Trial Outcomes & Findings for Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris (NCT NCT00558831)
NCT ID: NCT00558831
Last Updated: 2017-09-26
Results Overview
-1=worse 0=unchanged * 1=mild improvement * 2=moderate improvement * 3=clear
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
baseline and 1 month
Results posted on
2017-09-26
Participant Flow
Participants in this study were patients clinically diagnosed with acne vulgaris. Participants will be recruited from the clinic. Patients were 18 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face.
Participant milestones
| Measure |
Subjects
Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Subjects
Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Subjects
n=11 Participants
Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 month-1=worse 0=unchanged * 1=mild improvement * 2=moderate improvement * 3=clear
Outcome measures
| Measure |
Benzoyl Peroxide 2.5% Cream
n=10 Participants
|
Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion
n=10 Participants
|
|---|---|---|
|
Subject Reported Change From Baseline Scale
-1=Worse
|
0 Participants
|
0 Participants
|
|
Subject Reported Change From Baseline Scale
0=Unchanged
|
7 Participants
|
6 Participants
|
|
Subject Reported Change From Baseline Scale
1=Mild Improvement
|
1 Participants
|
1 Participants
|
|
Subject Reported Change From Baseline Scale
2=Moderate Improvement
|
1 Participants
|
2 Participants
|
|
Subject Reported Change From Baseline Scale
3=Clear
|
1 Participants
|
1 Participants
|
Adverse Events
Benzoyl Peroxide 2.5%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Benzoyl Peroxide 2.5%
n=11 participants at risk
|
Benzoyl Peroxide 2.5% Plus Moisturizing Lotion
n=11 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dryness
|
54.5%
6/11 • Number of events 10 • 1 month
|
18.2%
2/11 • Number of events 3 • 1 month
|
|
Skin and subcutaneous tissue disorders
Burning
|
36.4%
4/11 • Number of events 4 • 1 month
|
27.3%
3/11 • Number of events 3 • 1 month
|
|
Skin and subcutaneous tissue disorders
Itching
|
9.1%
1/11 • Number of events 1 • 1 month
|
9.1%
1/11 • Number of events 1 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place