Comparison of Two Salicylic Acid Formulations

Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the
face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent
multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels
through the follicular canal to the skin surface, carrying along with it desquamated cells
from follicular epithelium. Acne develops when these specialized follicles undergo pathologic
alterations that result in the formation of non-inflammatory lesions (comedones) and
inflammatory lesions (papules, pustules, and nodules)1.

The basic cause of acne remains unknown, but its manifestations are thought to be the product
of four pathogenic events: 1) increased sebum production fueled by androgenic stimulation in
the pubertal period; 2) obstruction of the pilosebaceous unit due to an abnormal
keratinization process; 3) proliferation of Propionibacterium acnes, an anaerobic diphtheroid
normally residing in pilosebaceous follicles; and 4) inflammation that is mediated both by
the action of chemotactic factors and various enzymes, and initiated in part by the
interaction of P. acnes with toll-like receptors. Impaction of the pilosebaceous follicle
gives rise to the microcomedo that is thought to be the precursor lesion of acne1.

Topical salicylic acid is a common and well-established agent with known keratolytic
properties used in the treatment of acne vulgaris. The safety profile for topical salicylic
acid has been well delineated. The most common side effects attributed to salicylic acid
products include irritation, dryness, scaling, burning and stinging.

Salicylic acid 1.0% creams (Formulation A and Formulation B) will be evaluated to detect any
differences in their response for safety and efficacy.

Inclusion Criteria:

1. Healthy male or female subjects who are 13 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 5 inflammatory lesions (papules and pustules) on each side of the face,
and a minimum of 5 non-inflammatory lesions (open comedones and closed comedones on
each side of the face. Lesions should be relatively symmetrical in appearance on both
sides of the face. At least one inflammatory lesion should be measured no smaller than
2 mm in diameter and should be visible on each side of the face in images taken with
digital imaging station.

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 allergy or sensitivity to salicylic acid,
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.