Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation

August 7, 2023 updated by: Shaimaa Fawzy Abdel-rady Abdel-latif
The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

the study is to evaluate the efficacy of NB-UVB, latanoprost, and combination of them on the TWEAK serum level in patients with non-segmental vitiligo.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Aswan Governorate
      • Aswan, Aswan Governorate, Egypt, 81528
        • faculty of medicine, Aswan 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with non-segmental vitiligo of any age and gender.

Exclusion Criteria:

  • History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks.
  • Pregnancy and lactation.
  • Infections
  • Patients with other autoimmune diseases.
  • Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NB-UVB radiation
will expose to 2 sessions/week of NB-UVB radiation, for 3 months.
Radiation: NB-UVB
radiation
Other Names:
  • narrow band ultraviolet B
Active Comparator: Latanoprost
latanoprost 0.005%, will be applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches. The procedure will be repeated once weekly for 3 months (12 sessions).
Drug: Latanoprost
eye drops
Other Names:
  • latanoprost eye drops
Active Comparator: latanoprost + NB-UVB
(latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2.
Radiation: NB-UVB
radiation
Other Names:
  • narrow band ultraviolet B
Drug: Latanoprost
eye drops
Other Names:
  • latanoprost eye drops
No Intervention: healthy individuals
healthy individuals as control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum TWEAK in vitiligo
Time Frame: 3months
measurement of serum Tumor necrosis factor weak inducer of apoptosis (TWEAK)"pg/ml"; in vitiligo patients before and after treatment with NB-UVB, Latanoprost and their combination, all in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay)
3months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment of vitiligo
Time Frame: 3 months
clinical evaluation: Assessment of the disease severity in non-segmental vitiligo will be performed by using vitiligo area severity index (VASI score) before and after treatment with NB-UVB, latanoprost application applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches, or combination of both of them. Patients will be photographed at baseline and after 3 months of regular treatment by using high resolution digital camera conon EOS 1300D 18 megapixels (made in Taiwan), photography will be done in standard light and distance.
3 months

Collaborators and Investigators

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

Sponsor

Shaimaa Fawzy Abdel-rady Abdel-latif

Investigators

  • Study Chair: Moustafa A El Taieb, prof., Prof. and Head of Dermatology, Venereology and Andrology department, Aswan University, Egypt

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 13, 2021

Primary Completion (Estimated)

February 13, 2024

Study Completion (Estimated)

March 13, 2024

Study Registration Dates

First Submitted

March 7, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 504/1/21

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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