The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color

Inclusion Criteria:

i. Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing
potential must have a negative urine pregnancy test result at Baseline and practice a
reliable method of contraception throughout the study;

A female is considered of childbearing potential unless she is:

- postmenopausal for at least 12 months prior to study drug administration

- without a uterus and/or both ovaries; or

- has been surgically sterile for at least 6 months prior to study drug administration

Reliable methods of contraception are:

- intrauterine device in use ≥ 90 days prior to study drug administration;

- barrier methods plus spermicide in use at least 14 days prior to study drug
administration; or

- vasectomized partner

[Exception: Female subjects of childbearing potential who are not sexually active will not
be required to practice a reliable method of contraception. These subjects may be enrolled
at the Investigator's discretion if they are counseled to remain sexually inactive during
the study and understand the possible risks in getting pregnant during the study.]

ii. Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V & VI Supplement
VI) characterized by the following:

- IGA Score for acne vulgaris 3

- IGA Score for PIH 3

iii. Able to understand and comply with the requirements of the study and sign Informed
Consent /HIPAA Authorization forms

Exclusion Criteria:

i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who
are of childbearing potential and not practicing a reliable method of birth control

ii. Allergy/sensitivity to any component of the test treatment

iii. IGA score for acne of 2 (mild) or 4 (severe)

iv. IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)

v. Subjects who have not complied with the proper wash-out periods for prohibited
medications (Supplement I).

vi. Medical condition that, in the opinion of the Investigator, contraindicates the
subject's participation in the clinical study

vii. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne
vulgaris

viii. Evidence of recent alcohol or drug abuse

ix. History of poor cooperation, non-compliance with medical treatment, or unreliability

x. Exposure to an investigational study drug within 30 days of the Baseline Visit