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

NCT ID: NCT03402893

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-28
• Study Completion Date: 2018-02-28

Brief 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.

Conditions

Acne Vulgaris; Post Inflammatory Hyperpigmentation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm Onexton gel application

Onexton gel will be supplied to all subjects and applied once daily to the face

Group Type: EXPERIMENTAL

ONEXTON Topical Gel

Intervention Type: DRUG

Onexton gel applied once daily to face

Interventions

ONEXTON Topical Gel

Onexton gel applied once daily to face

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Derm Research, PLLC

OTHER

Sponsor Role: lead

Responsible Party

L.H. Kircik, M.D.

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DermResearch, PLLC

Louisville, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ONX-1701

Identifier Type: -

Identifier Source: org_study_id