Back to results17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts
Primary Purpose
Warts
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
17% Salicylate with ethyl pyruvate
Salicylates
Sponsored by
About this trial
This is an interventional treatment trial for Warts focused on measuring Warts, salicylic acid, ethyl pyruvate
Eligibility Criteria
Inclusion Criteria:
- evidence of skin plantar wart(s)
Exclusion Criteria:
- iodine allergy
Sites / Locations
- Main Line Foot and Ankle CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
17% Salicylate with Ethyl Pyruvate
17% salicylate
Arm Description
Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks.
subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks
Outcomes
Primary Outcome Measures
To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.
Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.
Secondary Outcome Measures
To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone.
Full Information
NCT ID
NCT01712295
First Posted
October 19, 2012
Last Updated
October 22, 2012
Sponsor
Grossman, Michael, D.P.M.
Collaborators
Main Line Health
1. Study Identification
Unique Protocol Identification Number
NCT01712295
Brief Title
17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts
Official Title
New Formulation of Salicylate to Improve Treatment of Common Skin Warts
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grossman, Michael, D.P.M.
Collaborators
Main Line Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. Some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as Compound W)or by other treatments that may be painful and affect mobility. No treatment is consistently effective and most patients fail treatment multiple times.
Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that may improve the activity of salicylate in wart treatment by improving the ability to penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may improve cures of common foot plantar warts in subjects who also be receiving other standard-of-care treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts
Keywords
Warts, salicylic acid, ethyl pyruvate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
17% Salicylate with Ethyl Pyruvate
Arm Type
Experimental
Arm Description
Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks.
Arm Title
17% salicylate
Arm Type
Active Comparator
Arm Description
subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks
Intervention Type
Drug
Intervention Name(s)
17% Salicylate with ethyl pyruvate
Other Intervention Name(s)
Compound W
Intervention Type
Drug
Intervention Name(s)
Salicylates
Primary Outcome Measure Information:
Title
To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.
Description
Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
evidence of skin plantar wart(s)
Exclusion Criteria:
iodine allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Grossman, DPM
Phone
610-645-6314
Email
michaelrgrossman@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Grossman, DPM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Main Line Foot and Ankle Center
City
Ardmore
State/Province
Pennsylvania
ZIP/Postal Code
19003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael R Grossman, DPM
Phone
610-645-6314
Email
michaelrgrossman@hotmail.com
First Name & Middle Initial & Last Name & Degree
Michael R Grossman, DPM
12. IPD Sharing Statement
Learn more about this trial
17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts
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