drugset / Trial / NCT05608499

Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

NCT05608499

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Acne keloidalis nuchae (AKN) is one of the chronic forms of scarring folliculitis, affecting predominantly the occipital scalp, seen mostly in men of African descent. Duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the FDA with dermatologic indication. Researchers are proposing the off-labeled use of Duobrii for the management of early-mild AKN. The research team hypothesizes that subjects will experience significant clinical improvement in lesion counts. Patients will be followed with visits scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. During these in-clinic visits, there will be surveys regarding the severity of AKN symptoms, photographs, and clinical assessments.

Timeline

Start
2022-10-26
Primary completion
2024-04-15
Completion
2024-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Tazarotene Small molecule Topical
Background halobetasol propionate Small molecule Topical
Background halobetasol propionate Small molecule Topical

Indications