Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)

PHASE3CompletedINTERVENTIONAL
Enrollment

479

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
Actinic Keratoses
Interventions
DRUG

imiquimod cream

cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.

DRUG

imiquimod cream

cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.

DRUG

Placebo

cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.

Trial Locations (26)

14623

Rochester

24501

Lynchburg

27106

Winston-Salem

27262

High Point

30263

Newnan

33144

Miami

37215

Nashville

52002

Dubuque

62703

Springfield

66061

Olathe

67206

Wichita

70072

Marrero

75230

Dallas

77056

Houston

78229

San Antonio

78759

Austin

83704

Boise

84088

West Jordan

84124

Salt Lake City

89052

Henderson

90045

Los Angeles

92117

San Diego

92506

Riverside

94538

Fremont

94589

Vallejo

97239

Portland

Sponsors
All Listed Sponsors
lead

Graceway Pharmaceuticals, LLC

INDUSTRY