Status:
COMPLETED
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Lead Sponsor:
Derm Research, PLLC
Conditions:
Acne Vulgaris
Post Inflammatory Hyperpigmentation
Eligibility:
All Genders
12+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03402893
Start Date
July 28 2017
End Date
February 28 2018
Last Update
April 2 2019
Active Locations (1)
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1
DermResearch, PLLC
Louisville, Kentucky, United States, 40217