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

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Salicylates; Salicylic Acid

Criteria

Inclusion Criteria:

• diagnosis of rosacea, with both papular/pustular lesions and facial erythema

Exclusion Criteria:

• patients with active skin infection involving the face

• patients with severe nodular or phymatous rosacea with ocular involvement

• patients with other dermatoses that may interfere with the evaluation of rosacea

• patients who are pregnant or breastfeeding

• use of isotretinoin within the last year

• history of hypersensitivity to chemical peeling

• patients who easily scar or have dyspigmentation tendencies

• patients who continue to experience excessive sun exposure

• patients planning to change or initiate other treatments for their rosacea during the study period