Trial Outcomes & Findings for A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne (NCT NCT00887484)
NCT ID: NCT00887484
Last Updated: 2016-12-13
Results Overview
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.
COMPLETED
PHASE4
50 participants
Weeks 1 and 2
2016-12-13
Participant Flow
Clinical research center
Participant milestones
| Measure |
Clindoxyl and Epiduo Gels
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.
|
|---|---|
|
Split Face Treatment (Weeks 1 and 2)
STARTED
|
48
|
|
Split Face Treatment (Weeks 1 and 2)
COMPLETED
|
48
|
|
Split Face Treatment (Weeks 1 and 2)
NOT COMPLETED
|
0
|
|
Full Face Treatment (Weeks 5 and 8)
STARTED
|
48
|
|
Full Face Treatment (Weeks 5 and 8)
COMPLETED
|
45
|
|
Full Face Treatment (Weeks 5 and 8)
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Clindoxyl and Epiduo Gels
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.
|
|---|---|
|
Full Face Treatment (Weeks 5 and 8)
Adverse Event
|
1
|
|
Full Face Treatment (Weeks 5 and 8)
Lost to Follow-up
|
1
|
|
Full Face Treatment (Weeks 5 and 8)
Pregnancy
|
1
|
Baseline Characteristics
A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
Baseline characteristics by cohort
| Measure |
Clindoxyl and Epiduo Gels
n=48 Participants
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.
|
|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
|
Gender
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
48 participants
n=5 Participants
|
|
Investigators Static Global Assessment (ISGA)
Mild
|
14 Participants
n=5 Participants
|
|
Investigators Static Global Assessment (ISGA)
Moderate
|
31 Participants
n=5 Participants
|
|
Investigators Static Global Assessment (ISGA)
Severe
|
3 Participants
n=5 Participants
|
|
Inflammatory Acne Lesion Count
|
14.2 Inflammatory lesions
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Non-Inflammatory Acne Lesion Count
|
24.8 Non-Infammatory acne lesions
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Total Acne Lesion Count
|
39.1 Acne lesions
STANDARD_DEVIATION 13.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1 and 2Population: Intent-to-Treat (ITT)
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Erythema (Redness)
Week 1
|
0.66 units on a scale
Standard Deviation 0.70
|
0.91 units on a scale
Standard Deviation 0.78
|
|
Erythema (Redness)
Week 2
|
0.55 units on a scale
Standard Deviation 0.62
|
0.74 units on a scale
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Skin Dryness
Week 1
|
0.47 units on a scale
Standard Deviation 0.55
|
0.96 units on a scale
Standard Deviation 0.75
|
|
Skin Dryness
Week 2
|
0.40 units on a scale
Standard Deviation 0.58
|
0.64 units on a scale
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Skin Peeling
Week 1
|
0.34 units on a scale
Standard Deviation 0.52
|
0.68 units on a scale
Standard Deviation 0.78
|
|
Skin Peeling
Week 2
|
0.40 units on a scale
Standard Deviation 0.61
|
0.60 units on a scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Irritant/Allergic Contact Dermatitis
Week 1
|
0.04 units on a scale
Standard Deviation 0.20
|
0.04 units on a scale
Standard Deviation 0.20
|
|
Irritant/Allergic Contact Dermatitis
Week 2
|
0.04 units on a scale
Standard Deviation 0.20
|
0.04 units on a scale
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Weeks 5 and 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Erythema (Redness)
Week 8
|
0.19 units on a scale
Standard Deviation 0.50
|
—
|
|
Erythema (Redness)
Week 5
|
0.22 units on a scale
Standard Deviation 0.42
|
—
|
SECONDARY outcome
Timeframe: Weeks 5 and 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Skin Dryness
Week 5
|
0.20 units on a scale
Standard Deviation 0.46
|
—
|
|
Skin Dryness
Week 8
|
0.04 units on a scale
Standard Deviation 0.29
|
—
|
SECONDARY outcome
Timeframe: Weeks 5 and 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Skin Peeling
Week 5
|
0.13 units on a scale
Standard Deviation 0.40
|
—
|
|
Skin Peeling
Week 8
|
0.06 units on a scale
Standard Deviation 0.25
|
—
|
SECONDARY outcome
Timeframe: Weeks 5 and 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Irritant/Allergic Contact Dermatitis
Week 5
|
0.00 units on a scale
Standard Deviation 0.00
|
—
|
|
Irritant/Allergic Contact Dermatitis
Week 8
|
0.00 units on a scale
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 8Population: 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.
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Investigators Static Global Assessment
Baseline
|
2.77 units on a scale
Standard Deviation 0.56
|
—
|
|
Investigators Static Global Assessment
Week 5
|
1.89 units on a scale
Standard Deviation 0.75
|
—
|
|
Investigators Static Global Assessment
Week 8
|
1.62 units on a scale
Standard Deviation 0.92
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5 and 8Population: ITT
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Total Acne Lesion Counts
Baseline
|
39.06 Acne Lesions
Standard Deviation 12.95
|
—
|
|
Total Acne Lesion Counts
Week 5
|
15.96 Acne Lesions
Standard Deviation 10.37
|
—
|
|
Total Acne Lesion Counts
Week 8
|
13.77 Acne Lesions
Standard Deviation 11.50
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5 and 8Population: ITT
Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Inflammatory Acne Lesion Counts
Baseline
|
14.23 Acne Lesions
Standard Deviation 9.06
|
—
|
|
Inflammatory Acne Lesion Counts
Week 5
|
4.60 Acne Lesions
Standard Deviation 3.93
|
—
|
|
Inflammatory Acne Lesion Counts
Week 8
|
4.26 Acne Lesions
Standard Deviation 5.84
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5 and 8Population: ITT
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Non-inflammatory Acne Lesion Counts
Baseline
|
24.83 Acne Lesions
Standard Deviation 12.84
|
—
|
|
Non-inflammatory Acne Lesion Counts
Week 5
|
11.36 Acne Lesions
Standard Deviation 7.89
|
—
|
|
Non-inflammatory Acne Lesion Counts
Week 8
|
9.51 Acne Lesions
Standard Deviation 8.53
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2 and 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
Baseline
|
20.91 Units on a scale
Standard Deviation 15.73
|
—
|
|
Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
Week 2
|
21.58 Units on a scale
Standard Deviation 14.17
|
—
|
|
Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
Week 8
|
13.75 Units on a scale
Standard Deviation 14.03
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2 and 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Quality of Life Questionnaire - Emotional Domain
Baseline
|
25.32 Units on a scale
Standard Deviation 19.73
|
—
|
|
Quality of Life Questionnaire - Emotional Domain
Week 8
|
16.42 Units on a scale
Standard Deviation 19.08
|
—
|
|
Quality of Life Questionnaire - Emotional Domain
Week 2
|
19.38 Units on a scale
Standard Deviation 18.68
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2 and 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Quality of Life Questionnaire - Functional Domain
Baseline
|
8.59 Units on a scale
Standard Deviation 13.98
|
—
|
|
Quality of Life Questionnaire - Functional Domain
Week 2
|
6.30 Units on a scale
Standard Deviation 11.77
|
—
|
|
Quality of Life Questionnaire - Functional Domain
Week 8
|
5.19 Units on a scale
Standard Deviation 11.78
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2 and 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Quality of Life Questionnaire - Global Score
Week 2
|
6.30 Units on a scale
Standard Deviation 11.77
|
—
|
|
Quality of Life Questionnaire - Global Score
Week 8
|
5.19 Units on a scale
Standard Deviation 11.78
|
—
|
|
Quality of Life Questionnaire - Global Score
Baseline
|
8.59 Units on a scale
Standard Deviation 13.98
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
Week 1
|
1.09 Units on a scale
Standard Deviation 1.18
|
1.72 Units on a scale
Standard Deviation 1.21
|
|
Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
Week 2
|
0.72 Units on a scale
Standard Deviation 0.86
|
1.15 Units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8
|
0.77 Units on a scale
Standard Deviation 1.09
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
Week 1
|
1.30 Units on a scale
Standard Deviation 1.14
|
1.81 Units on a scale
Standard Deviation 1.14
|
|
Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
Week 2
|
1.00 Units on a scale
Standard Deviation 0.87
|
1.41 Units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8
|
0.64 Units on a scale
Standard Deviation 0.97
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
Week 1
|
0.91 Units on a scale
Standard Deviation 1.23
|
1.68 Units on a scale
Standard Deviation 1.20
|
|
Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
Week 2
|
0.72 Units on a scale
Standard Deviation 0.89
|
1.30 Units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8
|
0.36 Units on a scale
Standard Deviation 0.76
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
Week 1
|
0.64 Units on a scale
Standard Deviation 1.11
|
1.02 Units on a scale
Standard Deviation 1.34
|
|
Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
Week 2
|
0.72 Units on a scale
Standard Deviation 0.96
|
0.93 Units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8
|
0.26 Units on a scale
Standard Deviation 0.49
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
Week 1
|
0.79 Units on a scale
Standard Deviation 1.18
|
1.43 Units on a scale
Standard Deviation 1.41
|
|
Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
Week 2
|
0.59 Units on a scale
Standard Deviation 0.69
|
1.04 Units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8
|
0.45 Units on a scale
Standard Deviation 0.83
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2
Week 1
|
1.30 Units on a scale
Standard Deviation 0.51
|
1.32 Units on a scale
Standard Deviation 0.56
|
|
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2
Week 2
|
1.35 Units on a scale
Standard Deviation 0.53
|
1.39 Units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8
|
1.26 Units on a scale
Standard Deviation 0.44
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
Week 1
|
2.81 Units on a scale
Standard Deviation 0.88
|
3.15 Units on a scale
Standard Deviation 1.08
|
|
Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
Week 2
|
2.39 Units on a scale
Standard Deviation 0.93
|
2.67 Units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8
|
1.83 Units on a scale
Standard Deviation 0.92
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT. Data are presented for only those participants completing the questionnaire.
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.
Outcome measures
| Measure |
Clindoxyl Gel
n=47 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Week 1, Clindoxyl Gel, n=47
|
30 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Week 1, Epiduo Gel, n=47
|
15 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Week 1, Both Treatments Equally, n=47
|
2 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Week 2, Epiduo Gel, n=46
|
16 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Week 2, Clindoxyl Gel, n=46
|
29 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Week 2, Both Treatments Equally, n=46
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8
|
1.63 Units on a scale
Standard Deviation 1.08
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
Week 1
|
1.87 Units on a scale
Standard Deviation 0.68
|
2.04 Units on a scale
Standard Deviation 0.78
|
|
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
Week 2
|
1.85 Units on a scale
Standard Deviation 0.84
|
2.00 Units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8
|
1.53 Units on a scale
Standard Deviation 0.65
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
Week 1
|
1.91 Units on a scale
Standard Deviation 0.28
|
1.91 Units on a scale
Standard Deviation 0.28
|
|
Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
Week 2
|
1.85 Units on a scale
Standard Deviation 0.42
|
1.85 Units on a scale
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Compliance at Week 8
Yes
|
43 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Compliance at Week 8
No
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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?
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Week 1 - Yes
|
16 Participants
|
12 Participants
|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Week 1 - No
|
31 Participants
|
35 Participants
|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Week 2 - Yes
|
14 Participants
|
11 Participants
|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Week 2 - No
|
32 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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?
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
Yes
|
28 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
No
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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?
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Week 1 - Yes
|
44 Participants
|
26 Participants
|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Week 1 - No
|
3 Participants
|
21 Participants
|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Week 2 - Yes
|
39 Participants
|
32 Participants
|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Week 2 - No
|
7 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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?
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
Yes
|
41 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
No
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2
Week 1
|
2.23 Units on a scale
Standard Deviation 1.24
|
2.31 Units on a scale
Standard Deviation 1.38
|
|
Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2
Week 2
|
1.75 Units on a scale
Standard Deviation 0.93
|
1.75 Units on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8
|
1.69 Units on a scale
Standard Deviation 0.87
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
n=48 Participants
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
Week 1
|
2.09 Units on a scale
Standard Deviation 0.69
|
2.23 Units on a scale
Standard Deviation 0.87
|
|
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
Week 2
|
1.76 Units on a scale
Standard Deviation 0.77
|
1.98 Units on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Clindoxyl Gel
n=48 Participants
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
Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8
|
1.61 Units on a scale
Standard Deviation 0.98
|
—
|
Adverse Events
Clindoxyl and Epiduo Gels
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clindoxyl and Epiduo Gels
n=48 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Application site irritation
|
75.0%
36/48 • Number of events 36 • Baseline through Week 8.
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.
|
|
Skin and subcutaneous tissue disorders
Application site dryness
|
39.6%
19/48 • Number of events 19 • Baseline through Week 8.
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.
|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
22.9%
11/48 • Number of events 11 • Baseline through Week 8.
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.
|
|
Skin and subcutaneous tissue disorders
Application site exfoliation
|
20.8%
10/48 • Number of events 10 • Baseline through Week 8.
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.
|
|
Skin and subcutaneous tissue disorders
Drug intolerance
|
8.3%
4/48 • Number of events 4 • Baseline through Week 8.
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER