SADBE 5% for Alopecia Areata
Phase-Based Progress Estimates
Effectiveness
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Alopecia Areata+1 More
SADBE 5% - DrugEligibility
< 65
All Sexes
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Eligibility
< 65
All Sexes
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Study 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
Eligible Conditions
- Alopecia Areata
Treatment Effectiveness
Effectiveness Progress
Study Objectives
12 Primary · 6 Secondary · Reporting Duration: 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)
Month 14
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)
Number of participants with hair loss as described as a 1-point decrease in the Clinician Global Impression - Alopecia Areata (CGI-AA)
Number of participants with hair loss as described as a 2-point decrease in the Clinician Global Impression - Alopecia Areata (CGI-AA)
Number of subjects that achieved a 1-point increase in eyebrow assessment as assessed by the eyebrow assessment (EBA) score on the right side
Number of subjects that achieved a 2-point increase in eyebrow assessment as assessed by the eyebrow assessment (EBA) score on the left side
Overall hair loss as assessed by the SALT score
Overall 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)
Month 14
Change in AA hair loss as assessed by the Severity of alopecia tool (SALT)
Change in overall hair loss as assessed by the Severity of alopecia tool (SALT)
Month 12
Quality of life as assessed by the Alopecia Areata Quality of Life Index (AA-QLI)
Quality of life as assessed by the Children's Dermatology Life Quality Index (CDLQI)
Quality of life as assessed by the Dermatology Life Quality Index( DLQI)
Month 14
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
Month 12
Hair loss as assessed by number of subjects that score <30 on the the Severity of alopecia tool (SALT)
month 4
Hair loss as assessed by the number of subjects that score <50 on the the Severity of alopecia tool (SALT)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
4 months Placebo, then 8 months SADBE 5%
1 of 2
12 months SADBE 5%
1 of 2
Experimental Treatment
36 Total Participants · 2 Treatment Groups
Primary Treatment: SADBE 5% · Has Placebo Group · Phase < 1
4 months Placebo, then 8 months SADBE 5%Experimental Group · 2 Interventions: Placebo, SADBE 5% · Intervention Types: Drug, Drug
12 months SADBE 5%
Drug
Experimental Group · 1 Intervention: SADBE 5% · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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)
Closest Location: The University of Texas Health Science Center at Houston · Houston, TX
2008First Recorded Clinical Trial
3 TrialsResearching Alopecia Areata
190 CompletedClinical Trials
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
785 Previous Clinical Trials
245,507 Total Patients Enrolled
Adelaide Hebert, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
640 Total Patients Enrolled
Eligibility Criteria
Age < 65 · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have been informed of all pertinent aspects of the study.\n
You are willing and able to comply with the study procedures.
You have a clinical diagnosis of AA with no other etiology of hair loss.
You must not use tanning booths, sun lamps or other ultraviolet light sources in the treatment area during the study.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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