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

Phase 4

• Conditions: Warts
• Interventions: Drug: 17% Salicylate with ethyl pyruvate; Drug: Salicylates

• Registration Number: NCT01712295
• Lead Sponsor: Grossman, Michael, D.P.M.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Status Verified: 2012-10
• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2012-10-22
• Last Update Submitted: 2012-10-22
• Study First Posted: 2012-10-23
• Last Update Posted: 2012-10-23
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• evidence of skin plantar wart(s)

Exclusion Criteria

• iodine allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
17% Salicylate with Ethyl Pyruvate	17% Salicylate with ethyl pyruvate	Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks.
17% salicylate	Salicylates	subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks

Primary Outcome Measures

Name	Time	Method
To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.	16 weeks	Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Main Line Foot and Ankle Center; 🇺🇸 Ardmore, Pennsylvania, United States