What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata, such as Squaric Acid Dibutylester (SADBE) and Diphenylcyclopropenone (DPCP), can cause side effects including local skin reactions like redness, itching, and mild dermatitis. Severe eczematous reactions may occur, necessitating adjustments in treatment concentration. Cyclosporine, another treatment option, can lead to serious adverse effects like liver enzyme elevation, pancreatitis, and bone marrow suppression, making it unsuitable for long-term use. Sulfasalazine may cause gastrointestinal distress, headache, fever, rash, and, less frequently, hematologic disorders and hepatotoxicity.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Alopecia Areata that work by inducing a mild allergic reaction to stimulate hair regrowth, such as Squaric Acid Dibutylester (SADBE). However, topical immunotherapy with agents like SADBE and Diphenylcyclopropenone (DPCP) is commonly used off-label. These treatments aim to modulate the immune response to promote hair regrowth. Other treatments for Alopecia Areata include corticosteroids, minoxidil, and various immunosuppressive agents, but these do not work through the same mechanism as SADBE.

What other types of research exist?

Promising alternatives to Squaric Acid Dibutylester for Alopecia Areata include: <ol> <li>Topical Bimatoprost: A prostaglandin analog that has shown efficacy in enhancing eyelash growth and may be beneficial for scalp hair regrowth.</li> <li></li> </ol> Topical and Oral Minoxidil: Known for its effectiveness in hair regrowth, with oral minoxidil showing significant improvement in hair density. 3. Spironolactone: An androgen receptor antagonist that has shown limited but clear efficacy in some patients with alopecia. 4. Topical Calcitriol: Although data are limited, it has shown potential in protecting against chemotherapy-induced alopecia in animal studies.

← Back to Search

Contact Sensitizing Agent

SADBE for Alopecia Areata

Phase < 1

Waitlist Available

Led By Adelaide Hebert, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who are women of childbearing potential (WOCBP) must agree to use one highly effective method of contraception

Have a clinical diagnosis of AA with no other etiology of hair loss

Must not have

Participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function

Known primary or secondary immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 1,month2,month 3, month 4, month 5, month 6, month 7, month 8,month 9, month 10, month 11, month 12,month 14,early termination visit (occurs only if subject discontinues form study)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical reactions to topical treatments like SADBE may include skin irritation, redness, itching or burning sensation at the application site. Systemic side effects are unlikely but could occur depending on individual sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I agree to use a highly effective birth control method.

Select...

I have been diagnosed with alopecia areata and no other cause for my hair loss.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am able to communicate and cooperate with my doctor.

Select...

I or a close family member have an immune system disorder.

Select...

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

Select...

I haven't taken antibiotics or antivirals for infections in the last 4 weeks.

Select...

I haven't taken JAK inhibitors or similar drugs recently.

Select...

I need surgery urgently.

Select...

I have not taken herbal medications that could affect the study drug within the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 1,month2,month 3, month 4, month 5, month 6, month 7, month 8,month 9, month 10, month 11, month 12,month 14,early termination visit (occurs only if subject discontinues form study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 1,month2,month 3, month 4, month 5, month 6, month 7, month 8,month 9, month 10, month 11, month 12,month 14,early termination visit (occurs only if subject discontinues form study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1,month2,month 3, month 4, month 5, month 6, month 7, month 8,month 9, month 10, month 11, month 12,month 14,early termination visit (occurs only if subject discontinues form study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AA hair loss as assessed by the SALT score

AA hair loss as assessed by the number of subjects with at least 50% improvement in the SALT score as assessed by the Severity of alopecia tool (SALT)

Change in AA hair loss as assessed by the Severity of alopecia tool (SALT)

+9 more

Secondary study objectives

AA as assessed by the Patient's Global Impression of Change (PGI-C) scale

Number of subjects with greatly improved AA as assessed by the Patient's Global Impression of Change (PGI-C) scale

Number of subjects with moderately improved AA as assessed by the Patient's Global Impression of Change (PGI-C) scale

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: 4 months Placebo, then 8 months SADBE 5%Experimental Treatment2 Interventions

Group II: 12 months SADBE 5%Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alopecia Areata, such as Squaric Acid Dibutylester (SADBE), work by modulating the immune response. SADBE induces a mild allergic reaction that helps to reduce the autoimmune attack on hair follicles, which is the underlying cause of hair loss in Alopecia Areata. This immune modulation is crucial as it can halt or reverse the hair loss process. Other treatments, like JAK inhibitors, also target immune pathways to reduce inflammation and autoimmunity, thereby promoting hair regrowth. These mechanisms are essential for managing the autoimmune nature of Alopecia Areata and improving patient outcomes.

Discoid lupus erythematosus exacerbated by contact dermatitis caused by use of squaric acid dibutylester for topical immunotherapy in a patient with alopecia areata.Normalisation of hair follicle morphology in C3H/HeJ alopecia areata mice after treatment with squaric acid dibutylester.Successful treatment of alopecia areata-like hair loss with the contact sensitizer squaric acid dibutylester (SADBE) in C3H/HeJ mice.