Topical Crisaborole in Patients with Alopecia Areata

NCT04299503 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 13289
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline to Week 24

Secondary Outcomes (10)

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

  Week 6 and Week 12

• Severity of Alopecia Tool (SALT)50 Response Open-Label Period

  Week 24

• Severity of Alopecia Tool (SALT)90 Response Double-Blind Period

  Week 6 and Week 12

• Severity of Alopecia Tool (SALT)90 Response Open-Label Period

  Week 24

• alopecia areata Physician Global Assessment (aaPGA) Double-Blind Period

  Week 6 and Week 12

Study Arms (2)

Crisaborole

ACTIVE COMPARATOR

ointment applied topically in the morning and in the evening

Drug: Crisaborole Topical Ointment

Placebo

PLACEBO COMPARATOR

ointment applied topically in the morning and in the evening

Drug: Placebo Topical Ointment

Interventions

Crisaborole Topical Ointment DRUG

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

Also known as: Eucrisa

Crisaborole

Placebo Topical Ointment DRUG

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center, Department of Dermatology

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Rosmarin, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All site staff will be masked with the exception of pharmacy staff
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-Blind Period: Weeks 0-12; Open-Label Period: Weeks 12-24

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: March 6, 2020
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 28, 2024

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)