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

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

Study Locations

      • Isfahan, Iran, Islamic Republic of
        • Recruiting
        • Skin Diseases and Leishmaniasis Research Center
        • Contact:
        • Principal Investigator:
          • Fatima Assaf, M.D.

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

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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