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Study Evaluating Efficacy of Topical Squaric Acid Dibutyl Ester in Children and Adolescents With Alopecia Areata

NCT05414266 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-10-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and tolerability of squaric acid dibutylester (SADBE) in children and adolescents with alopecia areata (AA) and to evaluate effect of squaric acid dibutyl ester on patient-centered outcomes and payer relevant measures to assess treatment benefit from the patient perspective and to demonstrate value

Conditions

Interventions

DRUG

Placebo

Placebo is acetone. At baseline, the investigator will record the area that will be treated in mm2 . Use of a 1 mm x 1 mm gridded transparency will be used to record the treatment area at baseline. At subsequent visits, the study intervention will be applied to the entire treatment area defined at baseline, regardless of any new hair growth. The assigned study intervention is applied monthly by the PI (or designee) to the treatment areas affected by AA on the scalp and/or eyebrows identified at Baseline. The topical solution is applied with a cotton tip applicator by the PI or their qualified designee. Solution is applied by gently pressing a cotton tip applicator that has been soaked in the study solution against the skin. Treatment is repeated monthly.

DRUG

SADBE 5%

SADBE 5% is a solution of 5% Squaric Acid Dibutyl Ester (SADBE) in acetone. At baseline, the investigator will record the area that will be treated in mm2 . Use of a 1 mm x 1 mm gridded transparency will be used to record the treatment area at baseline. At subsequent visits, the study intervention will be applied to the entire treatment area defined at baseline, regardless of any new hair growth. The assigned study intervention is applied monthly by the PI (or designee) to the treatment areas affected by AA on the scalp and/or eyebrows identified at Baseline. The topical solution is applied with a cotton tip applicator by the PI or their qualified designee. Solution is applied by gently pressing a cotton tip applicator that has been soaked in the study solution against the skin. Treatment is repeated monthly.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Adelaide Hebert, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2023-06-01
Completion
2024-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT05414266 on ClinicalTrials.gov