Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation
NCT ID: NCT04245319
Last Updated: 2021-07-22
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
NA
20 participants
INTERVENTIONAL
2020-01-01
2021-12-01
Brief Summary
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Detailed Description
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All patients will be subjected to:
* Clinical evaluation:
* An informed written consent.
* History taking include age, previous treatment, disease activity
* Clinical examination including Vitiligo Area Scoring Index (VASI) and Vitiligo Disease Activity Score (VIDA)
* Photography (before starting the treatment and every 2 weeks till the end of the study)
Laboratory evaluation:
* 2 mm punch skin biopsies will be taken from vitiligo patients, 1 from lesional and the other from perilesional skin before treatment.
* The patients will be randomly assigned to two groups:
Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily.
* Controls: 20 individuals age and sex matched will be biopsied from the skin of their abdominoplasty surgery.
* Another two 2 mm punch skin biopsies will be taken from lesional and perilesional skin at the onset of repigmentation if repigmentation starts before completion of the 48 treatment session or after completion of the treatment period if repigmentation does not occur.
* .All biopsies from patients and controls will be stained Immunohistochemically by anti-E cadherin antibody.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NbUVB
Group A: patients will receive three NB-UVB sessions per week for 48 sessions.
Narrow band ultraviolet B
Patients receive nbUVB session 3 times per week
Combined nbUVB and Acitretin
Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily.
Acitretin
The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed
Narrow band ultraviolet B
Patients receive nbUVB session 3 times per week
Interventions
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Acitretin
The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed
Narrow band ultraviolet B
Patients receive nbUVB session 3 times per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males, postmenopausal females and premenopausal females not planning to get pregnant during the period of treatment and after 2 years from the end of treatment.
* Age more than 18 years.
Exclusion Criteria
* Pregnant females
* Premenopausal females planning to get pregnant within the period of treatment or within 2 years after.
* Patients receiving treatment for vitiligo within the past 2 months.
* Patients with abnormal liver profile
* Patients with abnormal lipid profile
* Patients with associated photosensitive disorders
* Patients having associated skin diseases other than vitiligo
* Cataract and aphakia
* High cumulative dose from previous sessions of narrowband ˃ 200-300 session
18 Years
60 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Shahira Ramadan
Professor
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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Acitretin in vitiligo
Identifier Type: -
Identifier Source: org_study_id
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