Phase 3 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: 2.5% imiquimod cream 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 Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts

Resource links provided by NLM:

MedlinePlus related topics: 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 Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.

Secondary Outcome Measures:

Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any 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 ]
Treatment related defined as "probably related" or "related" by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators.

Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction.


Enrollment:	511
Study Start Date:	August 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2.5% imiquimod cream 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks	Drug: 2.5% imiquimod cream 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks. Other Name: 2.5% imiquimod topical cream
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 topical cream

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
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 types 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735462

Show 43 Study Locations

Sponsors and Collaborators

Graceway Pharmaceuticals, LLC

Investigators


Study Director:	Jason Wu, MD	Graceway Pharmaceuticals

More Information


Responsible Party:	Jason Wu, MD / Executive Director, Product Development, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00735462 History of Changes
Other Study ID Numbers:	GW01-0805
Study First Received:	August 14, 2008
Results First Received:	April 24, 2011
Last Updated:	June 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:


external genital warts perianal warts condylomata acuminata human papilloma virus HPV types 6 and 11

Additional relevant MeSH terms:


Warts Condylomata Acuminata Papillomavirus Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Imiquimod Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers

ClinicalTrials.gov processed this record on September 23, 2016