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

Graceway Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Genital Warts

Treatments: Drug: 3.75% imiquimod cream; Drug: Imiquimod; Drug: placebo cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00674739

GW01-0801

Details and patient eligibility

About

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.

Enrollment: 470 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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470 participants in 3 patient groups, including a placebo group

imiquimod cream

Experimental group

Description:

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

Treatment:

Drug: Imiquimod

3.75% imiquimod cream

Experimental group

Description:

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

Treatment:

Drug: 3.75% imiquimod cream

placebo cream

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo cream