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

Completed · Phase 4

Conditions studied: Acne Vulgaris, Post Inflammatory Hyperpigmentation

In brief

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.

Key facts

Study ID

NCT03402893

Run by

Derm Research, PLLC

People needed

21

Starts

2017-07-28

Expected to finish

2018-02-28

Last updated by the study team

2019-04-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• DermResearch, PLLC — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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