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

Graceway Pharmaceuticals, LLC470 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

470

Conditions

Genital Warts

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (30)

WILMAX Clinical Research

Mobile, Alabama, United States

Montgomery Women's Health Associates

Montgomery, Alabama, United States

Women's Health Research

Phoenix, Arizona, United States

Precision Trials

Phoenix, Arizona, United States

Premier Pharmaceutical Research

Tempe, Arizona, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Up to 16 weeks

Secondary Outcomes

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

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.

Time frame: Up to 16 weeks

Treatment Related Adverse Events

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

Time frame: Up to 16 weeks