-0.150 to 0.004
Estimation Comments Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval [-0.20, +0.20] for the PP population.
Time Frame Adverse event data were collected over approximately 13 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Reference Vehicle
Hide Arm/Group Description Tazarotene 0.1% foam (Actavis LLC) Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC) Vehicle foam of the test product (Actavis LLC)
All-Cause Mortality
Test Reference Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/292 (0.00%)   0/288 (0.00%)   0/294 (0.00%) 
Hide Serious Adverse Events
Test Reference Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/292 (0.00%)   0/288 (0.00%)   0/294 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test Reference Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/292 (14.04%)   55/288 (19.10%)   43/294 (14.63%) 
Eye disorders       
Eye Pain  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Eye Pruritis  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Eye swelling  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/292 (0.34%)  1/288 (0.35%)  0/294 (0.00%) 
Abdominal pain upper  1  1/292 (0.34%)  2/288 (0.69%)  1/294 (0.34%) 
Diarrhoea  1  2/292 (0.68%)  2/288 (0.69%)  2/294 (0.68%) 
Dry mouth  1  1/292 (0.34%)  0/288 (0.00%)  0/294 (0.00%) 
Lip swelling  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Nausea  1  0/292 (0.00%)  3/288 (1.04%)  0/294 (0.00%) 
Oral pain  1  0/292 (0.00%)  2/288 (0.69%)  0/294 (0.00%) 
Toothache  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
General disorders       
Application site reaction  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Chest pain  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Cyst  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Influenza like illness  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Pyrexia  1  1/292 (0.34%)  1/288 (0.35%)  1/294 (0.34%) 
Immune system disorders       
Food allergy  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Infections and infestations       
Influenza  1  4/292 (1.37%)  5/288 (1.74%)  5/294 (1.70%) 
Localized infection  1  1/292 (0.34%)  0/288 (0.00%)  0/294 (0.00%) 
Nasopharyngitis  1  7/292 (2.40%)  5/288 (1.74%)  9/294 (3.06%) 
Rhinitis  1  1/292 (0.34%)  0/288 (0.00%)  0/294 (0.00%) 
Sinusitis  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Upper respiratory tract infection  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Injury, poisoning and procedural complications       
Arthropod bite  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Ligament sprain  1  0/292 (0.00%)  1/288 (0.35%)  1/294 (0.34%) 
Thermal burn  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Investigations       
Heart rate increased  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/292 (0.34%)  0/288 (0.00%)  0/294 (0.00%) 
Back pain  1  2/292 (0.68%)  1/288 (0.35%)  0/294 (0.00%) 
Muscle spasms  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Neck pain  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Nervous system disorders       
Burning sensation  1  1/292 (0.34%)  1/288 (0.35%)  1/294 (0.34%) 
Headache  1  12/292 (4.11%)  17/288 (5.90%)  20/294 (6.80%) 
Migraine  1  0/292 (0.00%)  1/288 (0.35%)  1/294 (0.34%) 
Sinus headache  1  0/292 (0.00%)  1/288 (0.35%)  1/294 (0.34%) 
Tension headache  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Psychiatric disorders       
Anxiety  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Depression  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Sleep disorder  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  7/292 (2.40%)  3/288 (1.04%)  5/294 (1.70%) 
Ovarian cyst  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/292 (0.00%)  1/288 (0.35%)  1/294 (0.34%) 
Nasal congestion  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Oropharyngeal pain  1  1/292 (0.34%)  1/288 (0.35%)  2/294 (0.68%) 
Rhinorrhoea  1  1/292 (0.34%)  1/288 (0.35%)  0/294 (0.00%) 
Sneezing  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Acne  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  1/292 (0.34%)  2/288 (0.69%)  0/294 (0.00%) 
Erythema  1  1/292 (0.34%)  2/288 (0.69%)  1/294 (0.34%) 
Hyperhidrosis  1  0/292 (0.00%)  1/288 (0.35%)  0/294 (0.00%) 
Pruritus  1  1/292 (0.34%)  2/288 (0.69%)  1/294 (0.34%) 
Rash  1  1/292 (0.34%)  2/288 (0.69%)  0/294 (0.00%) 
Rash erythematous  1  0/292 (0.00%)  0/288 (0.00%)  1/294 (0.34%) 
Skin exfoliation  1  2/292 (0.68%)  0/288 (0.00%)  0/294 (0.00%) 
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by 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.
The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, CE Studies
Organization: Teva Pharmaceuticals USA, Inc.
Phone: 1-888-483-8279
EMail: USMedinfo@tevapharm.com
Layout table for additonal information
Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT02267746    
Other Study ID Numbers: WAT 14-1096
First Submitted: October 14, 2014
First Posted: October 17, 2014
Results First Submitted: April 7, 2020
Results First Posted: May 11, 2020
Last Update Posted: June 12, 2020