The purpose of this study is to evaluate the efficacy and safety of SHAPE Gel applied topically to adult patients with alopecia areata of the scalp.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Response evaluated using modified Severity of Alopecia Tool (mSALT)
Severity of Alopecia Tool (SALT) estimates percent scalp hair loss and percent regrowth of hair following intervention
Time frame: Every 4 weeks; up to 24 weeks
Effects on quality of life using Subject Assessment of Hair Loss (SAHL)
The SAHL compares baseline hair volume and hair density with end of treatment hair volume and density
Time frame: Every 4 weeks; up to 24 weeks
Effects on quality of life using Alopecia Areata Symptom Impact Scale (AASIS)
AASIS rates the severity of alopecia areata symptoms and interference of alopecia areata with daily functioning
Time frame: Every 4 weeks; up to 24 weeks
Effects on quality of life using the Skindex-16
Skindex-16 assesses how often symptoms or signs of alopecia areata have been bothersome
Time frame: Every 4 weeks; up to 24 weeks
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Evaluation of safety and tolerability will be assessed through adverse events (AEs), vital signs, physical examination, assessment of local skin changes and changes in clinical laboratory parameters
Time frame: Every 4 weeks, up to 12 weeks
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