Trial Outcomes & Findings for Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications (NCT NCT00964366)
NCT ID: NCT00964366
Last Updated: 2017-05-30
Results Overview
Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
53 participants
Primary outcome timeframe
2 Weeks
Results posted on
2017-05-30
Participant Flow
Clinical research center. Subject recruitment occurred from July 16, 2009 to Aug. 11, 2009
Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.
Participant milestones
| Measure |
Clindamycin and BPO Gel
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Dapsone Gel
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
25
|
|
Overall Study
COMPLETED
|
27
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Clindamycin and BPO Gel
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Dapsone Gel
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
|---|---|---|
|
Overall Study
Did not qualify at Day 1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications
Baseline characteristics by cohort
| Measure |
Clindamycin and BPO Gel
n=28 Participants
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Dapsone Gel
n=25 Participants
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 WeeksPopulation: ITT
Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion
Outcome measures
| Measure |
Clindamycin and BPO Gel
n=27 Participants
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Dapsone Gel
n=25 Participants
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
|---|---|---|
|
Skin Erythema (Redness)
Day 1
|
1.26 Units on a scale
Standard Deviation .76
|
1.34 Units on a scale
Standard Deviation .81
|
|
Skin Erythema (Redness)
Baseline
|
1.06 Units on a scale
Standard Deviation 0.79
|
1.18 Units on a scale
Standard Deviation 0.63
|
|
Skin Erythema (Redness)
Day 2
|
1.55 Units on a scale
Standard Deviation .84
|
1.33 Units on a scale
Standard Deviation .85
|
|
Skin Erythema (Redness)
Day 3
|
1.32 Units on a scale
Standard Deviation .63
|
1.50 Units on a scale
Standard Deviation .59
|
|
Skin Erythema (Redness)
Day 6
|
1.30 Units on a scale
Standard Deviation .75
|
1.65 Units on a scale
Standard Deviation .92
|
|
Skin Erythema (Redness)
Day 7
|
1.64 Units on a scale
Standard Deviation 1.02
|
1.53 Units on a scale
Standard Deviation .82
|
|
Skin Erythema (Redness)
Day 8
|
1.80 Units on a scale
Standard Deviation .80
|
1.60 Units on a scale
Standard Deviation .93
|
|
Skin Erythema (Redness)
Day 9
|
1.67 Units on a scale
Standard Deviation .95
|
1.45 Units on a scale
Standard Deviation .89
|
|
Skin Erythema (Redness)
Day 10
|
1.81 Units on a scale
Standard Deviation .89
|
1.85 Units on a scale
Standard Deviation 1.13
|
|
Skin Erythema (Redness)
Day 13
|
1.52 Units on a scale
Standard Deviation 1.20
|
1.65 Units on a scale
Standard Deviation 1.05
|
|
Skin Erythema (Redness)
Day 14
|
2.10 Units on a scale
Standard Deviation 1.09
|
1.90 Units on a scale
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: Baseline, Day 1through Day 14Population: ITT
The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Clindamycin and BPO Gel
n=27 Participants
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Dapsone Gel
n=25 Participants
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
|---|---|---|
|
Skin Dryness
Day 14
|
0.55 Units on a scale
Standard Deviation 1.11
|
0.12 Units on a scale
Standard Deviation 0.28
|
|
Skin Dryness
Baseline
|
0.11 Units on a scale
Standard Deviation 0.32
|
0.12 Units on a scale
Standard Deviation 0.33
|
|
Skin Dryness
Day 1
|
0.04 Units on a scale
Standard Deviation 0.05
|
0.28 Units on a scale
Standard Deviation 0.71
|
|
Skin Dryness
Day 2
|
0.10 Units on a scale
Standard Deviation 0.26
|
0.23 Units on a scale
Standard Deviation 0.57
|
|
Skin Dryness
Day 3
|
0.16 Units on a scale
Standard Deviation 0.32
|
0.48 Units on a scale
Standard Deviation 0.81
|
|
Skin Dryness
Day 6
|
0.27 Units on a scale
Standard Deviation 0.79
|
0.37 Units on a scale
Standard Deviation 0.64
|
|
Skin Dryness
Day 7
|
0.21 Units on a scale
Standard Deviation 0.45
|
0.23 Units on a scale
Standard Deviation 0.47
|
|
Skin Dryness
Day 8
|
0.54 Units on a scale
Standard Deviation 1.03
|
0.17 Units on a scale
Standard Deviation 0.35
|
|
Skin Dryness
Day 9
|
0.5 Units on a scale
Standard Deviation 1.04
|
0.10 Units on a scale
Standard Deviation 0.20
|
|
Skin Dryness
Day 10
|
0.57 Units on a scale
Standard Deviation 0.91
|
0.15 Units on a scale
Standard Deviation 0.44
|
|
Skin Dryness
Day 13
|
0.57 Units on a scale
Standard Deviation 1.24
|
0.17 Units on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: 2 WeeksTo assess skin moisture and hydration using transepidermal water loss (TEWL). These tables record the data obtained for each panelist at Baseline, and on Days 3, 7 and 14 or upon early termination of site(s), if applicable. Results are measured on a continuous scale.
Outcome measures
| Measure |
Clindamycin and BPO Gel
n=27 Participants
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Dapsone Gel
n=25 Participants
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
|---|---|---|
|
Transepidermal Water Loss (TEWL)
Baseline
|
10.29 TEWL rates (gm/m2/hr)
Standard Deviation 3.06
|
10.4 TEWL rates (gm/m2/hr)
Standard Deviation 2.93
|
|
Transepidermal Water Loss (TEWL)
Day 3
|
12.34 TEWL rates (gm/m2/hr)
Standard Deviation 4.80
|
11.21 TEWL rates (gm/m2/hr)
Standard Deviation 3.26
|
|
Transepidermal Water Loss (TEWL)
Day 7
|
14.39 TEWL rates (gm/m2/hr)
Standard Deviation 3.73
|
11.53 TEWL rates (gm/m2/hr)
Standard Deviation 3.09
|
|
Transepidermal Water Loss (TEWL)
Day 14
|
13.88 TEWL rates (gm/m2/hr)
Standard Deviation 3.70
|
11.26 TEWL rates (gm/m2/hr)
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: ITT
To sample the skin surface, the sebum collector strips are applied to the skin sites for 10 seconds. Once removed, these samples will be immediately measured for the amount of sebum on the strip using the tape analyzer. The amount of sebum production was measured as the amount of sebum collected on a tape applied to the skin for 10 seconds and then converted to 1 of 10 incremental levels. Sebum production was measured in increments of 0 (minimum value) to 10 (maximum value). The higher the number, the greater amount of sebum produced.
Outcome measures
| Measure |
Clindamycin and BPO Gel
n=27 Participants
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Dapsone Gel
n=25 Participants
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
|---|---|---|
|
Sebum Measurements
Baseline
|
1.72 units on a scale
Standard Deviation 1.31
|
2.18 units on a scale
Standard Deviation 1.73
|
|
Sebum Measurements
Day 3
|
1.52 units on a scale
Standard Deviation 1.01
|
1.72 units on a scale
Standard Deviation 1.11
|
|
Sebum Measurements
Day 7
|
2.65 units on a scale
Standard Deviation 2.05
|
3.33 units on a scale
Standard Deviation 2.43
|
|
Sebum Measurements
Day 14
|
2.35 units on a scale
Standard Deviation 2.01
|
2.38 units on a scale
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: ITT
Evaluation of Skin Hydration using electrical conductance measurements,on weekdays during 14 days of treatment. The value recorded which is expressed in units of microsiemens represents the AC conductance 2-3 seconds after placing the spring-loaded probe tip to the sample site.
Outcome measures
| Measure |
Clindamycin and BPO Gel
n=27 Participants
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Dapsone Gel
n=25 Participants
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
|---|---|---|
|
Skin Hydration
Baseline
|
499.51 Microsiemens
Standard Deviation 124.27
|
448.31 Microsiemens
Standard Deviation 149.26
|
|
Skin Hydration
4 hours post 1st treatment
|
430.38 Microsiemens
Standard Deviation 156.71
|
404.68 Microsiemens
Standard Deviation 170.45
|
|
Skin Hydration
Day 3
|
614.73 Microsiemens
Standard Deviation 144.64
|
511.63 Microsiemens
Standard Deviation 163.97
|
|
Skin Hydration
Day 7
|
460.65 Microsiemens
Standard Deviation 169.03
|
456.73 Microsiemens
Standard Deviation 173.07
|
|
Skin Hydration
Day 14
|
477.80 Microsiemens
Standard Deviation 173.40
|
471.13 Microsiemens
Standard Deviation 194.77
|
Adverse Events
Clindamycin and BPO Gel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dapsone Gel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clindamycin and BPO Gel
n=27 participants at risk
Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
Dapsone Gel
n=25 participants at risk
Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1 • 14 days.
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
4.0%
1/25 • Number of events 1 • 14 days.
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Infections and infestations
Infection
|
3.7%
1/27 • Number of events 1 • 14 days.
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
4.0%
1/25 • Number of events 1 • 14 days.
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 888-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60