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Status unknownNCT06564805Updated Aug 21, 2024

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

An interventional study of Candida Albicans Antigen Injection in Alopecia Areata, sponsored by Universidad Autonoma de Nuevo Leon. Status unknown at 1 site in Mexico. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Universidad Autonoma de Nuevo Leon · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
6 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Alopecia Areata

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03

In context

Alopecia Areata

469 studies on the registry are indexed under Alopecia Areata; 91 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 381 interventional studies indexed under Alopecia Areata.

Browse Alopecia Areata studies →

Lead sponsor

Universidad Autonoma de Nuevo Leon is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    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

    Drug: Candida Albicans Antigen Injection

  • Experimental
    Candida albicans antigen

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

    Drug: Candida Albicans Antigen Injection

Interventions

06

What researchers measure

Primary outcomes

  1. Treatment response

    porcentage of hair growth determined by SALT score

    Time frame: 5 months

Secondary outcomes

  1. Side effects

    Side effects associated to the treatment

    Time frame: 5 months

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitario "Dr. José Eleuterio González"
    Monterrey, Nuevo León 64460, Mexico
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — The database with the main clinical and trichoscopic results could be shared

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Jul 2025, 11 months after the start.

Of 56 non-industry interventional studies with no phase under Alopecia Areata, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 24. This study's planned 11 months is close to that.

Counting every sponsor, half of 89 studies reached it within 11 months; a quarter within 6 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2024
First posted
Aug 21, 2024
StartActual
Aug 20, 2024
Primary completionEst.
Jul 30, 2025
CompletionEst.
Dec 31, 2025
Last update
Aug 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06564805
Lead sponsor
Universidad Autonoma de Nuevo Leon
Responsible party
Erika Lizbeth Alba Rojas (Erika Alba Rojas, Universidad Autonoma de Nuevo Leon) — Principal investigator
First posted
Aug 21, 2024
Start date
Aug 20, 2024
Primary completion
Jul 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 21, 2024

Study contacts

Erika Alba-Rojas, MD
Contact
eri9ar@yahoo.com
+528183891111
Fania Muñoz Garza, PhD
principal investigator · Hospital Universitario "Dr. José E. González"

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Candida albicans Antigen Injection

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