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

This study is currently recruiting participants.
Verified October 2012 by Grossman, Michael, D.P.M.
Sponsor:
Collaborator:
Main Line Health
Information provided by (Responsible Party):
Grossman, Michael, D.P.M.
ClinicalTrials.gov Identifier:
NCT01712295
First received: October 19, 2012
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: New Formulation of Salicylate to Improve Treatment of Common Skin Warts

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Warts
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • evidence of skin plantar wart(s)

Exclusion Criteria:

  • iodine allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712295

Contacts
Contact: Michael Grossman, DPM 610-645-6314 michaelrgrossman@hotmail.com

Locations
United States, Pennsylvania
Main Line Foot and Ankle Center Recruiting
Ardmore, Pennsylvania, United States, 19003
Contact: Michael R Grossman, DPM     610-645-6314     michaelrgrossman@hotmail.com    
Principal Investigator: Michael R Grossman, DPM            
Sponsors and Collaborators
Grossman, Michael, D.P.M.
Main Line Health
Investigators
Principal Investigator: Michael R Grossman, DPM
  More Information

No publications provided

Responsible Party: Grossman, Michael, D.P.M.
ClinicalTrials.gov Identifier: NCT01712295     History of Changes
Other Study ID Numbers: R12-3128
Study First Received: October 19, 2012
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases
Salicylates
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 22, 2013