Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can fall out on the scalp or elsewhere on the face and body. Alopecia areata is an autoimmune skin disease, which means that the immune system is recognizing the hair follicles as foreign and attacking them, causing round patches of hair loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss (alopecia universalis). The scalp is the most commonly affected area, but the beard or any hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in males and females of all ages, and is a highly unpredictable condition that tends to recur. Alopecia areata can cause significant distress to both patients and their families. Aim: To assess the effects of a new treatment called secukinumab in patients with alopecia areata. A total of 30 patients will be included in the study, which will run for a total of 28 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50
Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24
Time frame: Week 24
Number of Subjects Achieving a SALT Score of 90 at Week 24
We assessed the Number of subjects that achieved a SALT score of 90 at week 24
Time frame: week 24
Number of Subjects Achieving a SALT Score of 90 at Week 28
We assessed the Number of subjects that achieved a SALT score of 90 at Week 28
Time frame: week 28
Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above
Number of subjects achieving a Physician's Global Assessment (PGA) 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
Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above
Number of subjects achieving a DLQI (Dermatology Life Quality Index), patient global assessment 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
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