Alopecia AreataNCT06564805
Clinical Trial on the Efficacy of Intralesional Triamcinolone Versus Candida Albicans Antigen in Treating Alopecia Areata
A study testing Candida Albicans Antigen Injection in people with Alopecia Areata, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Candida Albicans Antigen Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 20 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460
Erika Alba Rojas, MD, +528183891111, eri9ar@yahoo.com
About this study
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
- Being tested
- Candida Albicans Antigen Injection
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candida Albicans Antigen InjectionDrug
subcutaneous administration of Candida albicans antigen
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Candida Albicans Antigen Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
porcentage of hair growth determined by SALT score
Measured: 5 months
Secondary outcomes (1)
Side effects
Side effects associated to the treatment
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start20 Aug 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Lizbeth Alba Rojas, Universidad Autonoma de Nuevo Leon
- Investigators
- Fania Muñoz Garza, PhD, Principal investigator, Hospital Universitario "Dr. José E. González"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564805
- Sponsor's protocol ID
- DE24-00008
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The database with the main clinical and trichoscopic results could be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Efficacy of Intralesional Triamcinolone Versus Candida Albicans Antigen in Treating Alopecia Areata
- ClinicalTrials.gov ID
- NCT06564805
- Acronym / sponsor ID
- DE24-00008
- Conditions
- Alopecia Areata
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intralesional Triamcinolone | Active comparator | Drug: Candida Albicans Antigen InjectionTriamcinolone 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 | Experimental | Drug: Candida Albicans Antigen InjectionSingle subcutaneous administration of 0.1 mL of Candida albicans antigen into one of the alopecic patches |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candida Albicans Antigen Injectionsubcutaneous administration of Candida albicans antigen | Drug | Candida albicans antigen, intralesional Triamcinolone |
Primary outcome
Treatment response
Time frame: 5 months
porcentage of hair growth determined by SALT score
1 secondary outcome
Side effects
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: Undecided. The database with the main clinical and trichoscopic results could be shared
Related trials for Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fania Muñoz Garza, PhD principal investigator
Hospital Universitario "Dr. José E. González"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Candida Albicans Antigen Injection in people with Alopecia Areata, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erika Alba-Rojas, MD (+528183891111, eri9ar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.