SADBE for Alopecia Areata

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called squaric acid dibutyl ester (SADBE) for children and teens with alopecia areata (AA), a condition that causes hair loss. Researchers aim to assess SADBE's effectiveness and patient tolerance. The trial includes two groups: one will receive SADBE for 12 months, while the other will start with a placebo for 4 months before switching to SADBE for 8 months. Participants should have experienced more than 10% hair loss on their scalp, with no hair regrowth in the past six months, and have been dealing with this current episode of hair loss for less than five years. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that squaric acid dibutylester (SADBE) is often used to treat alopecia areata, a condition that causes hair loss. Many reports support its effectiveness. Some studies have examined its safety when applied to the skin. In one study with 70 patients, many experienced hair regrowth, but some had moderate skin irritation. This indicates that the treatment can have side effects, though they are usually mild.

Another study found that SADBE is one of the most effective treatments for alopecia areata and is recommended by experts. This suggests that while side effects may occur, the benefits might outweigh the risks for many people. It is important to note that this treatment is still being tested in early trials for safety and effectiveness, especially in children and teens. So far, evidence suggests SADBE is generally well-tolerated, but more research is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alopecia areata?

Researchers are excited about Squaric Acid Dibutyl Ester (SADBE) for treating alopecia areata because it offers a new approach compared to existing treatments like corticosteroids and immunotherapy. Unlike these options, which often suppress the immune system broadly, SADBE works by creating a localized allergic reaction that can redirect the immune response, helping hair regrow. This method may reduce the systemic side effects associated with other treatments, making it a potentially safer and more targeted option for patients. Additionally, SADBE's unique mechanism of action provides hope for those who haven't responded well to conventional therapies.

What evidence suggests that squaric acid dibutyl ester might be an effective treatment for alopecia areata?

Research has shown that squaric acid dibutyl ester (SADBE) effectively treats alopecia areata, a condition causing hair loss. In studies, 57.8% of patients using SADBE improved. Specifically, 11.1% experienced complete hair regrowth, while 46.7% saw partial regrowth. Patients with the condition for 1 to 5 years responded better to the treatment. This trial will evaluate two approaches: one group will receive 12 months of SADBE 5%, while another group will start with 4 months of placebo followed by 8 months of SADBE 5%. SADBE appears promising for those with alopecia areata, especially if they have had it for a few years. ^{1 2 3 6 7}

Who Is on the Research Team?

Adelaide Hebert, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. naaf.org naaf.org/studies/study-evaluating-efficacy-of-topical-squaric-acid-dibutyl-ester-in-children-and-adolescents-with-alopecia-areata-sadbe-hd/

Study Evaluating Efficacy of Topical Squaric Acid Dibutyl ... A clinical research study is currently looking for children ages 12-17 with a diagnosis of alopecia areata who have lost 10% or more of the hair on their head ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4960932/

Comparative Study of Efficacy and Safety of Topical ... Topical squaric acid dibutylester and diphenylcyclopropenone are still the most effective therapy for alopecia areata among widely available treatment options.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33377267/

Squaric acid dibutyl ester for the treatment of alopecia areata Patients with a disease duration between 1 and 5 years responded better to the SADBE treatment compared to those with a disease shorter than 1 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05414266

Study Evaluating Efficacy of Topical Squaric Acid Dibutyl ... The purpose of this study is to evaluate the efficacy and tolerability of squaric acid dibutylester (SADBE) in children and adolescents with alopecia areata ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1323893019301728

Effect of topical immunotherapy with squaric acid ... The improvement rate in all alopecia patients treated with SADBE topical immunotherapy was 57.8% (complete response; 11.1% and partial response; 46.7%).

6. jddonline.com jddonline.com/articles/efficacy-and-safety-of-the-topical-sensitizer-squaric-acid-dibutyl-ester-in-alopecia-areata-and-fact-S1545961606P0262X/

Efficacy and Safety of the Topical Sensitizer Squaric Acid ... Objective: To study efficacy, safety, and factors influencing the outcome in the treatment of alopecia areata. Method: During a 4-year period, 70 patients of ...

7. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/548501

Treatment of Alopecia Areata With Squaric Acid Dibutylester Ten patients (71.4%) were treatment failures. Of these ten failures, seven developed a moderate dermatitis and hair regrowth but experienced recurrent alopecia ...