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SADBE for Alopecia Areata
Phase < 1
Recruiting
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
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)
Awards & highlights
Study Summary
This trial will test a new medication for alopecia areata, a condition that causes hair loss. The medication will be assessed for efficacy and tolerability in children and adolescents.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,961 Total Patients Enrolled
Adelaide Hebert, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
640 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lost more than 10% of my scalp hair without regrowth in the last 6 months.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.I am not planning to take any medications that are not allowed during the study.I or a close family member have an immune system disorder.I haven't taken antibiotics or antivirals for infections in the last 4 weeks.You have had problems with drinking or using drugs in the past year.You have a mental health condition, including recent thoughts about hurting yourself or others.I do not have any uncontrolled serious health or mental conditions.I have no current cancers except for treated skin cancer or cervical pre-cancer.Before starting the study treatment, a test shows that you are not pregnant.I haven't taken JAK inhibitors or similar drugs recently.I have used topical steroids on the areas being examined within the last 2 weeks.My hair loss started less than 5 years ago.I agree to avoid sun exposure and not use UV light sources during the study.You have had widespread herpes zoster or herpes simplex infections, or have had repeated localized herpes zoster.I do not have any scalp conditions that could affect hair loss evaluation.I have a condition that could cause hair loss.I haven't had a serious infection requiring hospital stay or IV antibiotics in the last 6 months.I have not had major surgery or significant trauma in the last month.I need surgery urgently.I haven't had specific skin treatments like UV therapy or cryotherapy in the last 4 weeks.I have not taken herbal medications that could affect the study drug within the last week.My current medications have not changed recently.I agree to use a highly effective birth control method.I have been diagnosed with alopecia areata and no other cause for my hair loss.I have lost more than 10% of my scalp hair without regrowth in the last 6 months.My hair loss started less than 5 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: 4 months Placebo, then 8 months SADBE 5%
- Group 2: 12 months SADBE 5%
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there particular demographics that would be best suited for this research project?
"This clinical trial is seeking 36 patients aged between 12 and 18 who suffer from alopecia areata. All applicants must meet these criteria in order to be considered for the study."
Answered by AI
How many individuals have agreed to participate in this investigation?
"Affirmative. The information hosted on clinicaltrials.gov informs us that this medical trial, which was first advertised on August 15th 2022, is actively enrolling participants. There are 36 individuals required to join the study at a single site."
Answered by AI
Is this research endeavor still acquiring participants?
"Affirmative. The information found on clinicaltrials.gov confirms that the study, which was first posted on August 15th 2022, is actively seeking participants from a single medical centre and requires 36 patients in total to complete the trial."
Answered by AI
What is the intended outcome of this clinical research?
"This trial will span over the course of a year, with visits at Baseline, Month 1-12 and Early Termination (if applicable). The primary outcome measure is overall hair loss as assessed by the SALT score. As secondary outcomes, this study also evaluates patient's Global Impression of Change (PGI-C) scale to rate moderately or greatly improved AA cases along with quality of life assessment using Children's Dermatology Life Quality Index (CDLQI)."
Answered by AI
Does this research include persons aged 35 and older?
"This clinical trial has specific eligibility requirements, including that participants must be between 12 and 18 years of age. Specifically, 9 trials are available for patients under the legal age of adulthood while 63 studies target seniors over 65."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I've been experiencing hair thinning and hair loss and I would like to act before it gets too late.
PatientReceived 1 prior treatment
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