drugset / Trial / NCT04889703

A Pilot Study Testing the Effects of Chemical Peels in Patients With Rosacea

NCT04889703

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is a prospective, randomized, one-site therapeutic trial of 15% trichloroacetic acid (TCA) and 30% salicylic acid peels for rosacea. Two peels will be applied topically 4 weeks apart, and the study will end in 12 weeks. Endpoints include adverse affects within the first 8 weeks and responses, which will be measured by Investigator Global Assessment (IGA), a Rosacea Clinical Scorecard, and number of papular plus pustular lesions assessed every 4 weeks up to 12 weeks with high resolution photographs. Treatment Dosage and administration Study Drugs: 1. Trichloroacetic acid peel (15%) will be applied topically to the face for 2 treatments at 4 week intervals. 2. Salicylic acid peel (30%) will be applied topically to the face for 2 treatments at 4 week intervals. Duration of treatment: two single applications 4 weeks apart. Endpoint: 12 weeks after first chemical peel treatment Outcome measures: * independent objective reviewer scoring of matched photographs before and after treatment * number of papular and pustular lesions before and after treatment * rosacea-specific patient quality of life survey responses before and after treatment * Adverse effects such as peeling, redness, scaling, crusting, blister formation, and hyperpigmentation will be assessed clinical

Timeline

Start
2022-12
Primary completion
2023-12
Completion
2024-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Trichloroacetic acid Small molecule 15 % Topical
Subject salicylic acid Small molecule 30 % Topical

Indications