Trial Outcomes & Findings for Study of Two Different 10.0% Benzoyl Peroxide Creams for Mild to Moderate Acne Vulgaris (NCT NCT00787943)
NCT ID: NCT00787943
Last Updated: 2015-05-01
Results Overview
Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
4 Weeks
Results posted on
2015-05-01
Participant Flow
Participants were recruited from the clinic, as well as advertising in the Department of Dermatology.
Participant milestones
| Measure |
All Study Participants
Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Two Different 10.0% Benzoyl Peroxide Creams for Mild to Moderate Acne Vulgaris
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 WeeksPopulation: Papules and pustules were analyzed on the left and right side of the face for each of the 10 subjects. Analysis was per protocol with intention to treat.
Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.
Outcome measures
| Measure |
Papules: Benzoyl Peroxide 10.0% Cream Formulation #1
n=10 Participants
Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
|
Pustules: Benzoyl Peroxide 10.0% Cream Formulation #1
n=10 Participants
Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
|
Papules: Benzoyl Peroxide 10.0% Cream Formulation #2
n=10 Participants
Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
|
Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2
n=10 Participants
Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
|
|---|---|---|---|---|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 10 Day 0
|
13 Lesions
|
2 Lesions
|
13 Lesions
|
4 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 10 Day 2
|
15 Lesions
|
0 Lesions
|
18 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 9 Day 28
|
13 Lesions
|
0 Lesions
|
11 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 1 Day 0
|
6 Lesions
|
3 Lesions
|
10 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 1 Day 2
|
1 Lesions
|
0 Lesions
|
5 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 1 Day 7
|
1 Lesions
|
0 Lesions
|
1 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 1 Day 28
|
6 Lesions
|
1 Lesions
|
4 Lesions
|
2 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 2 Day 0
|
14 Lesions
|
2 Lesions
|
7 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 2 Day 2
|
15 Lesions
|
1 Lesions
|
12 Lesions
|
2 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 2 Day 7
|
7 Lesions
|
0 Lesions
|
4 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 2 Day 28
|
7 Lesions
|
0 Lesions
|
8 Lesions
|
9 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 3 Day 0
|
7 Lesions
|
0 Lesions
|
9 Lesions
|
6 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 3 Day 2
|
8 Lesions
|
0 Lesions
|
7 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 3 Day 7
|
5 Lesions
|
3 Lesions
|
11 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 3 Day 28
|
8 Lesions
|
0 Lesions
|
0 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 4 Day 0
|
14 Lesions
|
4 Lesions
|
6 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 4 Day 2
|
20 Lesions
|
1 Lesions
|
4 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 4 Day 7
|
21 Lesions
|
0 Lesions
|
7 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 4 Day 28
|
10 Lesions
|
1 Lesions
|
9 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 5 Day 0
|
23 Lesions
|
1 Lesions
|
23 Lesions
|
2 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 5 Day 2
|
26 Lesions
|
18 Lesions
|
28 Lesions
|
21 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 5 Day 7
|
31 Lesions
|
0 Lesions
|
31 Lesions
|
4 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 5 Day 28
|
26 Lesions
|
1 Lesions
|
29 Lesions
|
2 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 6 Day 0
|
22 Lesions
|
2 Lesions
|
6 Lesions
|
3 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 6 Day 2
|
14 Lesions
|
0 Lesions
|
6 Lesions
|
2 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 6 Day 7
|
10 Lesions
|
1 Lesions
|
10 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 6 Day 28
|
12 Lesions
|
1 Lesions
|
11 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 7 Day 0
|
34 Lesions
|
6 Lesions
|
30 Lesions
|
5 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 7 Day 2
|
47 Lesions
|
3 Lesions
|
34 Lesions
|
7 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 7 Day 7
|
46 Lesions
|
3 Lesions
|
53 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 7 Day 28
|
35 Lesions
|
6 Lesions
|
33 Lesions
|
4 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 8 Day 0
|
9 Lesions
|
1 Lesions
|
7 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 8 Day 2
|
11 Lesions
|
0 Lesions
|
5 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 8 Day 7
|
10 Lesions
|
0 Lesions
|
3 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 8 Day 28
|
6 Lesions
|
0 Lesions
|
7 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 9 Day 0
|
17 Lesions
|
1 Lesions
|
19 Lesions
|
1 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 9 Day 2
|
21 Lesions
|
0 Lesions
|
19 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 9 Day 7
|
22 Lesions
|
0 Lesions
|
14 Lesions
|
0 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 10 Day 7
|
13 Lesions
|
1 Lesions
|
7 Lesions
|
2 Lesions
|
|
Number of Inflammatory Lesions (Papules and Pustules)
Subject 10 Day 28
|
6 Lesions
|
1 Lesions
|
9 Lesions
|
0 Lesions
|
Adverse Events
Benzoyl Peroxide 10.0% Cream Formulation #1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Benzoyl Peroxide 10.0% Cream: Formulation #2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Benzoyl Peroxide 10.0% Cream Formulation #1
n=10 participants at risk
Formulation #1 applied to one side of the face by all 10 subjects.
|
Benzoyl Peroxide 10.0% Cream: Formulation #2
n=10 participants at risk
Formulation #2 applied to one side of the face by all 10 subjects.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Burning/Stinging
|
80.0%
8/10 • Number of events 40 • 4 weeks
|
80.0%
8/10 • Number of events 40 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place