Study Results
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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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2021-11-01
2022-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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intralesional injection of triamcinolone acetonide
5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions
triamcinolone acetonide
local immunosuprresent
intralesional injection of vitamin D
(2.5 mg/mL) every 4 weeks for 3 sessions
vitamin D
local immunomodulator
Interventions
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triamcinolone acetonide
local immunosuprresent
vitamin D
local immunomodulator
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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).
10 Years
ALL
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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marwa eldeeb
lecturer of dermatology
Locations
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Faculty of Medicine
Alexandria, , Egypt
Countries
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Central Contacts
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Other Identifiers
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0304857
Identifier Type: -
Identifier Source: org_study_id
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