Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation

July 17, 2021 updated by: Shahira Ramadan, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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
      • Cairo, Egypt, 11956
        • Recruiting
        • Cairo University

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: NbUVB
Group A: patients will receive three NB-UVB sessions per week for 48 sessions.
Other: Narrow band ultraviolet B
Patients receive nbUVB session 3 times per week
EXPERIMENTAL: 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.
Other: Narrow band ultraviolet B
Patients receive nbUVB session 3 times per week
Drug: Acitretin
The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed
Other Names:
  • Acitretin 25Mg Cap
  • Acitretin 10Mg Cap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index
Time Frame: 4-5 months
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)
4-5 months
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score.
Time Frame: 4-5 months
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).
4-5 months

Collaborators and Investigators

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

Sponsor

Cairo 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 (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

November 30, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (ACTUAL)

January 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 17, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acitretin in vitiligo

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

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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