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Topical Crisaborole in Patients With Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04299503
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
The aim of this study is to determine whether topical crisaborole improves hair growth in alopecia areata.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Crisaborole Topical Ointment Drug: Placebo Topical Ointment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-Blind Period: Weeks 0-12; Open-Label Period: Weeks 12-24
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All site staff will be masked with the exception of pharmacy staff
Primary Purpose: Treatment
Official Title: Phase 2 Double Blind Randomized Placebo Controlled Trial of Topical Crisaborole in Patients With Mild-to-Moderate Alopecia Areata
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Crisaborole

Arm Intervention/treatment
Active Comparator: Crisaborole
ointment applied topically in the morning and in the evening
Drug: Crisaborole Topical Ointment
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
Other Name: Eucrisa

Placebo Comparator: Placebo
ointment applied topically in the morning and in the evening
Drug: Placebo Topical Ointment
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
Other Name: Placebo




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. Severity of Alopecia Tool (SALT)50 Response Double-Blind Period [ Time Frame: Week 6 and Week 12 ]
    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).

  2. Severity of Alopecia Tool (SALT)50 Response Open-Label Period [ Time Frame: Week 24 ]
    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).

  3. Severity of Alopecia Tool (SALT)90 Response Double-Blind Period [ Time Frame: Week 6 and Week 12 ]
    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).

  4. Severity of Alopecia Tool (SALT)90 Response Open-Label Period [ Time Frame: Week 24 ]
    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).

  5. alopecia areata Physician Global Assessment (aaPGA) Double-Blind Period [ Time Frame: Week 6 and Week 12 ]
    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)

  6. alopecia areata Physician Global Assessment (aaPGA) Open-Label Period [ Time Frame: Week 24 ]
    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)

  7. Alopecia Areata Symptom Impact Scale (AASIS) Double-Blind Period [ Time Frame: Week 6 and Week 12 ]
    percent change from Baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 6 and Week 12

  8. Alopecia Areata Symptom Impact Scale (AASIS) Open-Label Period [ Time Frame: Week 24 ]
    percent change from Baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 24

  9. Dermatology Life Quality Index (DLQI) Double-Blind Period [ Time Frame: Week 6 and Week 12 ]
    Percent change from Baseline in the Dermatology Life Quality Index (DLQI) at Week 6 and Week 12

  10. Dermatology Life Quality Index (DLQI) Open-Label Period [ Time Frame: Week 24 ]
    Percent change from Baseline in the Dermatology Life Quality Index (DLQI) at Week 24



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent document indicating the subject has been informed of all aspects of the study.
  2. Subject is willing and able to comply with scheduled visits, treatment plan, study drug administration, and other study procedures.
  3. Clinical diagnosis of alopecia areata with at least one lesion 1 cm in diameter and no more than 20% of total scalp surface area.
  4. 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.
  5. If receiving concomitant medications for any reason, must be on a stable regimen and willing to stay on a stable regimen.
  6. 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:

    • 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

Exclusion Criteria:

  1. 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).
  2. 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.
  3. 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.
  4. Have a history of infection requiring parenteral or oral or topical antimicrobial therapy within 2 weeks prior to baseline.
  5. Received a prohibited concomitant medication within 7 days or 5 half-lives (whichever is longer) prior to baseline visit.
  6. Subjects who have had an allergic reaction (e.g. urticarial, anaphylactic) to crisaborole will be excluded.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299503


Contacts
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Contact: Nicole M Dumont 617 636 7462 ndonovan1@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center, Department of Dermatology Recruiting
Boston, Massachusetts, United States, 02111
Contact: Nicole Dumont    617-636-7462    ndonovan1@tuftsmedicalcenter.org   
Principal Investigator: David Rosmarin, MD         
Sponsors and Collaborators
Tufts Medical Center
Pfizer
Investigators
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Principal Investigator: David Rosmarin, MD Tufts Medical Center
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT04299503    
Other Study ID Numbers: 13289
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical