Intralesional Vitamin D in Alopecia Areata

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of intralesional injection of vitamin D3 versus intralesional injection of corticosteroids in treatment of alopecia areata. this will be carried out on 40 patients who attend hair outpatient clinic, department of dermatology, Faculty of medicine, Alexandria University, Egypt. The patients will be randomly assigned into two groups (A and B), each group contains 20 patients. Patients will be blindly subjected to intralesional injection of triamcinolone acetonide (5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions (11,12) or intralesional injection of vitamin D (an aqueous preparation of cholecalciferol (Devarol® ampoule 200,000 IU/2 mL, Memphis, Egypt) (2.5 mg/mL) every 4 weeks for 3 sessions. The maximum total amount of vitamin D3 injected into a patient in 1 session will be 5 mg Injection will be preceded by topical anaesthesia under occlusion for 30 minutes.

Official Title
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Intralesional Vitamin D3 Injection in Treatment of Alopecia Areata: A Novel Approach

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: triamcinolone acetonide
* Drug: vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Site: scalp. Extent: localized alopecia areata (less than 50% scalp involvement). Exclusion Criteria: Other skin diseases affecting the scalp Pregnant or lactating women. Bleeding or coagulation disorders Immunocompromised patients. Known hypersensitivity to vitamin D3. Patients who received systemic or topical treatment for alopecia areata in the last month. Patients taking vitamin D supplements in the last 6 months. Patients treated with topical vitamin D analogues. Patients with diseases known to alter vitamin D level as autoimmune diseases, liver or renal diseases. Obesity (defined as body mass index ≥ 25).

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intralesional injection of triamcinolone acetonide<br>5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions | Drug: triamcinolone acetonide<br>* local immunosuprresent<br>|
| Active Comparator: intralesional injection of vitamin D<br>(2.5 mg/mL) every 4 weeks for 3 sessions | Drug: vitamin D<br>* local immunomodulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regrowth Score (RGS) | calculation at week 12 using a 5-point semiquantitative score (RGS)(0 = regrowth < 10%; 1 = regrowth 11- 25%; 2 = regrowth26 - 50%; 3 = regrowth 51- 75%; 4: regrowth > 75%) | three month |