Plantar WartPhase 3NCT05198180
Treatment of Plantar Warts
A Phase 3 study testing Topical 30%Potassium hydroxide solution and Topical 45% hydrogen peroxide solution in people with Plantar Wart, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Plantar Wart
- What is being tested?
- Topical 30%Potassium hydroxide solution and Topical 45% hydrogen peroxide solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2022to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- confirmed diagnosis by clinical and dermoscopic examination of plantar warts
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Topical30%Potassium Hydroxide Solution and Topical 45% Hydrogen Peroxide Solution in Treatment of Plantar Warts
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.
- Conditions
- Plantar Wart
- Being tested
- Topical 30%Potassium hydroxide solution, Topical 45% hydrogen peroxide solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical 30%Potassium hydroxide solutionDrug
Patients will apply the solution every day under occlusion for 3 months
Topical 45% hydrogen peroxide solutionDrug
Patients will apply the solution every day under occlusion
| Study group | Role | What they receive |
|---|---|---|
| Potassium hydroxide group | Active comparator | Patients with plantar warts will apply topical 30% potassium hydroxide solutions on warts Receives: Drug: Topical 30%Potassium hydroxide solution |
| Hydrogen peroxide group | Active comparator | Patients with plantar warts will use topical 45% hydrogen peroxide solution on warts Receives: Drug: Topical 45% hydrogen peroxide solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the size of the plantar warts
Decrease in the size of warts measured by a ruler
Measured: 12 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study startFeb 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar WartStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Sayed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198180
- Sponsor's protocol ID
- Sohag-Mes-21-11-07
- Status last verified
- Jan 2022
- First submitted
- 26 Dec 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Topical30%Potassium Hydroxide Solution and Topical 45% Hydrogen Peroxide Solution in Treatment of Plantar Warts
- ClinicalTrials.gov ID
- NCT05198180
- Acronym / sponsor ID
- Sohag-Mes-21-11-07
- Conditions
- Plantar Wart
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium hydroxide group | Active comparator | Drug: Topical 30%Potassium hydroxide solutionPatients with plantar warts will apply topical 30% potassium hydroxide solutions on warts |
| Hydrogen peroxide group | Active comparator | Drug: Topical 45% hydrogen peroxide solutionPatients with plantar warts will use topical 45% hydrogen peroxide solution on warts |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- confirmed diagnosis by clinical and dermoscopic examination of plantar warts
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical 30%Potassium hydroxide solutionPatients will apply the solution every day under occlusion for 3 months | Drug | Potassium hydroxide group |
| Topical 45% hydrogen peroxide solutionPatients will apply the solution every day under occlusion | Drug | Hydrogen peroxide group |
Primary outcome
Change in the size of the plantar warts
Time frame: 12 weeks after end of treatment
Decrease in the size of warts measured by a ruler
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical 30%Potassium hydroxide solution and Topical 45% hydrogen peroxide solution in people with Plantar Wart, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar Sa Ahmed, Resident (01152471005, Summersayed156@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the size of the plantar warts (time frame: 12 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.