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Clinical Trials/NCT06564805
NCT06564805RecruitingNot Applicable

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

Universidad Autonoma de Nuevo Leon1 site in 1 country30 target enrollmentStarted: August 20, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Treatment response

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: Candida Albicans Antigen Injection (Drug)

Candida albicans antigen

Experimental

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

Intervention: Candida Albicans Antigen Injection (Drug)

Outcomes

Primary Outcomes

Treatment response

Time Frame: 5 months

porcentage of hair growth determined by SALT score

Secondary Outcomes

  • Side effects(5 months)

Investigators

Sponsor
Universidad Autonoma de Nuevo Leon
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Erika Lizbeth Alba Rojas

Erika Alba Rojas

Universidad Autonoma de Nuevo Leon

Study Sites (1)

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