490
Participants
Start Date
January 31, 2008
Primary Completion Date
July 31, 2008
Study Completion Date
July 31, 2008
Imiquimod cream
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
Placebo cream
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
Imiquimod cream
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
Philadelphia
Woodbridge
Norfolk
Coral Gables
West Palm Beach
Birmingham
Nashville
Louisville
Carmel
South Bend
Evansville
Arlington Heights
Champaign
Omaha
Little Rock
Dallas
Houston
Houston
San Antonio
Albuquerque
Reno
Encino
Vista
Portland
New Britain
New Haven
Lead Sponsor
Graceway Pharmaceuticals, LLC
INDUSTRY