- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07803874
UV-Trichoscopic Red Fluorescence in Alopecia Areata
Evaluation of UV-Trichoscopic Red Fluorescence Intensity in Relation to Trichoscopic Findings and Response to Intralesional Corticosteroid Treatment in Limited Plaque-Type Alopecia Areata
Study Overview
Detailed Description
This is a prospective observational cohort study involving adults with limited plaque-type alopecia areata who are receiving intralesional corticosteroid treatment as part of routine clinical care. Participation in the study does not determine whether a patient receives intralesional corticosteroid treatment.
At baseline, the affected scalp area will be evaluated using conventional polarized trichoscopy and UV-trichoscopy. Follow-up assessments will be performed at weeks 4, 8, and 12 using the same imaging approach. Trichoscopic findings of interest will include yellow dots, black dots, exclamation mark hairs, and broken hairs.
UV-trichoscopic red fluorescence will be assessed quantitatively by measuring red-channel intensity on standardized digital images. Imaging and image analysis procedures will be performed using a standardized acquisition protocol to improve comparability between visits.
Treatment response will be evaluated according to the appearance and extent of visible hair regrowth and the change in trichoscopic activity findings during follow-up. The main analysis will examine whether baseline red fluorescence intensity is associated with the timing and magnitude of response to intralesional corticosteroid treatment. Associations between red fluorescence intensity and baseline trichoscopic findings, as well as changes in fluorescence intensity and trichoscopic findings over time, will also be evaluated.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sevgi Nazli Apucu, Dermatology Resident Physician
- Phone Number: +905374048180
- Email: snapucu@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul Training and Research Hospital
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Contact:
- Sevgi Nazli Apucu, Dermatology Resident Physician
- Phone Number: +905374048180
- Email: snapucu@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- Limited plaque-type alopecia areata of the scalp
- Active hair loss
- Symptom onset within the previous 6 months
- No topical, intramuscular, or oral treatment for alopecia areata within the previous 1 month
- No intralesional corticosteroid treatment within the previous 6 weeks
- Provision of informed consent
Exclusion Criteria:
- Beard alopecia areata
- Very extensive alopecia areata or multiple large plaques
- Tinea capitis or active infection
- Current phototherapy
- Systemic immunosuppressive treatment within the washout period specified in the study protocol
- Pregnancy or breastfeeding
- Contraindication to UV imaging
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Limited Plaque-Type Alopecia Areata
Adults with limited plaque-type alopecia areata who are receiving intralesional corticosteroid treatment as part of routine clinical care.
Participants will undergo conventional trichoscopic and UV-trichoscopic assessments at baseline and during follow-up at weeks 4, 8, and 12. Hair regrowth, trichoscopic findings, and UV-trichoscopic red fluorescence intensity will be evaluated over time.
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Intralesional triamcinolone acetonide is administered for limited plaque-type alopecia areata as part of routine clinical care.
The decision to administer treatment is made independently of participation in this observational study.
The study prospectively evaluates trichoscopic and UV-trichoscopic findings and hair regrowth during routine treatment follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Association Between Baseline UV-Trichoscopic Red Fluorescence Intensity and Timing of First Visible Hair Regrowth
Time Frame: Baseline through week 12
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Baseline UV-trichoscopic red fluorescence intensity will be quantified from standardized digital images using red-channel intensity measurements.
Participants will be evaluated for the first appearance of visible hair regrowth at follow-up visits at weeks 4, 8, and 12.
The association between baseline red fluorescence intensity and the timing of first visible hair regrowth will be assessed.
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Baseline through week 12
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Association Between Baseline UV-Trichoscopic Red Fluorescence Intensity and Degree of Hair Regrowth
Time Frame: Weeks 4, 8, and 12
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The degree of hair regrowth will be assessed at follow-up visits using standardized clinical photographs and trichoscopic images of the alopecic plaque.
Hair regrowth will be evaluated according to the proportion of the baseline alopecic area showing visible regrowth, with trichoscopic examination used to identify early or fine regrowing hairs that may not be clearly visible in clinical photographs.
The association between baseline UV-trichoscopic red fluorescence intensity and the degree of hair regrowth will be evaluated.
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Weeks 4, 8, and 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in UV-Trichoscopic Red Fluorescence Intensity During Follow-up
Time Frame: Baseline and weeks 4, 8, and 12
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UV-trichoscopic red fluorescence intensity will be quantified from standardized digital images using red-channel intensity measurements.
Changes in red fluorescence intensity from baseline through follow-up visits will be evaluated
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Baseline and weeks 4, 8, and 12
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Change in Trichoscopic Activity Findings During Follow-up
Time Frame: Baseline and weeks 4, 8, and 12
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Trichoscopic activity findings, including yellow dots, black dots, exclamation mark hairs, and broken hairs, will be recorded using standardized trichoscopic images.
Changes in these findings during follow-up will be evaluated.
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Baseline and weeks 4, 8, and 12
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Association Between Baseline UV-Trichoscopic Red Fluorescence Intensity and Trichoscopic Findings
Time Frame: Baseline
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The association between baseline UV-trichoscopic red fluorescence intensity and baseline trichoscopic findings, including yellow dots, black dots, exclamation mark hairs, and broken hairs, will be evaluated.
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Baseline
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Collaborators and Investigators
Investigators
- Study Chair: Vildan Manav, Istanbul Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulTRH-DERM-AAUV-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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