SADBE for Alopecia Areata

Recruiting in Houston (>99 mi)

Overseen By Adelaide Hebert

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Steroids, JAK inhibitors, others

Disqualifiers: Scalp disease, Systemic diseases, Psychiatric condition, Malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants be on a stable regimen of allowed medications, but some medications must be stopped before joining. For example, topical steroids must be stopped 2 weeks before, and certain immune suppressants and other treatments must be stopped 8 weeks before the study starts.

What data supports the effectiveness of the treatment Squaric Acid Dibutyl Ester (SADBE) for alopecia areata?

Research shows that SADBE can be effective for some people with alopecia areata, with studies reporting response rates ranging from about 32% to 69%. It has been particularly useful for patients who have not responded to other treatments, although some people may experience side effects. ^{1 2 3 4 5}

Is squaric acid dibutyl ester (SADBE) safe for treating alopecia areata?

SADBE is generally considered to have mild side effects and good tolerability, but some patients may experience adverse effects like severe contact dermatitis (skin irritation). ^{1 2 3 4 6}

How is the drug SADBE different from other treatments for alopecia areata?

SADBE is unique because it is a topical immunotherapy that works by causing a mild allergic reaction on the skin to stimulate hair regrowth, which is different from other treatments that might use steroids or other systemic medications. It is particularly used for patients who have not responded to conventional therapies, and its effectiveness can vary based on factors like the duration and severity of the disease. ^{1 2 3 4 7}

What is the purpose of this trial?

This trial is testing a chemical called SADBE to help children and teens with hair loss grow their hair back. The treatment works by causing a small skin reaction that can wake up hair follicles. SADBE is known for its low side-effect profile and hair regrowth potential.

Research Team

Adelaide Hebert, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for children and adolescents with alopecia areata who have experienced hair loss for less than 5 years and have more than 10% scalp hair loss without regrowth in the past 6 months. Participants must avoid UV light exposure, not be pregnant or breastfeeding, use contraception if applicable, and cannot have certain skin diseases, active infections, a history of significant psychiatric conditions or substance abuse.

Inclusion Criteria

I have lost more than 10% of my scalp hair without regrowth in the last 6 months.

Evidence of a personally signed and dated informed consent document

Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

I haven't used treatments that could affect my condition, like steroids or minoxidil, in the last 8 weeks.

I am able to communicate and cooperate with my doctor.

Participants with shaved heads must not enter the study until hair has grown back to a reasonable level and is considered stable, in the opinion of the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or 5% SADBE for 12 months to evaluate efficacy and tolerability in treating alopecia areata

12 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

1 visit (in-person)

Treatment Details

Interventions

• Squaric Acid Dibutyl Ester

Trial Overview The study tests the effectiveness of a topical treatment called squaric acid dibutyl ester (SADBE) at a concentration of 5%, compared to a placebo. It aims to assess how well SADBE works from both patient-centered outcomes and economic perspectives.

Participant Groups

Group I: 4 months Placebo, then 8 months SADBE 5% Experimental Treatment 2 Interventions

Group II: 12 months SADBE 5% Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Modified immunotherapy for alopecia areata. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Squaric acid dibutyl ester in the treatment of alopecia areata. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Squaric acid dibutyl ester for the treatment of alopecia areata: A retrospective evaluation. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of severe alopecia areata with squaric acid dibutylester in pediatric patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Topical therapy of alopecia areata with squaric acid dibutylester. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Treatment of alopecia areata with squaric acid dibutylester. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical experience on the treatment of alopecia areata with squaric acid dibutyl ester. [2022]