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

NCT04889703 | Withdrawn

• 1 other identifier: STU-2020-0804
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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:

• 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

Outcome Measures

Primary Outcomes (4)

• Independent objective reviewer scoring of matched photographs

  Two independent investigators will score matched photographs of the baseline rosacea at time point 0 weeks using a scale from 0 to 6. 0 indicates no papules, pustules, residual erythema, or telangiectasia; 1 indicates rare papules and/or pustules, residual to mild erythema, and mild to moderate telangiectasia; 2 indicates few papules and/or pustules, mild erythema, and mild to moderate telangiectasia; 3 indicates a distinct number of papules and/or pustules, mild to moderate erythema, and mild to moderate telangiectasia; 4 indicates a pronounced number of papules and/or pustules, moderate erythema, and mild to moderate telangiectasia; 5 indicates many papules and/or pustules occasionally with large inflamed lesions, moderate erythema, and moderate telangiectasia; and 6 indicates numerous papules and/or pustules occasionally with confluent areas of inflamed lesions, moderate or severe erythema, and moderate or severe telangiectasia.

  Done at 0 weeks of study

• Independent objective reviewer scoring of matched photographs

  Two independent investigators will score matched photographs of the baseline rosacea at time point 4 weeks using a scale from 0 to 6. 0 indicates no papules, pustules, residual erythema, or telangiectasia; 1 indicates rare papules and/or pustules, residual to mild erythema, and mild to moderate telangiectasia; 2 indicates few papules and/or pustules, mild erythema, and mild to moderate telangiectasia; 3 indicates a distinct number of papules and/or pustules, mild to moderate erythema, and mild to moderate telangiectasia; 4 indicates a pronounced number of papules and/or pustules, moderate erythema, and mild to moderate telangiectasia; 5 indicates many papules and/or pustules occasionally with large inflamed lesions, moderate erythema, and moderate telangiectasia; and 6 indicates numerous papules and/or pustules occasionally with confluent areas of inflamed lesions, moderate or severe erythema, and moderate or severe telangiectasia.

  Done at 4 weeks of study

• Independent objective reviewer scoring of matched photographs

  Two independent investigators will score matched photographs of the baseline rosacea at time point 8 weeks using a scale from 0 to 6. 0 indicates no papules, pustules, residual erythema, or telangiectasia; 1 indicates rare papules and/or pustules, residual to mild erythema, and mild to moderate telangiectasia; 2 indicates few papules and/or pustules, mild erythema, and mild to moderate telangiectasia; 3 indicates a distinct number of papules and/or pustules, mild to moderate erythema, and mild to moderate telangiectasia; 4 indicates a pronounced number of papules and/or pustules, moderate erythema, and mild to moderate telangiectasia; 5 indicates many papules and/or pustules occasionally with large inflamed lesions, moderate erythema, and moderate telangiectasia; and 6 indicates numerous papules and/or pustules occasionally with confluent areas of inflamed lesions, moderate or severe erythema, and moderate or severe telangiectasia.

  Done at 8 weeks of study

• Independent objective reviewer scoring of matched photographs

  Two independent investigators will score matched photographs of the baseline rosacea at time point 12 weeks using a scale from 0 to 6. 0 indicates no papules, pustules, residual erythema, or telangiectasia; 1 indicates rare papules and/or pustules, residual to mild erythema, and mild to moderate telangiectasia; 2 indicates few papules and/or pustules, mild erythema, and mild to moderate telangiectasia; 3 indicates a distinct number of papules and/or pustules, mild to moderate erythema, and mild to moderate telangiectasia; 4 indicates a pronounced number of papules and/or pustules, moderate erythema, and mild to moderate telangiectasia; 5 indicates many papules and/or pustules occasionally with large inflamed lesions, moderate erythema, and moderate telangiectasia; and 6 indicates numerous papules and/or pustules occasionally with confluent areas of inflamed lesions, moderate or severe erythema, and moderate or severe telangiectasia.

  Done at 12 weeks of study

Secondary Outcomes (6)

• Total number of papular and pustular lesions

  Done at 0 weeks of study

• Total number of papular and pustular lesions

  Done at 4 weeks of study

• Total number of papular and pustular lesions

  Done at 8 weeks of study

• Total number of papular and pustular lesions

  Done at 12 weeks of study

• Rosacea Quality of Life (QOL) Survey Response

  Completed by patient at 0 weeks of study

Study Arms (2)

15% Trichloroacetic acid (TCA) chemical peel

EXPERIMENTAL

15% trichloroacetic acid will be applied topically on the skin of the entire face in two separate clinic visits that are 4 weeks apart

Drug: 15% Trichloroacetic acid peel

30% Salicylic acid chemical peel

EXPERIMENTAL

30% salicylic acid will be applied topically on the skin of the entire face in two separate clinic visits that are 4 weeks apart

Drug: 30% Salicylic acid peel

Interventions

15% Trichloroacetic acid peel DRUG

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

15% Trichloroacetic acid (TCA) chemical peel

30% Salicylic acid peel DRUG

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

30% Salicylic acid chemical peel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 17, 2021
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share