Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts - Full Text View

Sponsored by:	Graceway Pharmaceuticals, LLC
Information provided by:	Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00674739

Purpose

The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams.

External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.

Condition	Intervention	Phase
Genital Warts	Drug: Imiquimod A Drug: Imiquimod B Drug: Placebo	Phase III

MedlinePlus related topics: Genital Warts Warts

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:

The primary efficacy endpoint is the proportion of subjects achieving complete clearance of all warts (baseline and new) at the EOS. [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety variables include adverse reactions (AEs), local skin reactions (LSRs), and number and duration of rest periods during the Treatment Period. [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	450
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Imiquimod A cream, 250 mg/packet, applied daily
2: Active Comparator	Drug: Imiquimod B cream, 250 mg/packet, applied daily
3: Placebo Comparator	Drug: Placebo cream, 250 mg/packet, applied daily

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

In good general health
Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts
Negative pregnancy test (for women who are able to become pregnant)

Exclusion Criteria:

Women who are pregnant, lactating or planning to become pregnant during the study
Evidence of clinically significant or unstable disease (such as stroke, heart attack)
Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalis in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas
Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674739

Show 30 Study Locations

Sponsors and Collaborators

Graceway Pharmaceuticals, LLC

Investigators

Study Director:

Sharon Levy, MD

Graceway Pharmaceuticals, LLC

More Information

Responsible Party:	Graceway Pharmaceuticals, LLC ( Sharon Levy, MD / Vice President, Product Development )
Study ID Numbers:	GW01-0801
Study First Received:	May 7, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00674739
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:

external genital warts
perianal warts
condylomata acuminata
venereal warts
HPV types 6 and 11

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Skin Diseases
Interferons
Condyloma
Imiquimod
Virus Diseases
Skin Diseases, Infectious

Warts
Condylomata Acuminata
Condyloma acuminatum
Sexually Transmitted Diseases
Papillomavirus Infections
DNA Virus Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Interferon Inducers
Neoplasms
Immunologic Factors
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Tumor Virus Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009