17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts
Recruitment status was: Recruiting
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.
|Warts||Drug: 17% Salicylate with ethyl pyruvate Drug: Salicylates||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||New Formulation of Salicylate to Improve Treatment of Common Skin Warts|
- 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.
- 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 ]
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712295
|Contact: Michael Grossman, DPMfirstname.lastname@example.org|
|United States, Pennsylvania|
|Main Line Foot and Ankle Center||Recruiting|
|Ardmore, Pennsylvania, United States, 19003|
|Contact: Michael R Grossman, DPM 610-645-6314 email@example.com|
|Principal Investigator: Michael R Grossman, DPM|
|Principal Investigator:||Michael R Grossman, DPM|