Photodynamic Therapy in Treatment of Verrucae

NCT ID: NCT04620785

Last Updated: 2021-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Verruca Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

methylene blue / IPL

Intervention Type OTHER

therapeutic

IPL

will undergo biweekly IPL sessions only until complete clearance of the lesion or a maximum four sessions.

Group Type EXPERIMENTAL

IPL

Intervention Type OTHER

therapeutic

saline

will undergo intralesional saline.

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

placebo

Interventions

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methylene blue / IPL

therapeutic

Intervention Type OTHER

IPL

therapeutic

Intervention Type OTHER

saline

placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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marwa eldeeb

lecturer of dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alexandria University Faculty of Medicine

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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amira abulfotooh eid, MD

Role: primary

01006897449

Other Identifiers

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0106171

Identifier Type: -

Identifier Source: org_study_id

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