Intralesional Vitamin D in Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04660786
• Other study ID #: 0304857
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2021
• Source: Alexandria University
• Contact: marwa eldeeb
• Phone: 01200029774
• Email: marwa.eldeeb16[@]alexmed.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• triamcinolone acetonide
local immunosuprresent
• vitamin D
local immunomodulator

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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