Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Condylomata Acuminata

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

2.5% imiquimod cream applied daily to wart area for up to 8 weeks

3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.

placebo cream applied daily to wart areas for up to 8 weeks

daily topical application for up to 8 weeks

3.75% imiquimod cream

placebo cream

Jason Wu, MD

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.

Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts

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.

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.

Numbers of subjects in each treatment group reporting one or more adverse events

Graceway Pharmaceuticals, LLC

Jason Wu, MD / Exective Director, Product Development

The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months

2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks

2.5% Imiquimod Cream

3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks

3.75% Imiquimod Cream

Placebo cream applied once daily to wart areas for up to 8 weeks

Placebo

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Robert Babilon, Vice President, Product Development

Adverse Reactions

Local Skin Reactions

Number of Subjects with Rest Period in Treatment

Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.

Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study

Patients with adverse events considered probably related or related to the administration of the product.

Treatment Related Adverse Events

Overall Study

Neoplasms

Papilloma

2.5% imiquimod cream applied daily to wart areas for up to 8 weeks

Placebo cream applied daily to wart areas for up to 8 weeks.

2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.

2.5% imiquimod cream

3.75% imiquimod cream applied daily to wart areas for up to 8 weeks

Placebo cream applied daily to wart areas for up to 8 weeks

Placebo cream

Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts

A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts

The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.

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.

Jason Wu, MD / Executive Director, Product Development

The study period included 4 month enrollment, maximum 28 weeks of study phase, so total length of the study from first patient enrolled to last patient completed the study is about 11 months.

2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.

3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.

Placebo cream applied once daily to wart areas for up to 8 weeks.

There was a high percentage of lost to follow up in this study. Since the disease studied in this study can be wait and watch, typically a high lost to follow up rate were seen in these kind of trials.

Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.

Subjects with and Adverse Reactions (ARs)

Subjects with Any Local Skin Reactions (LSRs)

Number of Subjects who Took a Rest Period

Analysis population was based on safety population which defined as for all subjects randomized and received at lease one dose. There was one subject who randomized to the 2.5% group but received one treatment kit of 3.75% imiq cream, so this subject was assigned to 3.75% for the safety analysis.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts	NCT00674739	Genital Warts	Imiquimod 3.75% imiquimod... placebo cream	12 Years -	Graceway Pharmaceuticals, LLC
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts	NCT00674739	Genital Warts	Imiquimod 3.75% imiquimod... placebo cream	12 Years -	Graceway Pharmaceuticals, LLC
Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts	NCT00735462	Genital Warts	2.5% imiquimod ... 3.75% imiquimod... Placebo cream	12 Years -	Graceway Pharmaceuticals, LLC
Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts	NCT00735462	Genital Warts	2.5% imiquimod ... 3.75% imiquimod... Placebo cream	12 Years -	Graceway Pharmaceuticals, LLC

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