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

NCT ID: NCT05414266

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2024-05-22

Brief 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

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

4 months Placebo, then 8 months SADBE 5%

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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.

SADBE 5%

Intervention Type: DRUG

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.

12 months SADBE 5%

Group Type: EXPERIMENTAL

SADBE 5%

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Evidence of a personally signed and dated informed consent document indicating that the participant or a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• not pregnant or breast feeding
• Participants who are women of child bearing potential(WOCBP) must agree to use one highly effective method of contraception(with a failure rate of <1% per year during the intervention period and for at least 28 days after the last dose of study intervention.
• Negative highly sensitive pregnancy (urine) at the Day 1 visit before the first dose of study intervention for WOCBP
• Have a clinical diagnosis of AA with no other etiology of hair loss (e.g., telogen effluvium,androgenetic alopecia, etc.)
• greater than 10% hair loss of the scalp, including without evidence of terminal hair regrowth within 6 months at both screening and baseline visits
• Current episode of hair loss less than 5 years.
• must be on a stable regimen of permitted concomitant medication
• Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources in the treatment area during the study.

Exclusion Criteria

• Other scalp disease that may impact AA assessment (e.g., scalp psoriasis, dermatitis, etc).
• Active systemic diseases that may cause hair loss (e.g., lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).
• Any psychiatric condition including recent or active suicidal ideation or behavior
• Ongoing or recent history of any other uncontrolled and/or clinically significant medical or psychiatric disease or condition which, in the PI's medical opinion, should exclude participation in the study.
• Any present malignancies or history of malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
• History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster
• History of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1
• Known primary or secondary immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency
• Significant trauma or major surgery within 1 month of the first dose of study intervention.
• Considered in imminent need for surgery. Participants with elective surgery scheduled can only be enrolled in Study SADBE-high dose (HD) with the approval of the investigator.
• Participant has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the study intervention
• Anticipated treatment with prohibited concomitant medication(s) during the course of the study
• Received Herbal medications with either unknown properties or pharmaceutical properties that impact AA within 1 week of first dose of study intervention
• Received topical steroids (e.g., steroid cream, steroid ointment) on areas under assessment (i.e., scalp, eyebrows). within 2 week of first dose of study intervention
• Received Ultraviolet B (UVB) phototherapy, Psoralen Ultraviolet A (PUVA) therapy, other phototherapy, contact immunotherapy [e.g.diphenylcyclopropenone (DPCP), and 1-chloro-2,4-dinitrobenzene (DNCB)], topical irritants(e.g., anthralin), and liquid nitrogen cryotherapy within 4 weeks of first dose of study intervention
• Received Other topical or systemic treatments that could affect AA including: Immune suppressants (e.g., cyclosporine A, azathioprine, methotrexate (MTX), sulfasalazine, mycophenolate mofetil (MMF), everolimus, ibrutinib, Intralesional, topical, oral, or injectable (intramuscular or intraarticular)steroids or Oral or topical minoxidil within 8 weeks of first dose of study intervention or within 5 half-lives (if known), whichever is longer
• Received Any Janus kinase (JAK) inhibitor for use in any disease indication or other immunomodulatory biologic agents within 12 weeks of first dose of study intervention or 5 half-lives (if known), whichever is longer
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are University of Texas employees, including their family members, directly involved in the conduct of the study.
• 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.
• Have an active history of alcohol or substance abuse within 1 year prior to Day 1.
• Participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Adelaide Hebert

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adelaide Hebert, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adelaide A Hebert, MD

Role: CONTACT

Adelaide.A.Hebert@uth.tmc.edu

713-500-8276

Eugenio G Galindo, MD

Role: CONTACT

Eugenio.G.Galindo@uth.tmc.edu

713-500-8278

Facility Contacts

Adelaide A Hebert, MD

Role: primary

Adelaide.A.Hebert@uth.tmc.edu

713-500-8276

Eugenio G Galindo, MD

Role: backup

Eugenio.G.Galindo@uth.tmc.edu

713-500-8278

Other Identifiers

HSC-MS-21-1035

Identifier Type: -

Identifier Source: org_study_id