Photodynamic Therapy in Treatment of Verrucae

July 23, 2021 updated by: marwa eldeeb, Alexandria University

PHOTODYNAMIC THERAPY USING METHYLENE BLUE AND INTENSE PULSED LIGHT VERSUS INTENSE PULSED LIGHT ALONE IN TREATMENT OF VERRUCA :A RANDOMIZED CONTROLLED STUDY

To assess the efficacy (clinically and dermoscopically) and safety of photodynamic therapy using intralesional injection of 4% methylene blue solution as a photosensitizer with IPL versus IPL only in treatment of warts.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted on:

Eighty patients suffering of verruca (male and female) divided randomly into three groups: group A, B&C :

Group A: 30 patients will undergo photodynamic therapy using intralesional 4%methylene blue solution and IPL.

Group B: 30 patients will undergo IPL only. Group C (control group):20 patients will undergo intralesional saline.

Study Type

Interventional

Enrollment (Anticipated)

80

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
      • Alexandria, Egypt
        • Recruiting
        • Alexandria University Faculty of Medicine
        • Contact:

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age:Above 16 years old.
  2. Sex:Both males and female patients.
  3. Clinically and dermoscopically documented verruca.
  4. No verruca treatment in the last 2 weeks.

Exclusion Criteria:

  1. History of photosensitivity disorder.
  2. Pregnant and lactating females.
  3. Diseases with risk of koebnerization e.g. Psoriasis and Lichen planus.
  4. Anogenital warts.
  5. Warts on head and neck.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: methylene blue/IPL

will undergo photodynamic therapy using intralesional 4%methylene blue solution ,after a period of 15 minutes the patient will be subjected to IPL session.

This will be repeated biweekly until complete clearance of the lesion or a maximum four sessions.
Other: methylene blue / IPL
therapeutic
Experimental: IPL
will undergo biweekly IPL sessions only until complete clearance of the lesion or a maximum four sessions.
Other: IPL
therapeutic
Placebo Comparator: saline
will undergo intralesional saline.
Other: saline
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disappearance of verruca
Time Frame: 10 weeks
clinical and dermoscopic cure
10 weeks

Collaborators and Investigators

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

Sponsor

Alexandria 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)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0106171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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