Intralesional Vitamin D in Alopecia Areata

July 23, 2021 updated by: marwa eldeeb, Alexandria University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt, 21521
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intralesional injection of triamcinolone acetonide
5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions
Drug: triamcinolone acetonide
local immunosuprresent
Active Comparator: intralesional injection of vitamin D
(2.5 mg/mL) every 4 weeks for 3 sessions
Drug: vitamin D
local immunomodulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regrowth Score (RGS)
Time Frame: 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%)
three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0304857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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