The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Condition: Acne Vulgaris; Post Inflammatory Hyperpigmentation
MeSH terms: Acne Vulgaris; Hyperpigmentation
Intervention: ONEXTON Topical Gel
Intervention description: Onexton gel applied once daily to face
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single-center, open label pilot study. The study is comprised of 5 study visits;
      Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline
      and be instructed to apply the gel once daily to the face. The investigators will evaluate
      Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count,
      non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory
      Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and
      concomitant medications.
    

Eligibility criteria:

        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