Clinical Trial on the Efficacy of Intralesional Triamcinolone Versus Candida Albicans Antigen in Treating Alopecia Areata

Not Applicable

Recruiting

• Conditions: Alopecia Areata
• Interventions: Drug: Candida Albicans Antigen Injection

• Registration Number: NCT06564805
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

Brief Summary

The efficacy of two intralesional treatment modalities for alopecia areata will be determined. Thirty patients over the age of 6 with the diagnosis of alopecia areata on the scalp, with an extension of less than 50%, will be included. A comparison will be made between the effectiveness of intralesional Triamcinolone (standard first-line treatment) and intralesional Candida albicans antigen, with serial clinical and trichoscopic pictures at follow-up to evaluate the clinical response and associated adverse effects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study Start: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of alopecia areata
• SALT score of less than 50% extension
• Has not received any topical or systemic treatment in the last month
• Signed informed consent

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Exclusion Criteria

• Any skin condition on the scalp (infectious, inflammatory or neoplastic) that could modify the clinical of trichoscopic features
• Pregnancy or breast-feeding
• Patients in medications that could cause hair loss as side-effects

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intralesional Triamcinolone	Candida Albicans Antigen Injection	Triamcinolone acetonide will be administered intralesionally at a concentration of 4 mg/mL. The solution will be injected in 0.1 mL doses, spaced 1 cm apart. The maximum total dose per session will be limited to 3 mL
Candida albicans antigen	Candida Albicans Antigen Injection	Single subcutaneous administration of 0.1 mL of Candida albicans antigen into one of the alopecic patches

Primary Outcome Measures

Name	Time	Method
Treatment response	5 months	porcentage of hair growth determined by SALT score

Secondary Outcome Measures

Name	Time	Method
Side effects	5 months	Side effects associated to the treatment

Trial Locations

Locations (1)

Hospital Universitario "Dr. José Eleuterio González"; 🇲🇽 Monterrey, Nuevo León, Mexico