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

Warts Clinical Trial

Official title:

New Formulation of Salicylate to Improve Treatment of Common Skin Warts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01712295
• Other study ID #: R12-3128
• Status: Recruiting
• Phase: Phase 4
• First received: October 19, 2012
• Last updated: October 22, 2012
• Start date: November 2011
• Est. completion date: March 2014

Study information

• Verified date: October 2012
• Source: Grossman, Michael, D.P.M.
• Contact: Michael Grossman, DPM
• Phone: 610-645-6314
• Email: michaelrgrossman[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• evidence of skin plantar wart(s)

Exclusion Criteria:

• iodine allergy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Warts

Intervention

Drug:
• 17% Salicylate with ethyl pyruvate

• Salicylates

Locations

Country	Name	City	State
United States	Main Line Foot and Ankle Center	Ardmore	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Grossman, Michael, D.P.M.	Main Line Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.	Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.	16 weeks	No
Secondary	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.		16 weeks	Yes