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A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne

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ClinicalTrials.gov Identifier: NCT00887484
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : October 23, 2012
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: BENZOYL PEROXIDE/ CLINDAMYCIN
Drug: BENZOYL PEROXIDE/ ADAPALENE
Enrollment 50

Recruitment Details Clinical research center
Pre-assignment Details  
Arm/Group Title Clindoxyl and Epiduo Gels
Hide Arm/Group Description Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
Period Title: Split Face Treatment (Weeks 1 and 2)
Started 48
Completed 48
Not Completed 0
Period Title: Full Face Treatment (Weeks 5 and 8)
Started 48
Completed 45
Not Completed 3
Reason Not Completed
Adverse Event             1
Lost to Follow-up             1
Pregnancy             1
Arm/Group Title Clindoxyl and Epiduo Gels
Hide Arm/Group Description Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
27.6  (5.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
10
  20.8%
Male
38
  79.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Hispanic or Latino
33
  68.8%
Not Hispanic or Latino
15
  31.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
48
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Argentina Number Analyzed 48 participants
48
Investigators Static Global Assessment (ISGA)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants
Mild 14
Moderate 31
Severe 3
[1]
Measure Description: The investigator rated the participants’ skin using the 6-point ISGA: 0=clear, clear skin with no inflammatory lesions (ILs) or non-ILs; 1=almost clear, rare non-ILs with no more than one small IL; 2=mild, some non-ILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many non-ILs and may have some ILs, but no more than one small NL; 4=severe, up to many non-IL and ILs, but no more than a few NLs; 5=many non-IL and ILs and more than a few NLs. May have cystic lesions. Participants with grades of 2-4 were eligible for enrollment in this study.
Inflammatory Acne Lesion Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Inflammatory lesions
Number Analyzed 48 participants
14.2  (9.1)
[1]
Measure Description: Inflammatory acne lesion count at baseline (number of pustules and papules).
Non-Inflammatory Acne Lesion Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Non-Infammatory acne lesions
Number Analyzed 48 participants
24.8  (12.8)
[1]
Measure Description: Non-Inflammatory acne lesion count at baseline (number of whiteheads and blackheads)
Total Acne Lesion Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Acne lesions
Number Analyzed 48 participants
39.1  (13.0)
[1]
Measure Description: Total acne lesion count (includes inflammatory and non-inflammatory lesions)
1.Primary Outcome
Title Erythema (Redness)
Hide Description

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT)
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 0.66  (0.70) 0.91  (0.78)
Week 2 0.55  (0.62) 0.74  (0.64)
2.Primary Outcome
Title Skin Dryness
Hide Description

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 0.47  (0.55) 0.96  (0.75)
Week 2 0.40  (0.58) 0.64  (0.74)
3.Primary Outcome
Title Skin Peeling
Hide Description

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense.

Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 0.34  (0.52) 0.68  (0.78)
Week 2 0.40  (0.61) 0.60  (0.68)
4.Primary Outcome
Title Irritant/Allergic Contact Dermatitis
Hide Description

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 0.04  (0.20) 0.04  (0.20)
Week 2 0.04  (0.20) 0.04  (0.20)
5.Secondary Outcome
Title Erythema (Redness)
Hide Description

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time Frame Weeks 5 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 5 0.22  (0.42)
Week 8 0.19  (0.50)
6.Secondary Outcome
Title Skin Dryness
Hide Description

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time Frame Weeks 5 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 5 0.20  (0.46)
Week 8 0.04  (0.29)
7.Secondary Outcome
Title Skin Peeling
Hide Description

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time Frame Weeks 5 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 5 0.13  (0.40)
Week 8 0.06  (0.25)
8.Secondary Outcome
Title Irritant/Allergic Contact Dermatitis
Hide Description

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time Frame Weeks 5 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 5 0.00  (0.00)
Week 8 0.00  (0.00)
9.Secondary Outcome
Title Investigators Static Global Assessment
Hide Description ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.
Time Frame Baseline, Weeks 5, 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For the first 2 weeks, participants apply one of the drugs (Clindoxyl or Epiduo) to one side of the face and the other drug to the other side of their face. After week 2, participants apply Clindoxyl to their entire face and do not use Epiduo.
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.77  (0.56)
Week 5 1.89  (0.75)
Week 8 1.62  (0.92)
10.Secondary Outcome
Title Total Acne Lesion Counts
Hide Description Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Time Frame Baseline, Weeks 5 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Acne Lesions
Baseline 39.06  (12.95)
Week 5 15.96  (10.37)
Week 8 13.77  (11.50)
11.Secondary Outcome
Title Inflammatory Acne Lesion Counts
Hide Description Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Time Frame Baseline, Weeks 5 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Acne Lesions
Baseline 14.23  (9.06)
Week 5 4.60  (3.93)
Week 8 4.26  (5.84)
12.Secondary Outcome
Title Non-inflammatory Acne Lesion Counts
Hide Description Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Time Frame Baseline, Weeks 5 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Acne Lesions
Baseline 24.83  (12.84)
Week 5 11.36  (7.89)
Week 8 9.51  (8.53)
13.Secondary Outcome
Title Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
Hide Description Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28.
Time Frame Baseline, Weeks 2 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 20.91  (15.73)
Week 2 21.58  (14.17)
Week 8 13.75  (14.03)
14.Secondary Outcome
Title Quality of Life Questionnaire - Emotional Domain
Hide Description Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40.
Time Frame Baseline, Weeks 2 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 25.32  (19.73)
Week 2 19.38  (18.68)
Week 8 16.42  (19.08)
15.Secondary Outcome
Title Quality of Life Questionnaire - Functional Domain
Hide Description Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48.
Time Frame Baseline, Weeks 2 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 8.59  (13.98)
Week 2 6.30  (11.77)
Week 8 5.19  (11.78)
16.Secondary Outcome
Title Quality of Life Questionnaire - Global Score
Hide Description Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116.
Time Frame Baseline, Weeks 2 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 8.59  (13.98)
Week 2 6.30  (11.77)
Week 8 5.19  (11.78)
17.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 1.09  (1.18) 1.72  (1.21)
Week 2 0.72  (0.86) 1.15  (1.07)
18.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8
Hide Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.77  (1.09)
19.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 1.30  (1.14) 1.81  (1.14)
Week 2 1.00  (0.87) 1.41  (1.17)
20.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8
Hide Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.64  (0.97)
21.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 0.91  (1.23) 1.68  (1.20)
Week 2 0.72  (0.89) 1.30  (1.23)
22.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8
Hide Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.36  (0.76)
23.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 0.64  (1.11) 1.02  (1.34)
Week 2 0.72  (0.96) 0.93  (1.00)
24.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8
Hide Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.26  (0.49)
25.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 0.79  (1.18) 1.43  (1.41)
Week 2 0.59  (0.69) 1.04  (1.07)
26.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8
Hide Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.45  (0.83)
27.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 1.30  (0.51) 1.32  (0.56)
Week 2 1.35  (0.53) 1.39  (0.61)
28.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8
Hide Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
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ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.26  (0.44)
29.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.
Time Frame Weeks 1 and 2
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ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 2.81  (0.88) 3.15  (1.08)
Week 2 2.39  (0.93) 2.67  (0.94)
30.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.
Time Frame Week 8
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Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.83  (0.92)
31.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.
Time Frame Weeks 1 and 2
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ITT. Data are presented for only those participants completing the questionnaire.
Arm/Group Title All Subjects
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Subjects applied both study products in a split-face fashion through week 2. Study products were applied once-daily in the evening.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: Participants
Week 1, Epiduo Gel, n=47 15
Week 1, Clindoxyl Gel, n=47 30
Week 1, Both Treatments Equally, n=47 2
Week 2, Epiduo Gel, n=46 16
Week 2, Clindoxyl Gel, n=46 29
Week 2, Both Treatments Equally, n=46 1
32.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8
Hide Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied.
Time Frame Week 8
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Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.63  (1.08)
33.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable.
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 1.87  (0.68) 2.04  (0.78)
Week 2 1.85  (0.84) 2.00  (0.70)
34.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8
Hide Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.53  (0.65)
35.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant.
Time Frame Weeks 1 and 2
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Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 1.91  (0.28) 1.91  (0.28)
Week 2 1.85  (0.42) 1.85  (0.42)
36.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Compliance at Week 8
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
Yes 43
No 3
37.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?
Time Frame Weeks 1 and 2
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Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Measure Type: Number
Unit of Measure: Participants
Week 1 - Yes 16 12
Week 1 - No 31 35
Week 2 - Yes 14 11
Week 2 - No 32 35
38.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
Yes 28
No 18
39.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Measure Type: Number
Unit of Measure: Participants
Week 1 - Yes 44 26
Week 1 - No 3 21
Week 2 - Yes 39 32
Week 2 - No 7 14
40.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
Yes 41
No 5
41.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 2.23  (1.24) 2.31  (1.38)
Week 2 1.75  (0.93) 1.75  (0.93)
42.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.69  (0.87)
43.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.
Time Frame Weeks 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel Epiduo Gel
Hide Arm/Group Description:
Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 2.09  (0.69) 2.23  (0.87)
Week 2 1.76  (0.77) 1.98  (0.68)
44.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8
Hide Description Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Clindoxyl Gel
Hide Arm/Group Description:
Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.61  (0.98)
Time Frame Baseline through Week 8.
Adverse Event Reporting Description Any study product-related AEs ongoing at the end of the treatment period will be followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs will be followed until resolution as previously stated for study product-related AEs.
 
Arm/Group Title Clindoxyl and Epiduo Gels
Hide Arm/Group Description Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
All-Cause Mortality
Clindoxyl and Epiduo Gels
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clindoxyl and Epiduo Gels
Affected / at Risk (%) # Events
Total   0/48 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clindoxyl and Epiduo Gels
Affected / at Risk (%) # Events
Total   44/48 (91.67%)    
Skin and subcutaneous tissue disorders   
Application site irritation * 1  36/48 (75.00%)  36
Application site dryness * 1  19/48 (39.58%)  19
Application site pruritus * 1  11/48 (22.92%)  11
Application site exfoliation * 1  10/48 (20.83%)  10
Drug intolerance * 1  4/48 (8.33%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
If the Investigator wishes to make any such publication or presentation, the Investigator must first submit such publication or presentation to Stiefel for review at least thirty (30) days prior to the date on which such publication or presentation is proposed to be made.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 888-435-7343
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00887484     History of Changes
Other Study ID Numbers: 114544
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: September 22, 2010
Results First Posted: October 23, 2012
Last Update Posted: December 13, 2016