Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation
Primary Purpose
Hyperlipidemias, Xerosis, Depression
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acitretin
Narrow band ultraviolet B
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemias
Eligibility Criteria
Inclusion Criteria:
- Patients with generalized non-segmental vitiligo (25%-75%)
- 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:
- Children ˂ 18 years old
- 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
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
NbUVB
Combined nbUVB and Acitretin
Arm Description
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.
Outcomes
Primary Outcome Measures
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Area Scoring Index (VASI)
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score.
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Disease Activity Score (VIDA).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04245319
Brief Title
Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation
Official Title
Assessment of the Combined Effect of Acitretin and Narrow Band Ultraviolet B (Nb-UVB) on the Clinical Repigmentation and on the Expression of E-cadherins in Vitiligo Lesions in Comparison to Narrow Band UVB Alone. A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Since abnormal keratinocyte (KC) proliferation and differentiation as well as defective E cadherin expression were reported in vitiligo lesions, the investigators set to study the potential efficacy of combining Retinoids, which are known to improve KC proliferation and differentiation and increase the expression of adhesion molecules, with narrowband UVB in the treatment of vitiligo.
Detailed Description
• Twenty patients with generalized vitiligo will be included in this study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias, Xerosis, Depression, Liver Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 0.3 mg/kg/day daily.
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NbUVB
Arm Type
Other
Arm Description
Group A: patients will receive three NB-UVB sessions per week for 48 sessions.
Arm Title
Combined nbUVB and Acitretin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acitretin
Other Intervention Name(s)
Acitretin 25Mg Cap, Acitretin 10Mg Cap
Intervention Description
The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed
Intervention Type
Other
Intervention Name(s)
Narrow band ultraviolet B
Intervention Description
Patients receive nbUVB session 3 times per week
Primary Outcome Measure Information:
Title
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index
Description
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Area Scoring Index (VASI)
Time Frame
4-5 months
Title
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score.
Description
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Disease Activity Score (VIDA).
Time Frame
4-5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with generalized non-segmental vitiligo (25%-75%)
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:
Children ˂ 18 years old
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noha A. Saleh, M.Sc
Phone
+201222177210
Email
noushy2938@gmail.com
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11956
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation
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