Intralesional Vitamin D in Alopecia Areata

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04660786

Enrollment

Registered

2020-12-09

Start date

2021-11-01

Completion date

2022-12-01

Last updated

2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

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.

Interventions

DRUGtriamcinolone acetonide

local immunosuprresent

DRUGvitamin D

local immunomodulator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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%)

Countries

Egypt

Contacts

Primary Contactmarwa eldeeb

marwa.eldeeb16@alexmed.edu.eg01200029774

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026