Acne Vulgaris
Conditions
Keywords
Acne
Brief summary
The purpose of this study is to compare the efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for the treatment of acne vulgaris.
Detailed description
The purpose of this study is to compare the safety and efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for mild to moderate acne vulgaris.
Interventions
DRUGBenzoyl Peroxide
Benzoyl Peroxide 2.5%
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy male or female subjects who are 18 to 35 years of age. 2. Subjects are in good health and are free of any other facial skin disorders that may interfere with acne study assessments. 3. Subjects have the willingness and ability to understand and provide informed assent/consent to participate in the study and are able to communicate with the investigator. Subjects are willing and able to follow all study directions and to commit to all follow-up visits for the duration of the study. In addition, subjects must be willing to accept the restrictions of the study. 4. A minimum of 2 but no more than 30 inflammatory lesions (papules and pustules), relatively symmetrical in appearance on both sides of the face and a minimum of 2 but not more than 100 non-inflammatory lesions (open comedones and closed comedones) relatively symmetrical in appearance on both sides of the face. 5. Ongoing oral medications (other than those specifically for acne) are acceptable provided subjects are on a stable regimen throughout the study and provided the medications are determined likely to not interfere with study assessments. 6. Subjects will not use medicated cosmetics and/or soaps (including soaps containing antibacterial agents such as benzoyl peroxide, keratolytic agents such as salicylic acid, skin fresheners/astringents or aftershave lotions) for the duration of the study. 7. Subjects who agree not use any other acne treatment (including prescription and non-prescription medications) on the test site for the duration of the study. 8. Subjects who agree not to change facial cosmetic products during the study. 9. Subjects who agree to only use sunscreen/sunblock agents that are labeled as non-comedogenic.
Exclusion criteria
1. Subjects or parents of subjects who are unable to understand the protocol or to give informed consent/assent. 2. Subjects with mental illness. 3. Subjects with no inflammatory acne. 4. Subjects with any acne cysts or nodules. 5. Subjects with acne conglobata, acne fulminans, secondary acne (e.g. Chloracne, drug-induced acne), or any acne requiring systemic treatment. 6. Subjects with excessive facial hair that may interfere with study assessments. 7. Subjects with other facial skin disorders that may interfere with study assessments. 8. Subjects with a history of skin cancer or actinic keratosis. 9. Subjects who have used tanning devices within one week prior to baseline study visit. 10. Subjects who have applied any topical products (e.g. emollients, sunscreens) or any cosmetics to the face at least one hour prior to study assessments. 11. Use of hormonal oral contraceptives for acne control or for less than 6 months prior to study baseline. 12. Subjects with known allergies, a history of, or sensitive to salicylic acid, benzoyl peroxide or any of the test article components. 13. Subjects using topical or systemic medication within 14 days before the study entry, which could interfere with study assessments. This includes but is not limited to the following: anti-inflammatory drugs (e.g. topical and systemic corticosteroids and systemic antihistamines), anti-acne drugs, topical and oral retinoids, topical antibacterial agents to the face, and any immunosuppressive drugs. Ongoing oral medications not expected to interfere with study assessments are allowed if the subject is on a stable regimen. 14. Subjects who are currently enrolled in another clinical investigation or have been enrolled in an acne trial within a period of 30 days prior to enrollment in this study. 15. Subjects who are pregnant or nursing. 16. Subjects who require electrolysis, waxing, or depilatories on the face during conduct of the study. 17. Subjects viewed by the investigator as not being able to complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Change From Baseline Scale | baseline and 1 month | -1=worse 0=unchanged * 1=mild improvement * 2=moderate improvement * 3=clear |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 6 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Subject Reported Change From Baseline Scale
-1=worse 0=unchanged * 1=mild improvement * 2=moderate improvement * 3=clear
Time frame: baseline and 1 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benzoyl Peroxide 2.5% Cream | Subject Reported Change From Baseline Scale | 0=Unchanged | 7 Participants |
| Benzoyl Peroxide 2.5% Cream | Subject Reported Change From Baseline Scale | 2=Moderate Improvement | 1 Participants |
| Benzoyl Peroxide 2.5% Cream | Subject Reported Change From Baseline Scale | 1=Mild Improvement | 1 Participants |
| Benzoyl Peroxide 2.5% Cream | Subject Reported Change From Baseline Scale | 3=Clear | 1 Participants |
| Benzoyl Peroxide 2.5% Cream | Subject Reported Change From Baseline Scale | -1=Worse | 0 Participants |
| Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion | Subject Reported Change From Baseline Scale | 3=Clear | 1 Participants |
| Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion | Subject Reported Change From Baseline Scale | -1=Worse | 0 Participants |
| Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion | Subject Reported Change From Baseline Scale | 0=Unchanged | 6 Participants |
| Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion | Subject Reported Change From Baseline Scale | 1=Mild Improvement | 1 Participants |
| Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion | Subject Reported Change From Baseline Scale | 2=Moderate Improvement | 2 Participants |