Intralesional Vitamin D in Alopecia Areata

Phase 1

• Conditions: Alopecia Areata
• Interventions: Drug: triamcinolone acetonide; Drug: vitamin D

• Registration Number: NCT04660786
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-09
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-26
• Study Start: 2021-11-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Site: scalp. Extent: localized alopecia areata (less than 50% scalp involvement).

Exclusion Criteria

1. Other skin diseases affecting the scalp
2. Pregnant or lactating women.
3. Bleeding or coagulation disorders
4. Immunocompromised patients.
5. Known hypersensitivity to vitamin D3.
6. Patients who received systemic or topical treatment for alopecia areata in the last month.
7. Patients taking vitamin D supplements in the last 6 months.
8. Patients treated with topical vitamin D analogues.
9. Patients with diseases known to alter vitamin D level as autoimmune diseases, liver or renal diseases.
10. Obesity (defined as body mass index ≥ 25).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intralesional injection of triamcinolone acetonide	triamcinolone acetonide	5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions
intralesional injection of vitamin D	vitamin D	(2.5 mg/mL) every 4 weeks for 3 sessions

Primary Outcome Measures

Name	Time	Method
Regrowth Score (RGS)	three month	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%)

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt