Recruiting

17% Salicylate vs. 17% Salicylate-Ethyl Pyruvate

Sponsor:

Grossman, Michael, D.P.M.

Code:

NCT01712295

Conditions

Warts

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

17% Salicylate with ethyl pyruvate

Salicylates

Study Details

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.

Conditions

Warts

Study ID

NCT01712295

Start date

Nov, 2011

Status verified date

Oct, 2012

Completion date

Mar, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • evidence of skin plantar wart(s)

Exclusion Criteria:

  • iodine allergy

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

Interventions

17% Salicylate with ethyl pyruvate

Salicylates

Primary outcome measure

  • To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone. [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Locations

Main Line Foot and Ankle Center

Recruiting

Ardmore, Pennsylvania, United States, 19003

Contacts

Principal Investigator:

Michael R Grossman, DPM

More Information

Sponsor

Grossman, Michael, D.P.M.

Last update posted

Oct 23, 2012

Last verified

Oct, 2012

Keywords

  • Warts
  • salicylic acid
  • ethyl pyruvate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Grossman, Michael, D.P.M. on 2012-10-23.