NCT05198180

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

December 26, 2021

Last Update Submit

January 15, 2022

Conditions

Plantar Wart

Outcome Measures

Primary Outcomes (1)

  • Change in the size of the plantar warts

    Decrease in the size of warts measured by a ruler

    12 weeks after end of treatment

Study Arms (2)

Potassium hydroxide group

ACTIVE COMPARATOR

Patients with plantar warts will apply topical 30% potassium hydroxide solutions on warts

Drug: Topical 30%Potassium hydroxide solution

Hydrogen peroxide group

ACTIVE COMPARATOR

Patients with plantar warts will use topical 45% hydrogen peroxide solution on warts

Drug: Topical 45% hydrogen peroxide solution

Interventions

Topical 30%Potassium hydroxide solutionDRUG

Patients will apply the solution every day under occlusion for 3 months

Potassium hydroxide group
Topical 45% hydrogen peroxide solutionDRUG

Patients will apply the solution every day under occlusion

Hydrogen peroxide group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed diagnosis by clinical and dermoscopic examination of plantar warts

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty of medicine

Sohag, Egypt

Location

Central Study Contacts

Samar Sa Ahmed, Resident

CONTACT

01152471005Summersayed156@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 26, 2021

First Posted

January 20, 2022

Study Start

February 1, 2022

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)