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

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document indicating thatthe participant or a legally acceptable representative/parent(s)/legal guardian hasbeen 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 onehighly effective method of contraception(with a failure rate of <1% per year duringthe intervention period and for at least 28 days after the last dose of studyintervention.
• Negative highly sensitive pregnancy (urine) at the Day 1 visit before the first doseof study intervention for WOCBP
• Have a clinical diagnosis of AA with no other etiology of hair loss (e.g., telogeneffluvium,androgenetic alopecia, etc.)
• greater than 10% hair loss of the scalp, including without evidence of terminal hairregrowth 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, sunlamps 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 significantmedical or psychiatric disease or condition which, in the PI's medical opinion, shouldexclude participation in the study.
• Any present malignancies or history of malignancies with the exception of adequatelytreated or excised non metastatic basal cell or squamous cell cancer of the skin orcervical 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 antimicrobialtherapy, or as otherwise judged clinically significant by the investigator within 6months prior to Day 1
• Known primary or secondary immunodeficiency disorder or a first-degree relative with ahereditary immunodeficiency
• Significant trauma or major surgery within 1 month of the first dose of studyintervention.
• Considered in imminent need for surgery. Participants with elective surgery scheduledcan only be enrolled in Study SADBE-high dose (HD) with the approval of theinvestigator.
• Active acute or chronic infection requiring treatment with oral antibiotics,antivirals, anti-parasitics, anti-protozoals, or antifungals within 4 weeks prior toDay 1 or any active systemic or local infection not meeting other exclusion criteriawithin 1 week prior to Day 1.
• Participant has a known hypersensitivity or previous allergic reaction to any of theactive or inactive ingredients in the study intervention
• Anticipated treatment with prohibited concomitant medication(s) during the course ofthe study
• Received Herbal medications with either unknown properties or pharmaceuticalproperties that impact AA within 1 week of first dose of study intervention
• Received topical steroids (e.g., steroid cream, steroid ointment) on areas underassessment (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 liquidnitrogen cryotherapy within 4 weeks of first dose of study intervention
• Received Other topical or systemic treatments that could affect AA including: Immunesuppressants (e.g., cyclosporine A, azathioprine, methotrexate (MTX), sulfasalazine,mycophenolate mofetil (MMF), everolimus, ibrutinib, Intralesional, topical, oral, orinjectable (intramuscular or intraarticular)steroids or Oral or topical minoxidilwithin 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 otherimmunomodulatory biologic agents within 12 weeks of first dose of study interventionor 5 half-lives (if known), whichever is longer
• Investigator site staff members directly involved in the conduct of the study andtheir family members, site staff members otherwise supervised by the investigator, orparticipants 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 areasonable 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 tolanguage problems, poor mental development, or impaired cerebral function.