Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study

April 13, 2024 updated by: Sara Hassan Ahmed, Sohag University
For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Each patient will sign a written consent form to be included in the study and to be photographed.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Egypt
      • Sohag, Egypt, 82515
        • Faculty of Medicine, Sohag 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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients with stable non segmental vitiligo. (Absence of koebnerization, absence of new lesion and absence of widening of the existing lesions).

Patients have more than 15 years.

-

Exclusion Criteria:

Patients have active vitiligo (appearance of new lesion, history of koebnerization).

Pregnant and lactating women. History of keloid formation. Anemia (hemoglobin level <10gm/dl), thrombocytopenia (platelet count <100,000 /µL), coagulopathies or patients on anticoagulant therapy and patients with iron deficiency.

Patients taking drugs that prolong bleeding time such as Aspirin and vitamin E Patients taking treatment of vitiligo in last 2 months

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Narrow band UVB
Procedure: platelet rich plasma, narrow band UVB
Role of PRP in treating stable vitiligo
Active Comparator: Platelet rich plasma plus narrow band UVB
Procedure: platelet rich plasma, narrow band UVB
Role of PRP in treating stable vitiligo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of vitiligo
Time Frame: within 6 months
increase repigmentation score
within 6 months

Collaborators and Investigators

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

Sponsor

Sohag 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)

December 8, 2023

Primary Completion (Actual)

January 25, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

April 13, 2024

First Submitted That Met QC Criteria

April 13, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-med-24-1-9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Researcher shall pubish in national journal

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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