A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions

Inclusion Criteria:

1. Capable of understanding and willing to provide signed and dated written voluntary
informed consent (and any local or national authorization requirements) before any
protocol specific procedures are performed.

2. Fitzpatrick Skin Type I - V.

3. Male or female aged from 12 to 45 years, inclusive, at time of consent.

4. Mild to moderate facial acne vulgaris as determined by the Investigator, with a
minimum of 10 inflammatory lesions (papules plus pustules, including nasal lesions)
and a minimum of 10 non-inflammatory lesions (open and closed comedones, including
nasal lesions).

5. Three appropriate and evaluable target lesions, as judged by the Investigator.

6. Able to complete the study and to comply with study instructions.

7. Sexually active females of childbearing potential participating in the study must
agree to use a medically acceptable method of contraception while receiving
protocol-assigned product. A woman of childbearing potential is defined as one who
is biologically capable of becoming pregnant; including perimenopausal women who are
less than 2 years from their last menses. Acceptable contraceptive methods include
the following:

- Hormonal contraception, including oral, injectable, or implantable methods
started at least 2 months prior to screening. If hormonal contraception was
started less than 2 months prior to screening, then a form of nonhormonal
contraception should be added until the third continuous month of hormonal
contraception has been completed.

"• Two forms of reliable nonhormonal contraception, to include the use of either an
intrauterine device plus a reliable barrier method or 2 reliable barrier methods.
Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable
barrier method, provided that the female subject has never given birth naturally. The
combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal
contraception, provided that they are both used properly. The use of spermicide alone and
the improper use of condoms are inferior methods of contraception. Subjects with surgical
sterilization, including tubal sterilization or partner's vasectomy, must use a form of
nonhormonal contraception. A barrier method or sterilization plus spermicide is
acceptable.

• Women who are not currently sexually active must agree to use a medically accepted
method of contraception should they become sexually active while participating in the
study.

Exclusion Criteria:

1. Has any nodulocystic lesions at the baseline evaluation.

2. Female who is pregnant, trying to become pregnant, or breastfeeding.

3. Has active or chronic skin allergies.

4. Has a history of acute or chronic disease that might interfere with or increase the
risk of study participation.

5. Had skin cancer treatment in preceding 12 months.

6. Has damaged skin on facial areas (e.g., sunburn, tattoo, or scar).

7. Had any medical procedure (e.g., laser resurfacing, chemical peel, or plastic
surgery) on facial areas in preceding 12 months.

8. Had any cosmetic procedure (e.g., microdermabrasion) on facial areas within 8 weeks
of the baseline visit.

9. Has any dermatological disorder that in the opinion of the Investigator may interfere
with the accurate evaluation of the subject's facial appearance.

10. Received any investigational drug or procedure within 28 days of study day 1 or is
scheduled to receive an investigational drug (other than the study products) or
procedure during the study.

11. Currently using any medication that in the opinion of the Investigator may affect the
evaluation of the study products or place the subject at undue risk.

12. Has a history of known or suspected intolerance to any of the ingredients of the
study products (i.e., benzoyl peroxide).

13. Considered unable or unlikely to attend the necessary visits.

14. Has used non-steroidal anti-inflammatory drugs for the treatment of acne or for
treatment durations longer than 7 days for any condition.

15. Uses oil-based sunscreens or sunscreens containing active ingredients that may have
an effect on acne.

16. Has received treatment with estrogens (including oral, implanted, and topical
contraceptives), androgens, or anti-androgenic agents for 12 weeks or less
immediately prior to starting application of the study product. Subjects who have
been treated with estrogens, as described above, androgens, or anti-androgenic agents
for more than 12 consecutive weeks prior to starting application of the study product
are allowed to enroll as long as they do not expect to change dose, drug, or
discontinue use during the study.

17. Has used topical antibiotics on the face or use of systemic antibiotics within the
previous 2 weeks.

18. Has used topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol,
salicylates) within the previous 2 weeks.

19. Has used topical corticosteroids on the face or systemic cortico- steroids within the
previous 4 weeks. Use of inhaled, intra-articular or intra-lesional steroids other
than for facial acne is acceptable.

20. Has used systemic retinoids within the previous 6 months or topical retinoids within
the previous 6 weeks.

21. Uses abradants, facials, peels containing glycolic or other acids; masks, washes or
soaps containing BPO, salicylic acid, or sulfacetamide sodium; non-mild facial
cleansers, or moisturizers that contain retinol, salicylic acid or α- or β-hydroxy
acids.

22. Uses medications known to exacerbate acne (e.g., mega-doses of vitamin D [>2000
IU/day] and vitamin B12 [>1 mg/day]; systemic steroids; androgens; haloperidol;
halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital).

23. Has had any facial procedure (e.g., blue light, chemical or laser peel,
microdermabrasion) performed by any practitioner within 4 weeks before the study
started or during the course of the study.

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