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Pyruvic Acid Versus Salicylic Acid Preparation in Treatment of Plantar Warts

Primary Purpose

Plantar Wart

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pyruvic acid
Salicylic Acid
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Wart focused on measuring wart, verruca vulgaris, topical therapy, pyruvic acid, salicylic acid

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Skin Diseases and Leishmaniasis Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pyruvic acid

Salicylic acid

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Wart number
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.
Wart size
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.

Secondary Outcome Measures

Full Information

First Posted
May 28, 2014
Last Updated
May 29, 2014
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02151630
Brief Title
Pyruvic Acid Versus Salicylic Acid Preparation in Treatment of Plantar Warts
Official Title
Comparison of 70% Pyruvic Acid Solution and Duofilm Solution in Treatment of Plantar Wart
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Wart
Keywords
wart, verruca vulgaris, topical therapy, pyruvic acid, salicylic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pyruvic acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Salicylic acid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pyruvic acid
Intervention Type
Drug
Intervention Name(s)
Salicylic Acid
Primary Outcome Measure Information:
Title
Wart number
Description
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.
Time Frame
From before to 3 months after
Title
Wart size
Description
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.
Time Frame
From before to 3 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima Assaf, M.D.
Phone
0098 913 0965384
Email
dr.assafsaid@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Assaf, M.D.
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skin Diseases and Leishmaniasis Research Center
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatima Assaf, M.D.
Phone
0098 913 0965384
Email
dr.assafsaid@gmail.com
First Name & Middle Initial & Last Name & Degree
Fatima Assaf, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
21219294
Citation
Kwok CS, Holland R, Gibbs S. Efficacy of topical treatments for cutaneous warts: a meta-analysis and pooled analysis of randomized controlled trials. Br J Dermatol. 2011 Aug;165(2):233-46. doi: 10.1111/j.1365-2133.2011.10218.x. Epub 2011 May 26.
Results Reference
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Pyruvic Acid Versus Salicylic Acid Preparation in Treatment of Plantar Warts

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