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

NCT04889703 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-03-01

No results posted yet for this study

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

Conditions

  • Rosacea

Interventions

DRUG

15% Trichloroacetic acid peel

Trichloroacetic acid peel (15%) will be applied topically to the face for 2 treatments at 4 week intervals.

DRUG

30% Salicylic acid peel

Salicylic acid peel (30%) will be applied topically to the face for 2 treatments at 4 week intervals.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-12-31
Completion
2024-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889703 on ClinicalTrials.gov