Back to resultsPhotodynamic Therapy in Treatment of Verrucae
Primary Purpose
Verruca Vulgaris
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
methylene blue / IPL
IPL
saline
Sponsored by
About this trial
This is an interventional treatment trial for Verruca Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Age:Above 16 years old.
- Sex:Both males and female patients.
- Clinically and dermoscopically documented verruca.
- No verruca treatment in the last 2 weeks.
Exclusion Criteria:
- History of photosensitivity disorder.
- Pregnant and lactating females.
- Diseases with risk of koebnerization e.g. Psoriasis and Lichen planus.
- Anogenital warts.
- Warts on head and neck.
Sites / Locations
- Alexandria University Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
methylene blue/IPL
IPL
saline
Arm Description
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.
will undergo biweekly IPL sessions only until complete clearance of the lesion or a maximum four sessions.
will undergo intralesional saline.
Outcomes
Primary Outcome Measures
disappearance of verruca
clinical and dermoscopic cure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04620785
Brief Title
Photodynamic Therapy in Treatment of Verrucae
Official Title
PHOTODYNAMIC THERAPY USING METHYLENE BLUE AND INTENSE PULSED LIGHT VERSUS INTENSE PULSED LIGHT ALONE IN TREATMENT OF VERRUCA :A RANDOMIZED CONTROLLED STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Verruca Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
methylene blue/IPL
Arm Type
Experimental
Arm Description
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.
Arm Title
IPL
Arm Type
Experimental
Arm Description
will undergo biweekly IPL sessions only until complete clearance of the lesion or a maximum four sessions.
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
will undergo intralesional saline.
Intervention Type
Other
Intervention Name(s)
methylene blue / IPL
Intervention Description
therapeutic
Intervention Type
Other
Intervention Name(s)
IPL
Intervention Description
therapeutic
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
placebo
Primary Outcome Measure Information:
Title
disappearance of verruca
Description
clinical and dermoscopic cure
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age:Above 16 years old.
Sex:Both males and female patients.
Clinically and dermoscopically documented verruca.
No verruca treatment in the last 2 weeks.
Exclusion Criteria:
History of photosensitivity disorder.
Pregnant and lactating females.
Diseases with risk of koebnerization e.g. Psoriasis and Lichen planus.
Anogenital warts.
Warts on head and neck.
Facility Information:
Facility Name
Alexandria University Faculty of Medicine
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amira abulfotooh eid, MD
Phone
01006897449
Email
dramiraeid@yahoo.co.uk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Photodynamic Therapy in Treatment of Verrucae
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