Alopecia AreataPhase 2NCT04299503
Topical Crisaborole in Patients with Alopecia Areata
A Phase 2 study testing Crisaborole Topical Ointment in people with Alopecia Areata, run by Tufts Medical Center at 1 site in United States.
Trial summary
The aim of this study is to determine whether topical crisaborole improves hair growth in alopecia areata. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Crisaborole Topical Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to Dec 2022
- Phase
- Phase 2
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed and dated informed consent document indicating the subject has been informed of all aspects of the study.
- Subject is willing and able to comply with scheduled visits, treatment plan, study drug administration, and other study procedures.
- Clinical diagnosis of alopecia areata with at least one lesion 1 cm in diameter and no more than 20% of total scalp surface area.
- Females of child-bearing potential agree to use a reliable method of birth control or remain absent during the study and for at least 4 weeks following the last dose of the assigned treatment.
- If receiving concomitant medications for any reason, must be on a stable regimen and willing to stay on a stable regimen.
- All treatments for alopecia areata are prohibited during the course of the study. If subjects received any of the following treatments, the minimum criteria are observed:
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- Must be discontinued for at least 12 weeks prior to Baseline:
- o Any investigational or experimental therapy or procedure for alopecia areata;
- Exception: Investigational biologics should be discussed with Sponsor to confirm period of discontinuation required. Must be discontinued for at least 8 weeks prior to Baseline:
- o Laser or light based alopecia areata treatments
- Must be discontinued for at least 4 weeks prior to Baseline:
- Immunomodulating or immunosuppressive oral medications (corticosteroids, methotrexate, cyclosporine, etc.) Subjects who require these medications during the study (e.g. use of corticosteroids for a chronic obstructive pulmonary disease exacerbation) will be terminated from the study.
- Injections of steroids to alopecia areata areas
- Contact sensitization treatment
- Oral minoxidil
- Patients already taking finesteride for at least 3 months to treat conditions in addition to or other than hair loss (benign prostate hypertrophy, hormonal suppression, etc.) may continue on this medication so long as the dose remains stable throughout the study.
- Must be discontinued for at least 2 weeks prior to Baseline:
- Topical treatments that may affect alopecia areata, e.g., corticosteroids, topical tacrolimus/pimecrolimus, retinoids. Use of these medications in non-AA areas, for non-AA conditions is allowed.
- Hair regrowth products containing minoxidil
- Use of any prior and concomitant therapy not listed above which, in the opinion of the PI may interfere with the objective of the study, within 60 days prior to the Screening Visit is prohibited
Who cannot join
- Other skin conditions that, in the opinion of the PI would interfere with evaluation of alopecia areata. Conditions may include other types of hair loss, including discoid lupus, lichen planus pilaris, frontal fibrosing alopecia, cicatricial alopecia, and trichotillomania (hair pulling).
- Pregnant/breastfeeding females, or females of childbearing potential not using highly effective contraception. Women of childbearing potential must test negative for pregnancy and use contraception for at least four weeks after last dose of drug.
- Current or recent history of clinically significant medical or psychiatric condition, which, in the judgment of the principal investigator, may increase risk associated with the study participation or drug administration. Examples include, but are not limited to, recent infections or injuries of the scalp.
- Have a history of infection requiring parenteral or oral or topical antimicrobial therapy within 2 weeks prior to baseline.
- Received a prohibited concomitant medication within 7 days or 5 half-lives (whichever is longer) prior to baseline visit.
- Subjects who have had an allergic reaction (e.g. urticarial, anaphylactic) to crisaborole will be excluded.
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- Participated in a trial for a topical or oral JAK inhibitor. JAK inhibitors are thought to improve alopecia areata, and sometimes the effects of JAK inhibitors can last long after treatment is completed. Past treatment with these agents could confound the results of crisaborole's effectiveness for alopecia.
- Is currently on an oral PDE4 inhibitor or oral JAK inhibitor. PDE4 inhibitors and JAK inhibitors have been theorized to improve alopecia. Treatment with these agents could confound our results on the effectiveness of crisaborole for alopecia areata.
- Have participated in other research studies of investigational products within 4 weeks or 5 half-lives (whichever is longer) of the investigational product prior to baseline. Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
- Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Sponsor employees directly involved in the conduct of the trial.
- In the opinion of the investigator or Sponsor, the subject is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle guidelines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, 02111
About this study
Official title: Phase 2 Double Blind Randomized Placebo Controlled Trial of Topical Crisaborole in Patients with Mild-to-Moderate Alopecia Areata
The aim of this study is to determine whether topical crisaborole improves hair growth in alopecia areata.
Read the detailed description
Each individual will be enrolled in the study for 24 weeks. Following a 28 days screening period, eligible subjects will be randomized in a 1:1 ratio to receive either crisaborole 2% ointment or matching placebo for 12 weeks. The primary endpoint is assessed at week 12. At the week 12 visit, all subjects will enter the open label treatment period where they will all receive crisaborole 2% ointment for an additional 12 weeks, with the last study visit taking place on week 24.
- Conditions
- Alopecia Areata
- Being tested
- Crisaborole Topical Ointment, Placebo Topical Ointment
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisaborole Topical OintmentDrug
Also called Eucrisa
For every 10% of scalp affected, approximately ½ finger tip of study drug will be needed to cover the area with a thin layer. After the first application at baseline, the tubes will be weighed to determine the dose needed to cover the affected area. This will be the subject's target dose throughout the study
Placebo Topical OintmentDrug
Also called Placebo
For every 10% of scalp affected, approximately ½ finger tip of study drug will be needed to cover the area with a thin layer. After the first application at baseline, the tubes will be weighed to determine the dose needed to cover the affected area. This will be the subject's target dose throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole | Active comparator | ointment applied topically in the morning and in the evening Receives: Drug: Crisaborole Topical Ointment |
| Placebo | Placebo comparator | ointment applied topically in the morning and in the evening Receives: Drug: Placebo Topical Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Alopecia Tool (SALT) Score Double-Blind Period
percent change in Severity of Alopecia Tool (SALT) score from baseline to Week 12. The range in score is 0% (no hair loss) to 100% (complete hair loss).
Measured: Baseline to Week 12
Severity of Alopecia Tool (SALT) Open-Label Period
percent change in Severity of Alopecia Tool (SALT) score from baseline to Week 24. The range in score is 0% (no hair loss) to 100% (complete hair loss).
Measured: Baseline to Week 24
Secondary outcomes (10)
Severity of Alopecia Tool (SALT)50 Response Double-Blind Period
Greater than or equal to 50% reduction in Severity of Alopecia Tool (SALT) score response in terminal hair at Week 6 and Week 12. The range in score is 0% (no hair loss) to 100% (complete hair loss).
Measured: Week 6 and Week 12
Severity of Alopecia Tool (SALT)50 Response Open-Label Period
Greater than or equal to 50% reduction in Severity of Alopecia Tool (SALT) score response in terminal hair at Week 24. The range in score is 0% (no hair loss) to 100% (complete hair loss).
Measured: Week 24
Severity of Alopecia Tool (SALT)90 Response Double-Blind Period
Greater than or equal to 90% reduction in Severity of Alopecia Tool (SALT) score response in terminal hair at Week 6 and Week 12. The range in score is 0% (no hair loss) to 100% (complete hair loss).
Measured: Week 6 and Week 12
Severity of Alopecia Tool (SALT)90 Response Open-Label Period
Greater than or equal to 90% reduction in Severity of Alopecia Tool (SALT) score response in terminal hair at Week 24. The range in score is 0% (no hair loss) to 100% (complete hair loss).
Measured: Week 24
alopecia areata Physician Global Assessment (aaPGA) Double-Blind Period
achieving an alopecia areata Physician Global Assessment (aaPGA) score of 3 or above at Weeks 6 and 12; (0 =no regrowth; 1 = <25% of regrowth; 2 = 25%-49% of regrowth; 3 = 50%-74% of regrowth; 4 = 75%-99% of re- growth; 5 = 100% of regrowth)
Measured: Week 6 and Week 12
alopecia areata Physician Global Assessment (aaPGA) Open-Label Period
achieving an alopecia areata Physician Global Assessment (aaPGA) score of 3 or above at Week 24; (0 =no regrowth; 1 = <25% of regrowth; 2 = 25%-49% of regrowth; 3 = 50%-74% of regrowth; 4 = 75%-99% of re- growth; 5 = 100% of regrowth)
Measured: Week 24
Alopecia Areata Symptom Impact Scale (AASIS) Double-Blind Period
percent change from Baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 6 and Week 12
Measured: Week 6 and Week 12
Alopecia Areata Symptom Impact Scale (AASIS) Open-Label Period
percent change from Baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 24
Measured: Week 24
Dermatology Life Quality Index (DLQI) Double-Blind Period
Percent change from Baseline in the Dermatology Life Quality Index (DLQI) at Week 6 and Week 12
Measured: Week 6 and Week 12
Dermatology Life Quality Index (DLQI) Open-Label Period
Percent change from Baseline in the Dermatology Life Quality Index (DLQI) at Week 24
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start6 Mar 2020
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Unable to identify subjects to meet inclusion criteria
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.
- 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
- Crossover
- Model description
- Double-Blind Period: Weeks 0-12; Open-Label Period: Weeks 12-24
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rosmarin, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299503
- Sponsor's protocol ID
- 13289
- Status last verified
- Jan 2022
- First submitted
- 4 Mar 2020
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Double Blind Randomized Placebo Controlled Trial of Topical Crisaborole in Patients with Mild-to-Moderate Alopecia Areata
- ClinicalTrials.gov ID
- NCT04299503
- Acronym / sponsor ID
- 13289
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to identify subjects to meet inclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Mar 2020 (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 aim of this study is to determine whether topical crisaborole improves hair growth in alopecia areata.
Detailed description
Each individual will be enrolled in the study for 24 weeks. Following a 28 days screening period, eligible subjects will be randomized in a 1:1 ratio to receive either crisaborole 2% ointment or matching placebo for 12 weeks. The primary endpoint is assessed at week 12. At the week 12 visit, all subjects will enter the open label treatment period where they will all receive crisaborole 2% ointment for an additional 12 weeks, with the last study visit taking place on week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blind Period: Weeks 0-12; Open-Label Period: Weeks 12-24
| Arm | Type | Receives |
|---|---|---|
| Crisaborole | Active comparator | Drug: Crisaborole Topical Ointmentointment applied topically in the morning and in the evening |
| Placebo | Placebo comparator | Drug: Placebo Topical Ointmentointment applied topically in the morning and in the evening |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Signed and dated informed consent document indicating the subject has been informed of all aspects of the study.
- Subject is willing and able to comply with scheduled visits, treatment plan, study drug administration, and other study procedures.
- Clinical diagnosis of alopecia areata with at least one lesion 1 cm in diameter and no more than 20% of total scalp surface area.
- Females of child-bearing potential agree to use a reliable method of birth control or remain absent during the study and for at least 4 weeks following the last dose of the assigned treatment.
- If receiving concomitant medications for any reason, must be on a stable regimen and willing to stay on a stable regimen.
Key exclusion criteria (11 listed)
- Other skin conditions that, in the opinion of the PI would interfere with evaluation of alopecia areata. Conditions may include other types of hair loss, including discoid lupus, lichen planus pilaris, frontal fibrosing alopecia, cicatricial alopecia, and trichotillomania (hair pulling).
- Pregnant/breastfeeding females, or females of childbearing potential not using highly effective contraception. Women of childbearing potential must test negative for pregnancy and use contraception for at least four weeks after last dose of drug.
- Current or recent history of clinically significant medical or psychiatric condition, which, in the judgment of the principal investigator, may increase risk associated with the study participation or drug administration. Examples include, but are not limited to, recent infections or injuries of the scalp.
- Have a history of infection requiring parenteral or oral or topical antimicrobial therapy within 2 weeks prior to baseline.
- Received a prohibited concomitant medication within 7 days or 5 half-lives (whichever is longer) prior to baseline visit.
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 |
|---|---|---|
| Crisaborole Topical OintmentAlso: EucrisaFor every 10% of scalp affected, approximately ½ finger tip of study drug will be needed to cover the area with a thin layer. After the first application at baseline, the tubes will be weighed to determine the dose needed to cover the affected area. This will be the subject's target dose throughout the study | Drug | Crisaborole |
| Placebo Topical OintmentAlso: PlaceboFor every 10% of scalp affected, approximately ½ finger tip of study drug will be needed to cover the area with a thin layer. After the first application at baseline, the tubes will be weighed to determine the dose needed to cover the affected area. This will be the subject's target dose throughout the study | Drug | Placebo |
Primary outcome
Severity of Alopecia Tool (SALT) Score Double-Blind Period
Time frame: Baseline to Week 12
percent change in Severity of Alopecia Tool (SALT) score from baseline to Week 12. The range in score is 0% (no hair loss) to 100% (complete hair loss).
Severity of Alopecia Tool (SALT) Open-Label Period
Time frame: Baseline to Week 24
percent change in Severity of Alopecia Tool (SALT) score from baseline to Week 24. The range in score is 0% (no hair loss) to 100% (complete hair loss).
10 secondary outcomes
Severity of Alopecia Tool (SALT)50 Response Double-Blind Period
Time frame: Week 6 and Week 12
Severity of Alopecia Tool (SALT)50 Response Open-Label Period
Time frame: Week 24
Severity of Alopecia Tool (SALT)90 Response Double-Blind Period
Time frame: Week 6 and Week 12
Severity of Alopecia Tool (SALT)90 Response Open-Label Period
Time frame: Week 24
alopecia areata Physician Global Assessment (aaPGA) Double-Blind Period
Time frame: Week 6 and Week 12
alopecia areata Physician Global Assessment (aaPGA) Open-Label Period
Time frame: Week 24
Alopecia Areata Symptom Impact Scale (AASIS) Double-Blind Period
Time frame: Week 6 and Week 12
Alopecia Areata Symptom Impact Scale (AASIS) Open-Label Period
Time frame: Week 24
Dermatology Life Quality Index (DLQI) Double-Blind Period
Time frame: Week 6 and Week 12
Dermatology Life Quality Index (DLQI) Open-Label Period
Time frame: Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- 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.
David Rosmarin, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crisaborole Topical Ointment in people with Alopecia Areata, run by Tufts Medical Center 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 20 inclusion and 11 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: withdrawn, as of the sponsor's last update on 28 Oct 2024. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Severity of Alopecia Tool (SALT) Score Double-Blind Period (time frame: Baseline to Week 12). The study lists 2 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 28 Oct 2024.