Alopecia AreataEarly Phase 1NCT05414266
Study Evaluating Efficacy of Topical Squaric Acid Dibutyl Ester in Children and Adolescents With Alopecia Areata
A Early Phase 1 study testing SADBE 5% in people with Alopecia Areata, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- SADBE 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 22 May 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.)
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
- Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, anti-parasitics, anti-protozoals, or antifungals within 4 weeks prior to Day 1 or any active systemic or local infection not meeting other exclusion criteria within 1 week prior to Day 1.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Adelaide A Hebert, MD, 713-500-8276, Adelaide.A.Hebert@uth.tmc.edu
Eugenio G Galindo, MD, 713-500-8278, Eugenio.G.Galindo@uth.tmc.edu
About this study
Official title: A Randomized, Placebo Controlled Single Site Study Evaluating Efficacy of Topical Squaric Acid Dibutyl Ester in Children and Adolescents With Alopecia Areata
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
- Being tested
- Placebo, SADBE 5%
- Keywords
- Alopecia
- Medical subject headings
- Alopecia Areata, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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%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.
| Study group | Role | What they receive |
|---|---|---|
| 4 months Placebo, then 8 months SADBE 5% | Experimental | Not described Receives: Drug: Placebo; Drug: SADBE 5% |
| 12 months SADBE 5% | Experimental | Not described Receives: Drug: SADBE 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair loss as assessed by number of subjects that score <30 on the the Severity of alopecia tool (SALT)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively.
Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Measured: end of treatment (12 months of treatment)
Hair loss as assessed by the number of subjects that score <50 on the the Severity of alopecia tool (SALT)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively.
Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Measured: month 4
Overall hair loss as assessed by the SALT score
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively.
Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
AA hair loss as assessed by the SALT score
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively.
Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Change in overall hair loss as assessed by the Severity of alopecia tool (SALT)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively.
Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Measured: 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)
Change in AA hair loss as assessed by the Severity of alopecia tool (SALT)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively.
Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Measured: 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)
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)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively.
Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
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)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively.
Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Number of subjects that achieved a 1-point increase in eyebrow assessment as assessed by the eyebrow assessment (EBA) score on the right side
This survey has a rating scale that ranges from 0 (none eyebrow) to 3 (normal eyebrow).This assessment will be performed for participants with eyebrows designated as one of the treatment areas, grading each eyebrow separately.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Number of subjects that achieved a 2-point increase in eyebrow assessment as assessed by the eyebrow assessment (EBA) score on the left side
This survey has a rating scale that ranges from 0 (none eyebrow) to 3 (normal eyebrow).This assessment will be performed for participants with eyebrows designated as one of the treatment areas, grading each eyebrow separately.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Number of participants with hair loss as described as a 1-point decrease in the Clinician Global Impression - Alopecia Areata (CGI-AA)
The Clinician Global Impression - Alopecia Areata (CGI-AA) is a single clinician-reported item developed to assess clinical impression of severity of scalp hair loss. The rater is asked to rate the participant's current hair loss on a 5 point static discrete scale ranging from 0 "None (no hair loss)", 1 "Minimal Hair Loss, 2 "Moderate Hair Loss", 3 "Severe Hair Loss" 4 "Very Severe or complete hair loss" with higher scores indicating more severe hair loss.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Number of participants with hair loss as described as a 2-point decrease in the Clinician Global Impression - Alopecia Areata (CGI-AA)
The Clinician Global Impression - Alopecia Areata (CGI-AA) is a single clinician-reported item developed to assess clinical impression of severity of scalp hair loss. The rater is asked to rate the participant's current hair loss on a 5 point static discrete scale ranging from 0 "None (no hair loss)", 1 "Minimal Hair Loss, 2 "Moderate Hair Loss", 3 "Severe Hair Loss" 4 "Very Severe or complete hair loss" with higher scores indicating more severe hair loss.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Secondary outcomes (6)
AA as assessed by the Patient's Global Impression of Change (PGI-C) scale
The Patient's Global Impression of Change (PGI-C) asks the participant to evaluate the improvement or worsening of their AA as compared to the start of the study using a single-item, "Since the start of the study, my alopecia areata has: …". The participants will select one of seven responses ranging from "greatly improved" to "greatly worsened."
Measured: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Number of subjects with moderately improved AA as assessed by the Patient's Global Impression of Change (PGI-C) scale
The Patient's Global Impression of Change (PGI-C) asks the participant to evaluate the improvement or worsening of their AA as compared to the start of the study using a single-item, "Since the start of the study, my alopecia areata has: …". The participants will select one of seven responses ranging from "greatly improved" to "greatly worsened."
Measured: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Number of subjects with greatly improved AA as assessed by the Patient's Global Impression of Change (PGI-C) scale
The Patient's Global Impression of Change (PGI-C) asks the participant to evaluate the improvement or worsening of their AA as compared to the start of the study using a single-item, "Since the start of the study, my alopecia areata has: …". The participants will select one of seven responses ranging from "greatly improved" to "greatly worsened."
Measured: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Quality of life as assessed by the Dermatology Life Quality Index( DLQI)
The DLQI is a self administered validated questionnaire designed to measure the health-related quality of life of adult patients (greater than 16 years of age)suffering from a skin disease. This survey has 10 questions and each is scored on a 4 point scale from 0(not at all)-3(very much) for a maximum score of 30 and higher scores mean greater impairment of patient's quality of life
Measured: Baseline,Mont4, Month 6, Month 9,Month 12
Quality of life as assessed by the Children's Dermatology Life Quality Index (CDLQI)
CDLQI is designed to measure the impact of any skin disease on the lives of children.This survey has 10 questions and each is scored on a 4 point scale from 0(not at all)-3(very much) for a maximum score of 30 and higher scores mean greater impairment of patient's quality of life
Measured: Baseline,Mont4, Month 6, Month 9,Month 12
Quality of life as assessed by the Alopecia Areata Quality of Life Index (AA-QLI)
This is a 21 item questionnaire asking about whether they have a negative effect from alopecia scored categorically as very much, a lot, a little and not at all.Not at all indicating better quality of life
Measured: Baseline,Mont4, Month 6, Month 9,Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start15 Aug 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion22 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelaide Hebert, The University of Texas Health Science Center, Houston
- Investigators
- Adelaide Hebert, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414266
- Sponsor's protocol ID
- HSC-MS-21-1035
- Status last verified
- Oct 2022
- First submitted
- 7 Jun 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Single Site Study Evaluating Efficacy of Topical Squaric Acid Dibutyl Ester in Children and Adolescents With Alopecia Areata
- ClinicalTrials.gov ID
- NCT05414266
- Acronym / sponsor ID
- HSC-MS-21-1035
- Conditions
- Alopecia Areata
- Keywords
- Alopecia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 22 May 2024 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 months Placebo, then 8 months SADBE 5% | Experimental | Drug: Placebo, Drug: SADBE 5% |
| 12 months SADBE 5% | Experimental | Drug: SADBE 5% |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo 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. | Drug | 4 months Placebo, then 8 months SADBE 5% |
| 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. | Drug | 12 months SADBE 5%, 4 months Placebo, then 8 months SADBE 5% |
Primary outcome
Hair loss as assessed by number of subjects that score <30 on the the Severity of alopecia tool (SALT)
Time frame: end of treatment (12 months of treatment)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Hair loss as assessed by the number of subjects that score <50 on the the Severity of alopecia tool (SALT)
Time frame: month 4
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Overall hair loss as assessed by the SALT score
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
AA hair loss as assessed by the SALT score
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Change in overall hair loss as assessed by the Severity of alopecia tool (SALT)
Time frame: 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)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Change in AA hair loss as assessed by the Severity of alopecia tool (SALT)
Time frame: 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)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
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)
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
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)
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
The SALT measures the percentage of hair loss on the scalp utilizing a visual aid showing the division of the scalp hair into four quadrants (back, top of scalp, and both sides), with each of the four quadrants given an accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Total SALT score is reported and calculated as: Total SALT Score=[0.40x%scalp hair loss top quadrant]+[0.24x%scalp hair loss back quadrant]+[0.18x%scalp hair loss left quadrant]+[0.18x% scalp hair loss right quadrant]
Number of subjects that achieved a 1-point increase in eyebrow assessment as assessed by the eyebrow assessment (EBA) score on the right side
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
This survey has a rating scale that ranges from 0 (none eyebrow) to 3 (normal eyebrow).This assessment will be performed for participants with eyebrows designated as one of the treatment areas, grading each eyebrow separately.
Number of subjects that achieved a 2-point increase in eyebrow assessment as assessed by the eyebrow assessment (EBA) score on the left side
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
This survey has a rating scale that ranges from 0 (none eyebrow) to 3 (normal eyebrow).This assessment will be performed for participants with eyebrows designated as one of the treatment areas, grading each eyebrow separately.
Number of participants with hair loss as described as a 1-point decrease in the Clinician Global Impression - Alopecia Areata (CGI-AA)
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
The Clinician Global Impression - Alopecia Areata (CGI-AA) is a single clinician-reported item developed to assess clinical impression of severity of scalp hair loss. The rater is asked to rate the participant's current hair loss on a 5 point static discrete scale ranging from 0 "None (no hair loss)", 1 "Minimal Hair Loss, 2 "Moderate Hair Loss", 3 "Severe Hair Loss" 4 "Very Severe or complete hair loss" with higher scores indicating more severe hair loss.
Number of participants with hair loss as described as a 2-point decrease in the Clinician Global Impression - Alopecia Areata (CGI-AA)
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
The Clinician Global Impression - Alopecia Areata (CGI-AA) is a single clinician-reported item developed to assess clinical impression of severity of scalp hair loss. The rater is asked to rate the participant's current hair loss on a 5 point static discrete scale ranging from 0 "None (no hair loss)", 1 "Minimal Hair Loss, 2 "Moderate Hair Loss", 3 "Severe Hair Loss" 4 "Very Severe or complete hair loss" with higher scores indicating more severe hair loss.
6 secondary outcomes
AA as assessed by the Patient's Global Impression of Change (PGI-C) scale
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Number of subjects with moderately improved AA as assessed by the Patient's Global Impression of Change (PGI-C) scale
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Number of subjects with greatly improved AA as assessed by the Patient's Global Impression of Change (PGI-C) scale
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8,Month 9, Month 10, Month 11, Month 12(end of treatment),Month 14(end of study),early termination visit (occurs only if subject discontinues form study)
Quality of life as assessed by the Dermatology Life Quality Index( DLQI)
Time frame: Baseline,Mont4, Month 6, Month 9,Month 12
Quality of life as assessed by the Children's Dermatology Life Quality Index (CDLQI)
Time frame: Baseline,Mont4, Month 6, Month 9,Month 12
Quality of life as assessed by the Alopecia Areata Quality of Life Index (AA-QLI)
Time frame: Baseline,Mont4, Month 6, Month 9,Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adelaide Hebert, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SADBE 5% in people with Alopecia Areata, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adelaide A Hebert, MD (713-500-8276, Adelaide.A.Hebert@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair loss as assessed by number of subjects that score <30 on the the Severity of alopecia tool (SALT) (time frame: end of treatment (12 months of treatment)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.