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

NCT ID: NCT01712295

Last Updated: 2012-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Warts

Keywords

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Warts salicylic acid ethyl pyruvate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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17% Salicylate with Ethyl Pyruvate

Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks.

Group Type EXPERIMENTAL

17% Salicylate with ethyl pyruvate

Intervention Type DRUG

17% salicylate

subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks

Group Type ACTIVE_COMPARATOR

Salicylates

Intervention Type DRUG

Interventions

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17% Salicylate with ethyl pyruvate

Intervention Type DRUG

Salicylates

Intervention Type DRUG

Other Intervention Names

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Compound W

Eligibility Criteria

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Inclusion Criteria

* evidence of skin plantar wart(s)

Exclusion Criteria

* iodine allergy
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Main Line Health

OTHER

Sponsor Role collaborator

Grossman, Michael, D.P.M.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael R Grossman, DPM

Role: PRINCIPAL_INVESTIGATOR

Locations

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Main Line Foot and Ankle Center

Ardmore, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Grossman, DPM

Role: CONTACT

Phone: 610-645-6314

Email: [email protected]

Facility Contacts

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Michael R Grossman, DPM

Role: primary

Other Identifiers

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R12-3128

Identifier Type: -

Identifier Source: org_study_id