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

NCT06564805 | Recruiting

• 1 other identifier: DE24-00008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Treatment response

  porcentage of hair growth determined by SALT score

  5 months

Secondary Outcomes (1)

• Side effects

  5 months

Study Arms (2)

intralesional Triamcinolone

ACTIVE COMPARATOR

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

Drug: Candida Albicans Antigen Injection

Candida albicans antigen

EXPERIMENTAL

Single subcutaneous administration of 0.1 mL of Candida albicans antigen into one of the alopecic patches

Drug: Candida Albicans Antigen Injection

Interventions

Candida Albicans Antigen Injection DRUG

subcutaneous administration of Candida albicans antigen

Candida albicans antigen; intralesional Triamcinolone

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fania Muñoz Garza, PhD

  Hospital Universitario "Dr. José E. González"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika Alba-Rojas, MD

CONTACT

+528183891111; eri9ar@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Erika Alba Rojas

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: August 20, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

ME (1)