The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Global Assessment Scale for Severity of Facial Acne |
0; 0; 11; 9; 0; 0 | — |
| PRIMARY Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation |
0; 2; 17; 1; 0; 0 | — |
| SECONDARY Percent Change in Inflammatory Lesions |
-35; -55; -76 | — |
| SECONDARY Percent Change in Non-inflammatory Lesion Count |
-21; -41; -62 | — |
| SECONDARY Percent Change in Total Lesion Count |
-29; -51; -71 | — |
| SECONDARY Post-Inflammatory Hyperpigmentation (PIH) Distribution |
0; 2; 3; 6; 4; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT03402893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.