Intralesional Vitamin D in Alopecia Areata

NCT ID: NCT04660786

Last Updated: 2021-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-01

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.

Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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intralesional injection of triamcinolone acetonide

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

Group Type ACTIVE_COMPARATOR

triamcinolone acetonide

Intervention Type DRUG

local immunosuprresent

intralesional injection of vitamin D

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

Group Type ACTIVE_COMPARATOR

vitamin D

Intervention Type DRUG

local immunomodulator

Interventions

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triamcinolone acetonide

local immunosuprresent

Intervention Type DRUG

vitamin D

local immunomodulator

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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marwa eldeeb

lecturer of dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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marwa eldeeb

Role: CONTACT

01200029774

Other Identifiers

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0304857

Identifier Type: -

Identifier Source: org_study_id

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