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Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults

Primary Purpose

Warts

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Resiquimod
Sponsored by
Graceway Pharmaceuticals, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warts focused on measuring Wart(s), Adults, Common Wart(s)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of common warts Two forms of birth control Exclusion Criteria: Pregnant or breast feeding Other types of warts, ie. plantar Currently participating in another clinical study Chronic viral hepatitis B or C

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Clearance of treated wart(s)

    Secondary Outcome Measures

    Partial clearance of treated wart(s)
    Wart recurrence

    Full Information

    First Posted
    June 21, 2005
    Last Updated
    February 16, 2007
    Sponsor
    Graceway Pharmaceuticals, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00115141
    Brief Title
    Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults
    Official Title
    A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Graceway Pharmaceuticals, LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks. A second purpose is to evaluate the safety of the drug.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Warts
    Keywords
    Wart(s), Adults, Common Wart(s)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    Single
    Allocation
    Non-Randomized
    Enrollment
    88 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Resiquimod
    Primary Outcome Measure Information:
    Title
    Clearance of treated wart(s)
    Secondary Outcome Measure Information:
    Title
    Partial clearance of treated wart(s)
    Title
    Wart recurrence

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of common warts Two forms of birth control Exclusion Criteria: Pregnant or breast feeding Other types of warts, ie. plantar Currently participating in another clinical study Chronic viral hepatitis B or C

    12. IPD Sharing Statement

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    Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults

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