- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02151630
Pyruvic Acid Versus Salicylic Acid Preparation in Treatment of Plantar Warts
May 29, 2014 updated by: Fatima Assaf, Isfahan University of Medical Sciences
Comparison of 70% Pyruvic Acid Solution and Duofilm Solution in Treatment of Plantar Wart
Plantar warts can be bothersome and painful requiring treatment.
The investigators will compare the efficacy of pyruvic acid and salicylic acid in treating multiple plantar warts.
Patients with multiple plantar warts will be randomized to receive either pyruvic acid 70% or compound salicylic acid solution (salicylic acid 16.7%, lactic acid 16.7%, and collodion 100%) applying topically twice a day for 4 weeks.
Patients will be visited every 2 weeks for one month after starting treatment and then every one month for up to 3 months.
The number and size of warts will be evaluated.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fatima Assaf, M.D.
- Phone Number: 0098 913 0965384
- Email: dr.assafsaid@gmail.com
Study Locations
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-
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Isfahan, Iran, Islamic Republic of
- Recruiting
- Skin Diseases and Leishmaniasis Research Center
-
Contact:
- Fatima Assaf, M.D.
- Phone Number: 0098 913 0965384
- Email: dr.assafsaid@gmail.com
-
Principal Investigator:
- Fatima Assaf, M.D.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 12 years and above
- multiple warts (at least 2)
Exclusion Criteria:
- mosaic warts
- already under any treatment for warts
- pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pyruvic acid
Patients will receive pyruvic acid solution 70% prepared by solving of pyruvic acid in water/ethanol solution.
Patients will be advised to apply the solution twice daily for a period of four weeks.
Application of petrolatum to the surrounding normal skin protects against the corrosive effect of the concentrated acid.
|
|
Active Comparator: Salicylic acid
Patients will receive a combination of salicylic acid 16.7%, lactic acid 16.7%, and collodion 100%.
Patients will be advised to apply the solution twice daily for a period of four weeks.
Application of petrolatum to the surrounding normal skin protects against the corrosive effect of the concentrated acid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wart number
Time Frame: From before to 3 months after
|
Patients will be visited every two weeks for one month and then every month for up to 3 months by a dermatologist.
On each visit, warts will be inspected to determine the number of warts.
Any wart totally non-detectable by inspection and touch will be considered as healed.
|
From before to 3 months after
|
Wart size
Time Frame: From before to 3 months after
|
Patients will be visited every two weeks for one month and then every month for up to 3 months by a dermatologist.
On each visit, warts will be inspected to determine the size of warts.
The size of the warts will be calculated as the mean size of all the warts.
|
From before to 3 months after
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fatima Assaf, M.D., Isfahan University of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Anticipated)
September 1, 2014
Study Completion (Anticipated)
September 1, 2014
Study Registration Dates
First Submitted
May 28, 2014
First Submitted That Met QC Criteria
May 29, 2014
First Posted (Estimate)
May 30, 2014
Study Record Updates
Last Update Posted (Estimate)
May 30, 2014
Last Update Submitted That Met QC Criteria
May 29, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- Musculoskeletal Diseases
- DNA Virus Infections
- Skin Diseases, Infectious
- Papillomavirus Infections
- Skin Diseases, Viral
- Tumor Virus Infections
- Warts
- Foot Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Salicylic Acid
- Salicylates
Other Study ID Numbers
- 393219
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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