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

• ONEXTON Topical Gel (Drug): Onexton gel applied once daily to face

Primary outcomes

• Investigator Global Assessment Scale for Severity of Facial Acne [Week 4, Week 8, Week 16]: Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.
• Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation [Week 4, Week 8, Week 16]: Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression

Secondary outcomes

• Percent Change in Inflammatory Lesions [Week 4, Week 8, Week 16]: The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules.
• Percent Change in Non-inflammatory Lesion Count [Week 4, Week 8, Week 16]: The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.
• Percent Change in Total Lesion Count [week 4, Week 8, Week 16]: The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones.
• Post-Inflammatory Hyperpigmentation (PIH) Distribution [baseline, Week 4, week 8, week 16]: This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease.

Sex: All, ages: 12 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• Investigator Global Assessment Scale for Severity of Facial Acne (Primary), Count of participants, Participants: Onexton Gel Application 0
• Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation (Primary), Count of participants, Participants: Onexton Gel Application 0
• Percent Change in Inflammatory Lesions (Secondary), Mean, percent change: Onexton Gel Application -35 +/- 17
• Percent Change in Non-inflammatory Lesion Count (Secondary), Mean, percent change: Onexton Gel Application -21 +/- 22
• Percent Change in Total Lesion Count (Secondary), Mean, percent change: Onexton Gel Application -29 +/- 17
• Post-Inflammatory Hyperpigmentation (PIH) Distribution (Secondary), Count of participants, Participants: Single Arm Onexton Gel Application 0

Adverse events

Time frame: screening to week 16

Other adverse events by term

• Informed Consent Form (PDF, 2017-06-12)
• Study Protocol and Statistical Analysis Plan (PDF, 2017-01-31)