CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry
- Conditions
- Alopecia Areata
- Registration Number
- NCT06562270
- Lead Sponsor
- CorEvitas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 1500
Inclusion Criteria:<br><br>To be eligible to participate in this registry, an individual must meet all the following<br>criteria:<br><br> 1. Has ever been diagnosed with severe AA by a dermatologist or a qualified dermatology<br> provider.<br><br> 2. Is 12-17 years of age at the time of enrollment.<br><br> 3. Is willing to provide consent/assent for participation in the registry.<br><br> 4. Has been prescribed a new commercially available advanced therapy and/or<br> conventional systemic therapy for the treatment of severe AA in adolescents in the<br> context of routine clinical care that is consistent with local prescribing<br> guidelines and/or regulations for the country where the site is located.<br><br>A new therapy is a medication that the subject has never taken before.<br><br> 1. At the time of registry enrollment OR<br><br> 2. Within 6 months prior to registry enrollment In the opinion of the treating<br> provider, is deemed a candidate for treatment with a commercially available advanced<br> therapy and/or conventional systemic therapy for the treatment of severe AA in<br> adolescents but has not received nor is planning to initiate treatment at the time<br> of registry enrollment.<br><br>Exclusion Criteria:<br><br>An individual who meets any of the following criteria will be excluded from participation<br>in the registry:<br><br> 1. Is participating or planning to participate in a blinded clinical trial for any<br> investigational medication.<br><br> 2. Is unwilling or unable to provide standing height measurements.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AA epidemiology, presentation, natural history, management, and outcomes
- Secondary Outcome Measures
Name Time Method Percentage of patients with history of comorbidities;Patient reported : Hair Concealment Question;Patient reported : Stressful Life Event;Patient reported : Scalp Hair Assessment;Patient reported :Measures for Eye Irritation & Nail Appearance;Patient reported : Numerical Rating Scale for Nasal irritation;Patient reported : Alopecia Areata Patient Priority Outcomes (AAPPO);Patient reported : Patient Health Questionnaire (PHQ);Patient reported :PROMIS Pediatric Sleep Disturbance 4 a;Patient reported : PROMIS Pediatric Stigma 8a;Patient reported : Grief Assessment;Patient reported : Pubertal Tanner Staging;Physician reported : Pubertal Progression: Tanner Staging Assessment;Physician reported : Severity of Alopecia Tool (SALT);Physician reported : Alopecia Areata Investigator Global Assessment Scale (AA-IGA);Physician reported : Measures for Eyebrow & Eyelash Hair loss and Nail Appearance
Related Research Topics
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