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

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 Drug: 3.75% imiquimod cream Drug: placebo cream	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Genital Warts Warts

Drug Information available for: Imiquimod

U.S. FDA Resources

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:

Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.

Secondary Outcome Measures:

Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]
Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.

Rest period was a temporary interruption of dosing dur to intolerable LSRs.
Treatment Related Adverse Events [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]
Numbers of subjects in each treatment group reporting one or more adverse events

Enrollment:	470
Study Start Date:	May 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: imiquimod cream 2.5% imiquimod cream applied daily to wart area for up to 8 weeks	Drug: Imiquimod daily topical application for up to 8 weeks Other Name: imiquimod 2.5% topical creram
Experimental: 3.75% imiquimod cream 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.	Drug: 3.75% imiquimod cream 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. Other Name: 3.75% imiquimod topical cream
Placebo Comparator: placebo cream placebo cream applied daily to wart areas for up to 8 weeks	Drug: placebo cream placebo cream applied daily to wart areas for up to 8 weeks Other Name: placebo matching cream

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 genitalia 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:

Jason Wu, MD

Graceway Pharmaceuticals

More Information

No publications provided

Responsible Party:	Jason Wu, MD / Exective Director, Product Development, Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00674739 History of Changes
Other Study ID Numbers:	GW01-0801
Study First Received:	May 7, 2008
Results First Received:	April 24, 2011
Last Updated:	May 19, 2011
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

Additional relevant MeSH terms:

Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious

Skin Diseases
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on May 16, 2013