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

NCT03402893 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ONX-1701
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Investigator Global Assessment Scale for Severity of Facial Acne

  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.

  Week 4, Week 8, Week 16

• Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation

  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

  Week 4, Week 8, Week 16

Secondary Outcomes (4)

• Percent Change in Inflammatory Lesions

  Week 4, Week 8, Week 16

• Percent Change in Non-inflammatory Lesion Count

  Week 4, Week 8, Week 16

• Percent Change in Total Lesion Count

  week 4, Week 8, Week 16

• Post-Inflammatory Hyperpigmentation (PIH) Distribution

  baseline, Week 4, week 8, week 16

Study Arms (1)

single arm Onexton gel application

EXPERIMENTAL

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

Drug: ONEXTON Topical Gel

Interventions

ONEXTON Topical Gel DRUG

Onexton gel applied once daily to face

single arm Onexton gel application

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Derm Research, PLLC: lead

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Hyperpigmentation

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pigmentation Disorders

Results Point of Contact

• Title: M. McAllister
• Organization: Skin Sciences, PLLC

mmdermresearch@yahoo.com

5024519000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: July 28, 2017
• Primary Completion: November 15, 2017
• Study Completion: February 28, 2018
• Last Updated: April 2, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-03

Locations

US (1)