Twelve Week Safety and Efficacy Study With a Topical Gel... | NCT00114920

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

NCT00114920

Sponsor

Graceway Pharmaceuticals, LLC

Status

Completed

Last Update Posted

Feb 19, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Warts

Interventions

Resiquimod

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 20, 2005

First Submission Date that Met QC Criteria

Jun 20, 2005

First Posted Date

Jun 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2007

Last Update Posted Date

Feb 19, 2007Estimated

Description Module

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 twelve weeks.

A second purpose is to evaluate the safety of the drug.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Resiquimod	Drug

Measure	Description	Time Frame
Clearance of treated common wart(s)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of common warts
Two forms of birth control

Exclusion Criteria:

Pregnant or breast feeding
Other types of wart(s), ie. plantar
Currently participating in another clinical study
Chronic viral hepatitis B or C

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Welborn Clinic		Evansville	Indiana	47713	United States

Condition Browse Module

MeSH Terms

ID	Term
D014860	Warts

Ancestor Terms

ID	Term
D030361	Papillomavirus Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided