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

NCT ID: NCT06564805

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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intralesional Triamcinolone

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

Group Type ACTIVE_COMPARATOR

Candida Albicans Antigen Injection

Intervention Type DRUG

subcutaneous administration of Candida albicans antigen

Candida albicans antigen

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

Group Type EXPERIMENTAL

Candida Albicans Antigen Injection

Intervention Type DRUG

subcutaneous administration of Candida albicans antigen

Interventions

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Candida Albicans Antigen Injection

subcutaneous administration of Candida albicans antigen

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role lead

Responsible Party

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Erika Lizbeth Alba Rojas

Erika Alba Rojas

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fania Muñoz Garza, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario "Dr. José E. González"

Locations

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Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Erika Alba-Rojas, MD

Role: CONTACT

+528183891111

Facility Contacts

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Erika Alba Rojas, MD

Role: primary

+528183891111

Other Identifiers

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DE24-00008

Identifier Type: -

Identifier Source: org_study_id

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