Treatment of Plantar Warts
Primary Purpose
Plantar Wart
Status
Not yet recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Topical 30%Potassium hydroxide solution
Topical 45% hydrogen peroxide solution
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Wart
Eligibility Criteria
Inclusion Criteria:
- confirmed diagnosis by clinical and dermoscopic examination of plantar warts
Exclusion Criteria:
- history of hypersensitivity to any component used in this study
- pregnancy and breastfeeding
- patients who receive immune suppressive therapy
- patients who received any wart treatments during the last 2 months before enrollent in the study
- patients who refused participation in the study
Sites / Locations
- Sohag faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Potassium hydroxide group
Hydrogen peroxide group
Arm Description
Patients with plantar warts will apply topical 30% potassium hydroxide solutions on warts
Patients with plantar warts will use topical 45% hydrogen peroxide solution on warts
Outcomes
Primary Outcome Measures
Change in the size of the plantar warts
Decrease in the size of warts measured by a ruler
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05198180
Brief Title
Treatment of Plantar Warts
Official Title
Comparative Study Between Topical30%Potassium Hydroxide Solution and Topical 45% Hydrogen Peroxide Solution in Treatment of Plantar Warts
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag 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
This study is to compare the efficacy and safety of topical 30% potassium hydroxide solution and topical 45% hydrogen peroxide solution in treatment of plantar warts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Wart
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Potassium hydroxide group
Arm Type
Active Comparator
Arm Description
Patients with plantar warts will apply topical 30% potassium hydroxide solutions on warts
Arm Title
Hydrogen peroxide group
Arm Type
Active Comparator
Arm Description
Patients with plantar warts will use topical 45% hydrogen peroxide solution on warts
Intervention Type
Drug
Intervention Name(s)
Topical 30%Potassium hydroxide solution
Intervention Description
Patients will apply the solution every day under occlusion for 3 months
Intervention Type
Drug
Intervention Name(s)
Topical 45% hydrogen peroxide solution
Intervention Description
Patients will apply the solution every day under occlusion
Primary Outcome Measure Information:
Title
Change in the size of the plantar warts
Description
Decrease in the size of warts measured by a ruler
Time Frame
12 weeks after end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed diagnosis by clinical and dermoscopic examination of plantar warts
Exclusion Criteria:
history of hypersensitivity to any component used in this study
pregnancy and breastfeeding
patients who receive immune suppressive therapy
patients who received any wart treatments during the last 2 months before enrollent in the study
patients who refused participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar Sa Ahmed, Resident
Phone
01152471005
Email
Summersayed156@gmail.com
Facility Information:
Facility Name
Sohag faculty of medicine
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samar Sa Ahmed, Resident
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Plantar Warts
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