MedPath

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

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.

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
AA epidemiology, presentation, natural history, management, and outcomes
Secondary Outcome Measures
NameTimeMethod
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
© Copyright 2025. All Rights Reserved by MedPath