Trial Outcomes & Findings for A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products (NCT NCT01313728)
NCT ID: NCT01313728
Last Updated: 2012-02-15
Results Overview
Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).
COMPLETED
PHASE4
26 participants
Baseline to 2 Weeks
2012-02-15
Participant Flow
Participant milestones
| Measure |
Overall Study
This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
|
|---|---|
|
Informed Consent to Baseline
STARTED
|
26
|
|
Informed Consent to Baseline
COMPLETED
|
25
|
|
Informed Consent to Baseline
NOT COMPLETED
|
1
|
|
Baseline to Completion
STARTED
|
25
|
|
Baseline to Completion
COMPLETED
|
25
|
|
Baseline to Completion
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Overall Study
This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
|
|---|---|
|
Informed Consent to Baseline
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products
Baseline characteristics by cohort
| Measure |
Overall Study
n=25 Participants
This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
Fitzpatrick Score
Type I
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Score
Type II
|
10 Participants
n=5 Participants
|
|
Fitzpatrick Score
Type III
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 WeeksPopulation: Intention to Treat (ITT)
Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).
Outcome measures
| Measure |
Dapsone Gel + Tretinoin Gel
n=25 Participants
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
|
Tretinoin Gel Alone
n=25 Participants
Tretinoin gel applied once daily to the assigned side of the face
|
|---|---|---|
|
Expert Grader Assessment - Erythema
Day 0 = Baseline
|
0.0 Scores on a Scale
|
0.0 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 1
|
0.4 Scores on a Scale
|
2.0 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 2
|
0.4 Scores on a Scale
|
2.0 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 3
|
1.6 Scores on a Scale
|
6.4 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 4
|
6.8 Scores on a Scale
|
7.6 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 7
|
9.7 Scores on a Scale
|
17.1 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 8
|
10.8 Scores on a Scale
|
20.9 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 9
|
10.6 Scores on a Scale
|
20.1 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 10
|
11.6 Scores on a Scale
|
20.4 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 11
|
11.6 Scores on a Scale
|
23.0 Scores on a Scale
|
|
Expert Grader Assessment - Erythema
Day 14
|
16.6 Scores on a Scale
|
19.5 Scores on a Scale
|
PRIMARY outcome
Timeframe: Baseline to 2 WeeksPopulation: Intention to Treat (ITT)
Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).
Outcome measures
| Measure |
Dapsone Gel + Tretinoin Gel
n=25 Participants
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
|
Tretinoin Gel Alone
n=25 Participants
Tretinoin gel applied once daily to the assigned side of the face
|
|---|---|---|
|
Expert Grader Assessment - Dryness
Day 0 = Baseline
|
0.0 Scores on a Scale
|
0.0 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 1
|
0.6 Scores on a Scale
|
1.8 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 2
|
1.7 Scores on a Scale
|
2.5 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 3
|
3.5 Scores on a Scale
|
8.1 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 4
|
12.6 Scores on a Scale
|
14.2 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 7
|
14.8 Scores on a Scale
|
19.9 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 8
|
18.5 Scores on a Scale
|
25.6 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 9
|
13.6 Scores on a Scale
|
23.0 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 10
|
20.4 Scores on a Scale
|
37.6 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 11
|
17.3 Scores on a Scale
|
37.6 Scores on a Scale
|
|
Expert Grader Assessment - Dryness
Day 14
|
23.5 Scores on a Scale
|
28.3 Scores on a Scale
|
SECONDARY outcome
Timeframe: Baseline to 2 WeeksPopulation: Intention to Treat (ITT)
Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Outcome measures
| Measure |
Dapsone Gel + Tretinoin Gel
n=25 Participants
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
|
Tretinoin Gel Alone
n=25 Participants
Tretinoin gel applied once daily to the assigned side of the face
|
|---|---|---|
|
Subject Assessment - Burning/Stinging
Day 0 = Baseline
|
1.0 Scores on a Scale
|
0.0 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 1
|
2.6 Scores on a Scale
|
1.6 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 2
|
1.8 Scores on a Scale
|
2.6 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 3
|
6.6 Scores on a Scale
|
5.5 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 4
|
8.7 Scores on a Scale
|
12.2 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 7
|
7.5 Scores on a Scale
|
9.5 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 8
|
14.5 Scores on a Scale
|
17.2 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 9
|
9.6 Scores on a Scale
|
20.2 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 10
|
11.6 Scores on a Scale
|
25.9 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 11
|
10.6 Scores on a Scale
|
25.9 Scores on a Scale
|
|
Subject Assessment - Burning/Stinging
Day 14
|
14.6 Scores on a Scale
|
23.2 Scores on a Scale
|
SECONDARY outcome
Timeframe: Baseline to 2 WeeksPopulation: Intention to Treat (ITT)
Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Outcome measures
| Measure |
Dapsone Gel + Tretinoin Gel
n=25 Participants
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
|
Tretinoin Gel Alone
n=25 Participants
Tretinoin gel applied once daily to the assigned side of the face
|
|---|---|---|
|
Subject Assessment - Itching
Day 11
|
8.6 Scores on a Scale
|
13.4 Scores on a Scale
|
|
Subject Assessment - Itching
Day 14
|
7.6 Scores on a Scale
|
9.4 Scores on a Scale
|
|
Subject Assessment - Itching
Day 9
|
5.6 Scores on a Scale
|
12.4 Scores on a Scale
|
|
Subject Assessment - Itching
Day 10
|
7.6 Scores on a Scale
|
17.1 Scores on a Scale
|
|
Subject Assessment - Itching
Day 0 = Baseline
|
0.0 Scores on a Scale
|
0.0 Scores on a Scale
|
|
Subject Assessment - Itching
Day 1
|
1.6 Scores on a Scale
|
2.8 Scores on a Scale
|
|
Subject Assessment - Itching
Day 2
|
0.5 Scores on a Scale
|
1.9 Scores on a Scale
|
|
Subject Assessment - Itching
Day 3
|
0.6 Scores on a Scale
|
1.8 Scores on a Scale
|
|
Subject Assessment - Itching
Day 4
|
2.6 Scores on a Scale
|
2.8 Scores on a Scale
|
|
Subject Assessment - Itching
Day 7
|
3.6 Scores on a Scale
|
7.6 Scores on a Scale
|
|
Subject Assessment - Itching
Day 8
|
5.6 Scores on a Scale
|
12.4 Scores on a Scale
|
SECONDARY outcome
Timeframe: Baseline to 2 WeeksPopulation: Intention to Treat (ITT)
Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Outcome measures
| Measure |
Dapsone Gel + Tretinoin Gel
n=25 Participants
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
|
Tretinoin Gel Alone
n=25 Participants
Tretinoin gel applied once daily to the assigned side of the face
|
|---|---|---|
|
Subject Assessment - Tightness
Day 0 = Baseline
|
0.0 Scores on a Scale
|
0.0 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 1
|
1.5 Scores on a Scale
|
1.8 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 2
|
1.5 Scores on a Scale
|
2.9 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 3
|
2.6 Scores on a Scale
|
4.7 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 4
|
5.7 Scores on a Scale
|
8.5 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 7
|
8.6 Scores on a Scale
|
12.5 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 8
|
12.5 Scores on a Scale
|
19.0 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 9
|
11.6 Scores on a Scale
|
17.2 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 10
|
12.5 Scores on a Scale
|
20.0 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 11
|
9.6 Scores on a Scale
|
15.3 Scores on a Scale
|
|
Subject Assessment - Tightness
Day 14
|
10.5 Scores on a Scale
|
14.4 Scores on a Scale
|
SECONDARY outcome
Timeframe: Baseline to 2 WeeksAll interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).
Outcome measures
| Measure |
Dapsone Gel + Tretinoin Gel
n=25 Participants
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
|
Tretinoin Gel Alone
n=25 Participants
Tretinoin gel applied once daily to the assigned side of the face
|
|---|---|---|
|
Facial Tolerance
Day 0 = Baseline
|
1.0 Scores on a Scale
|
0.0 Scores on a Scale
|
|
Facial Tolerance
Day 1
|
6.7 Scores on a Scale
|
10.0 Scores on a Scale
|
|
Facial Tolerance
Day 2
|
5.9 Scores on a Scale
|
11.9 Scores on a Scale
|
|
Facial Tolerance
Day 3
|
14.9 Scores on a Scale
|
26.5 Scores on a Scale
|
|
Facial Tolerance
Day 4
|
36.4 Scores on a Scale
|
45.3 Scores on a Scale
|
|
Facial Tolerance
Day 7
|
44.2 Scores on a Scale
|
66.6 Scores on a Scale
|
|
Facial Tolerance
Day 8
|
61.9 Scores on a Scale
|
95.1 Scores on a Scale
|
|
Facial Tolerance
Day 9
|
51.0 Scores on a Scale
|
93.9 Scores on a Scale
|
|
Facial Tolerance
Day 10
|
63.7 Scores on a Scale
|
124.6 Scores on a Scale
|
|
Facial Tolerance
Day 11
|
57.7 Scores on a Scale
|
115.2 Scores on a Scale
|
|
Facial Tolerance
Day 14
|
72.8 Scores on a Scale
|
94.8 Scores on a Scale
|
Adverse Events
Overall Study
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Study
n=25 participants at risk
This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Irritation
|
8.0%
2/25
|
Additional Information
David Lineberry, Associate Director, Clinical Operations
Valeant Pharmaceuticals International Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60