Formulation effect in patients with Alopecia Areata
Phase 2
Recruiting
- Conditions
- Alopecia areataAlopecia in AreasC17.800.329.937.122.147
- Registration Number
- RBR-79z2sh
- Lead Sponsor
- Hospital Regional da Asa Norte - HRA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Male or female patients; aged between 18 and 65 years; confirmed clinical diagnosis of alopecia areata; Not responding to previous treatments for alopecia; Not being treated for alopecia for at least 6 months; Female pattern of alopecia with Ludwig grade II or higher; Absence of telogen effluvium in the last 6 months; Not allergic to any compound of the formulations
Exclusion Criteria
Hyper or hypothyroidism diagnosed during the study or decompensated; FAN greater than or equal to 1:320; Serum ferritin less than 40 ng/mL; Contraindications to the use of clobetasol propionate; Pre-treatment (within 6 months) with any of the active substances: Minoxidil hydrochloride and Finasteride.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected outcome: increase in capillary density. Pre- and post-intervention dermatoscopy will be performed and randomly numbered photos will be evaluated by at least three blind specialists. The SALT SCORE will be calculated before and after treatment, and the change from the overall A0 score (worsening or no improvement) to at least A1 (1-25% hair growth recovery) is considered a positive outcome.
- Secondary Outcome Measures
Name Time Method Expected outcome: perception of improvement among the research patients verified by interview at the end of the treatment. The patient will be questioned about the improvement in hair growth and improvement in quality of life, with a score from 1 to 5, being 4 and 5 indicative of a positive outcome.