The aim of this study is to determine whether topical crisaborole improves hair growth in alopecia areata.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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
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
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, United States
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).
Time frame: 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).
Time frame: Baseline to Week 24
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 24