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.
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.
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
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
1. Subjects or parents of subjects who are unable to understand the protocol or to give
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
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.