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RosaceaNCT04889703

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

A study testing 15% Trichloroacetic acid peel and 30% Salicylic acid peel in people with Rosacea, run by University of Texas Southwestern Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rosacea
What is being tested?
15% Trichloroacetic acid peel and 30% Salicylic acid peel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2022to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

About this study

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

Read more

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
Read the detailed description

Patients with a diagnosis of rosacea will be included. Peels will be performed at no cost to participants; funding will be supplied by the UT Southwestern Dermatology department. A total of 20 patients will be consented. At the initial visit, patients will fill out a form with demographic information as well as a RosaQOL survey about how their rosacea has affected their quality of life. High-quality photographs of each patient's baseline rosacea will be taken. The treatment arms of 15% TCA peel and 30% salicylic acid peel will be randomly assigned to patients, and the topical treatment will be applied to the entire face. The duration of involvement of each subject from the time of initial consent to final clinical evaluation will be 12 weeks. There will be a total of 4 clinical visits lasting approximately 30 minutes per visit. Each patient will undergo two chemical peel treatments, with a 4-week interval between treatments. The first treatment will occur at 0 weeks (first visit). Each patient will follow up at 4 weeks (second visit) for his or her second chemical peel treatment. After two treatments, the patient will then follow up at 8 weeks (third visit) and 12 weeks (fourth visit) for evaluation of response to treatment.

For the chemical peel treatment, each patient's face will be prepared by cleansing with a deep cleanser, followed by removal of sebum utilizing either alcohol or acetone as a degreasing agent, and allowing the skin to dry. These steps help optimize penetration of the peeling agent. The peeling agent will then be applied uniformly to the face with a 2X2 gauze pad with the patient in supine position until adequate erythematous response is observed. If needed, the acidic peeling agent may be neutralized with water. Patients will be instructed to apply Vaseline and sunscreen to the face daily post-treatment to keep the skin moisturized and protected from UV radiation until exfoliation is complete, typically within 7-10 days post-peel.

The outcome measures will include patient quality of life survey responses, independent objective reviewer scoring of matched photographs, and comparisons of the number of papular and pustular lesions before and after treatment. At each visit, the total number of papular and pustular lesions will be recorded. High resolution photographs of both the left and right sides of the face will be taken at the first visit to serve as each patient's baseline rosacea. Patients will also be asked to complete the RosaQOL survey at the first clinical visit. Additional photographs will be taken at all four visits using identical lighting, positioning, and settings for all patients. Two independent investigators will score matched photographs of the baseline and treated rosacea at time points 0 weeks, 8 weeks, and 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 telangiectasia16. Independent observer scores will be graded using the same method and same scale for all patients.

At the 12-week follow up visit, patients will be asked to repeat the RosaQOL survey. Photographs will be taken, and a final documentation of gross number of papular and pustular lesions will be recorded.

Conditions
Rosacea
Being tested
15% Trichloroacetic acid peel, 30% Salicylic acid peel
Medical subject headings
Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 15% Trichloroacetic acid peelDrug

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

  • 30% Salicylic acid peelDrug

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

Study groups in NCT04889703
Study groupRoleWhat they receive
15% Trichloroacetic acid (TCA) chemical peelExperimental15% trichloroacetic acid will be applied topically on the skin of the entire face in two separate clinic visits that are 4 weeks apart
Receives: Drug: 15% Trichloroacetic acid peel
30% Salicylic acid chemical peelExperimental30% salicylic acid will be applied topically on the skin of the entire face in two separate clinic visits that are 4 weeks apart
Receives: Drug: 30% Salicylic acid peel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Done at 0 weeks of study

  2. 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.

    Measured: Done at 4 weeks of study

  3. 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.

    Measured: Done at 8 weeks of study

  4. 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.

    Measured: Done at 12 weeks of study

Secondary outcomes (6)
  1. Total number of papular and pustular lesions

    The total number of papular and pustular lesions will be recorded by the researcher.

    Measured: Done at 0 weeks of study

  2. Total number of papular and pustular lesions

    The total number of papular and pustular lesions will be recorded by the researcher.

    Measured: Done at 4 weeks of study

  3. Total number of papular and pustular lesions

    The total number of papular and pustular lesions will be recorded by the researcher.

    Measured: Done at 8 weeks of study

  4. Total number of papular and pustular lesions

    The total number of papular and pustular lesions will be recorded by the researcher.

    Measured: Done at 12 weeks of study

  5. Rosacea Quality of Life (QOL) Survey Response

    Patients will be asked to complete a rosacea-specific quality of life survey before the initiation of treatment to measure thoughts about their baseline rosacea. Answers are based on a scale from 1-5 and are quantifiable.

    Measured: Completed by patient at 0 weeks of study

  6. Rosacea Quality of Life (QOL) Survey Response

    Patients will be asked to complete a rosacea-specific quality of life survey after completion of treatment to measure thoughts about their rosacea. Answers are based on a scale from 1-5 and are quantifiable.

    Measured: Completed by patient at 12 weeks of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2021
  2. Study startDec 2022 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionMay 2024 (estimated)

Why it stopped: Plan to move forward with this study has been dropped

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04889703
Sponsor's protocol ID
STU-2020-0804
Status last verified
Feb 2023
First submitted
27 Apr 2021
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 15% Trichloroacetic acid peel and 30% Salicylic acid peel in people with Rosacea, run by University of Texas Southwestern Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Independent objective reviewer scoring of matched photographs (time frame: Done at 0 weeks of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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