Intralesional Vitamin D in Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
triamcinolone acetonide
vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata
Eligibility Criteria
Inclusion Criteria:
Site: scalp. Extent: localized alopecia areata (less than 50% scalp involvement).
Exclusion Criteria:
- 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).
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
intralesional injection of triamcinolone acetonide
intralesional injection of vitamin D
Arm Description
5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions
(2.5 mg/mL) every 4 weeks for 3 sessions
Outcomes
Primary Outcome Measures
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%)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04660786
Brief Title
Intralesional Vitamin D in Alopecia Areata
Official Title
Intralesional Vitamin D3 Injection in Treatment of Alopecia Areata: A Novel Approach
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intralesional injection of triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions
Arm Title
intralesional injection of vitamin D
Arm Type
Active Comparator
Arm Description
(2.5 mg/mL) every 4 weeks for 3 sessions
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Intervention Description
local immunosuprresent
Intervention Type
Drug
Intervention Name(s)
vitamin D
Intervention Description
local immunomodulator
Primary Outcome Measure Information:
Title
Regrowth Score (RGS)
Description
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%)
Time Frame
three month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Site: scalp. Extent: localized alopecia areata (less than 50% scalp involvement).
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marwa eldeeb
Phone
01200029774
Email
marwa.eldeeb16@alexmed.edu.eg
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21521
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Intralesional Vitamin D in Alopecia Areata
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