Intralesional Vitamin D in Alopecia Areata

NCT04660786 | Unknown Phase 1

• 1 other identifier: 0304857
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

intralesional injection of triamcinolone acetonide

ACTIVE COMPARATOR

5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions

Drug: triamcinolone acetonide

intralesional injection of vitamin D

ACTIVE COMPARATOR

(2.5 mg/mL) every 4 weeks for 3 sessions

Drug: vitamin D

Interventions

triamcinolone acetonide DRUG

local immunosuprresent

intralesional injection of triamcinolone acetonide

vitamin D DRUG

local immunomodulator

intralesional injection of vitamin D

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, 21521, Egypt

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Triamcinolone Acetonide; Vitamin D

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Secosteroids

Central Study Contacts

marwa eldeeb

CONTACT

01200029774; marwa.eldeeb16@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of dermatology

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 9, 2020
• Study Start: November 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)