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17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712295
Recruitment Status : Unknown
Verified October 2012 by Grossman, Michael, D.P.M..
Recruitment status was:  Recruiting
First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Main Line Health
Information provided by (Responsible Party):
Grossman, Michael, D.P.M.

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.

Condition or disease Intervention/treatment Phase
Warts Drug: 17% Salicylate with ethyl pyruvate Drug: Salicylates Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: New Formulation of Salicylate to Improve Treatment of Common Skin Warts
Study Start Date : November 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health Warts

Arm Intervention/treatment
Experimental: 17% Salicylate with Ethyl Pyruvate
Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks.
Drug: 17% Salicylate with ethyl pyruvate
Other Name: Compound W

Active Comparator: 17% salicylate
subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks
Drug: Salicylates

Primary Outcome Measures :
  1. To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone. [ Time Frame: 16 weeks ]
    Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • evidence of skin plantar wart(s)

Exclusion Criteria:

  • iodine allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712295

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Contact: Michael Grossman, DPM 610-645-6314

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United States, Pennsylvania
Main Line Foot and Ankle Center Recruiting
Ardmore, Pennsylvania, United States, 19003
Contact: Michael R Grossman, DPM    610-645-6314   
Principal Investigator: Michael R Grossman, DPM         
Sponsors and Collaborators
Grossman, Michael, D.P.M.
Main Line Health
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Principal Investigator: Michael R Grossman, DPM
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Responsible Party: Grossman, Michael, D.P.M. Identifier: NCT01712295    
Other Study ID Numbers: R12-3128
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012
Keywords provided by Grossman, Michael, D.P.M.:
salicylic acid
ethyl pyruvate
Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents