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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Grossman, Michael, D.P.M..
Recruitment status was:  Recruiting
Main Line Health
Information provided by (Responsible Party):
Grossman, Michael, D.P.M. Identifier:
First received: October 19, 2012
Last updated: October 22, 2012
Last verified: October 2012

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 Intervention Phase
Warts Drug: 17% Salicylate with ethyl pyruvate Drug: Salicylates Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Grossman, Michael, D.P.M.:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

Inclusion Criteria:

  • evidence of skin plantar wart(s)

Exclusion Criteria:

  • iodine allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01712295

Contact: Michael Grossman, DPM 610-645-6314

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
Principal Investigator: Michael R Grossman, DPM
  More Information

Responsible Party: Grossman, Michael, D.P.M. Identifier: NCT01712295     History of Changes
Other Study ID Numbers: R12-3128
Study First Received: October 19, 2012
Last Updated: October 22, 2012

Keywords provided by Grossman, Michael, D.P.M.:
salicylic acid
ethyl pyruvate

Additional relevant MeSH terms:
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 processed this record on September 19, 2017