Alopecia AreataPhase 2NCT04556734

Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata

A Phase 2 study testing Etrasimod in people with Alopecia Areata, run by Pfizer at 42 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Alopecia Areata
What is being tested?: Etrasimod
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 42 sitesin 2 countries
Study dates: 29 Jul 2020to 7 Jun 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women between ≥18 and ≤70 years of age at the time of informed consent
Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and <95 at Screening and Day 1/Baseline.
Current episode of hair loss for ≥6 months but <5 years
Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study

Who cannot join

History of male or female pattern hair loss >Hamilton stage III or >Ludwig stage II
Other types of alopecia (eg, cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss
Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors

Trial locations and contacts

42 sites in 2 countries.

Country

City, postcode or hospital

42 sites in 2 countries

United States39 sites

Dermatology Trial Associates
Bryant, Arkansas, 72022
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Advanced Sleep & Respiratory Institute, PA
Daytona Beach, Florida, 32117
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
First OC Dermatology
Fountain Valley, California, 92708
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Eye Surgeons of Indiana
Indianapolis, Indiana, 46260
University of California,Irvine
Irvine, California, 92697
Magnante Eye Care (Ophthalmological Assessments)
Lafayette, Indiana, 47905
Prospect Optometry
Lomita, California, 90717
Torrance Clinical Research Institute,Inc.
Lomita, California, 90717
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Yale Eye Center
New Haven, Connecticut, 06511
Yale Investigational Drug Services
New Haven, Connecticut, 06511
Yale Center for Clinical Investigation
New Haven, Connecticut, 06519
Yale New Haven Hospital Department of Respiratory Care
New Haven, Connecticut, 06519
NYC Retina- Manhattan
New York, New York, 10003
Bobby Buka MD, PC
New York, New York, 10012
Physicians Research Group (Administrative Office Location)
Noblesville, Indiana, 46060
International Eye Associates
Ormond Beach, Florida, 32174
Leavitt Medical Associates of Florida d/ba Ameriderm Research
Ormond Beach, Florida, 32174
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
NW Dermatology Institute
Portland, Oregon, 97210
Rochester Ophthalmological Group
Rochester, New York, 14623
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Lawrence J. Green, MD LLC
Rockville, Maryland, 20850
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Progressive Clinical Research, PA
San Antonio, Texas, 78213
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Investigate MD
Scottsdale, Arizona, 85255
Dermatology Specialists of Spokane
Spokane, Washington, 99202
PRINCIPLE RESEARCH SOLUTIONS (pulmonary function testing)
Spokane, Washington, 99204
SPOKANE EYE CLINIC (OCT and optical exam
Spokane, Washington, 99204
Advanced Clinical Research Institute
Tampa, Florida, 33607
Physicians Research Group
West Lafayette, Indiana, 47906
Randall Dermatology, PC
West Lafayette, Indiana, 47906
WDC Cosmetic and Research, PLLC
Wilmington, North Carolina, 28405

Other trials in United States

Canada3 sites

Dermatology Research Institute
Calgary, Alberta, T2J 7E1
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, T5J 3S9
Innovaderm Research
Montreal, Quebec, H2X 2V1

Other trials in Canada

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata

The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).

Conditions: Alopecia Areata
Being tested: Etrasimod, Placebo
Keywords: T-cell-mediated autoimmune skin disorder, Alopecia areata, Alopecia, APD334, Etrasimod, Hair loss
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.

EtrasimodDrug
Also called APD334
Etrasimod 2 mg tablet by mouth, once daily
EtrasimodDrug
Also called APD334
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
PlaceboDrug
Etrasimod matching placebo tablet by mouth, once daily

Study groups in NCT04556734
Study group	Role	What they receive
Etrasimod 2 mg	Experimental	Not described Receives: Drug: Etrasimod
Etrasimod 3 mg	Experimental	Not described Receives: Drug: Etrasimod
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.
Measured: DB Treatment Period: Baseline (before dose on Day 1), Week 24

Secondary outcomes (2)

Change From Baseline in SALT I at Week 24: DB Treatment Period
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Change from baseline in SALT I is reported in terms of Least square mean and standard error.
Measured: DBT Period: Baseline, Week 24
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for alopecia areata (AA). Investigator determine the percent scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total percent scalp hair loss with a maximum score of 100. Score range from 0 to 100, where 0 =no scalp hair loss to 100 = complete scalp hair loss, higher scores indicated more scalp hair loss. Percentage of participants who achieved >=30%, >=50%, >=75% improvement from baseline in SALT I at Week 24 was reported in this outcome measure.
Measured: DB Treatment Period: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 20207 Jun 2023

First posted21 Sep 2020
Study start29 Jul 2020
Primary completion7 Jun 2023
Study completion7 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Alopecia AreataStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-Blind, Placebo-Controlled
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04556734
Sponsor's protocol ID: APD334-205
Other IDs: C5041008
Status last verified: May 2024
First submitted: 15 Sep 2020
Last updated: 26 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

King B, Mesinkovska N, Senna M, Luo X, Minkiewicz J, Selfridge A. Efficacy and safety of etrasimod in alopecia areata: A multicentre, randomized, double-blind, placebo-controlled, Phase 2 study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1174-1184. doi: 10.1111/jdv.20605. Epub 2025 Mar 27.
PubMed 40145547
Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.
PubMed 39575597

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata

All Alopecia Areata trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata
ClinicalTrials.gov ID: NCT04556734
Acronym / sponsor ID: APD334-205
Conditions: Alopecia Areata
Keywords: T-cell-mediated autoimmune skin disorder, Alopecia areata, Alopecia, APD334, Etrasimod, Hair loss
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Arena is a wholly owned subsidiary of Pfizer
Study start: 29 Jul 2020 (actual)
Primary completion: 7 Jun 2023 (actual)
Study completion: 7 Jun 2023 (actual)
First posted: 21 Sep 2020 (actual)
Results: Posted 26 Jun 2024

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 safety and efficacy of etrasimod monotherapy (2 milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3
Model description: Double-Blind, Placebo-Controlled

Arm	Type	Receives
Etrasimod 2 mg	Experimental	Drug: Etrasimod
Etrasimod 3 mg	Experimental	Drug: Etrasimod
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Men or women between ≥18 and ≤70 years of age at the time of informed consent
Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and <95 at Screening and Day 1/Baseline.
Current episode of hair loss for ≥6 months but <5 years
Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study

Key exclusion criteria (4 listed)

History of male or female pattern hair loss >Hamilton stage III or >Ludwig stage II
Other types of alopecia (eg, cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss
Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors

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
EtrasimodAlso: APD334Etrasimod 2 mg tablet by mouth, once daily	Drug	Etrasimod 2 mg
EtrasimodAlso: APD334Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily	Drug	Etrasimod 3 mg
PlaceboEtrasimod matching placebo tablet by mouth, once daily	Drug	Placebo

Primary outcome

Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period
Time frame: DB Treatment Period: Baseline (before dose on Day 1), Week 24
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.

2 secondary outcomes

Change From Baseline in SALT I at Week 24: DB Treatment Period
Time frame: DBT Period: Baseline, Week 24
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period
Time frame: DB Treatment Period: Baseline, Week 24

Results and safety

Results posted to the registry on 26 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DB Treatment Period: Etrasimod 2 mg	31	24
DB Treatment Period: Etrasimod 3 mg	25	24
DB Treatment Period: Placebo	24	17
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]	0	0
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]	0	0
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]	0	0
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]	0	0
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]	0	0

Primary outcome: Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period

Time frame: DB Treatment Period: Baseline (before dose on Day 1), Week 24. Least squares mean (Standard Error). Unit: Percent change of scalp surface area

Measure	DB Treatment Period: Etrasimod 2 mg n = 16	DB Treatment Period: Etrasimod 3 mg n = 24	DB Treatment Period: Placebo n = 13
Value	-13.79 (8.557)	-21.43 (6.926)	0.35 (8.933)

DB Treatment Period: Etrasimod 2 mg vs DB Treatment Period: Placebo: LS Mean Difference: -14.14 (95% CI -38.933 to 10.648), p = 0.2579, Mixed Models Analysis
DB Treatment Period: Etrasimod 3 mg vs DB Treatment Period: Placebo: LS Mean Difference: -21.79 (95% CI -44.446 to 0.871), p = 0.0592, Mixed Models Analysis

Population analysed: DB treatment period's full analysis set (FAS) included all randomized participants with a SALT I less than (\<) 95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DB Treatment Period: Etrasimod 2 mg	0 of 31 (0%)	11 of 31 (35.5%)	0 of 31
DB Treatment Period: Etrasimod 3 mg	0 of 25 (0%)	12 of 25 (48%)	0 of 25
DB Treatment Period: Placebo	0 of 23 (0%)	11 of 23 (47.8%)	0 of 23
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]	1 of 4 (25%)	3 of 4 (75%)	0 of 4
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]	0 of 4 (0%)	2 of 4 (50%)	0 of 4
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]	1 of 24 (4.2%)	14 of 24 (58.3%)	0 of 24
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]	0 of 20 (0%)	11 of 20 (55%)	0 of 20
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]	0 of 13 (0%)	11 of 13 (84.6%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40145547King B, Mesinkovska N, Senna M, Luo X, Minkiewicz J, Selfridge A. Efficacy and safety of etrasimod in alopecia areata: A multicentre, randomized, double-blind, placebo-controlled, Phase 2 study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1174-1184. doi: 10.1111/jdv.20605. Epub 2025 Mar 27.
Derived from this study: PubMed 39575597Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Alopecia Areata

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
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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.

Pfizer CT.gov Call Center study director

Pfizer

42 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etrasimod in people with Alopecia Areata, run by Pfizer at 42 sites in 2 countries.

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period (time frame: DB Treatment Period: Baseline (before dose on Day 1), Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04556734, which also lists 2 linked publications.

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 26 Jun 2024.