Topical Crisaborole in Patients With Alopecia Areata

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Brief Title

Topical Crisaborole in Patients With Alopecia Areata

Official Title

Phase 2 Double Blind Randomized Placebo Controlled Trial of Topical Crisaborole in Patients With Mild-to-Moderate Alopecia Areata

Brief Summary

      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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Severity of Alopecia Tool (SALT) Score Double-Blind Period

Secondary Outcome

 Severity of Alopecia Tool (SALT)50 Response Double-Blind Period

Condition

Alopecia Areata

Intervention

Crisaborole Topical Ointment

Study Arms / Comparison Groups

 Crisaborole
Description:  ointment applied topically in the morning and in the evening

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

March 6, 2020

Completion Date

December 2021

Primary Completion Date

March 2021

Eligibility 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.
      

Gender

All

Ages

2 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David Rosmarin, MD, 617 636 7462, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04299503

Organization ID

13289


Responsible Party

Sponsor

Study Sponsor

Tufts Medical Center

Collaborators

 Pfizer

Study Sponsor

David Rosmarin, MD, Principal Investigator, Tufts Medical Center


Verification Date

March 2020