Clinical trial NCT00605176: Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)
Official title: A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Four Weeks of Treatment With Imiquimod Creams for Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratoses
Keywords: Actinic keratosis
Skin disease
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp.

Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has been shown to be safe and effective for the treatment of AKs.

Detailed description: This was a randomized, double-blind, multicenter, placebo-controlled study that compared the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo in the treatment of typical visible or palpable AKs of the face or balding scalp. Subjects were scheduled for a total of 9 visits (1 prestudy screening visit and 8 on-study visits). Subjects determined to be eligible during the screening phase were randomized in a 1:1:1 ratio to 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream. The creams were 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. The investigator selected the treatment area for the study (either the entire face or the entire balding scalp, but not both). Subjects applied a thin layer of cream to the treatment area (up to 2 packets, or 500 mg of product, per application), avoiding the periocular areas, lips, and nares. Study medication was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. Ears were excluded from both assessment and treatment. Rest periods from daily treatment were instituted by the investigator as needed to manage local skin reactions (LSRs) or application site reactions, with resumption of treatment upon adequate resolution as determined by the investigator.

The duration of each subject's study participation was approximately 18 weeks, including a 4-week maximum screening period and a 14-week study period.

Eligibility criteria: Inclusion Criteria:

* In good general health
* Have 5 to 20 AKs on the face or balding scalp
* Negative urine pregnancy test (for women who are able to become pregnant)
* Willing to make frequent visits to the study center during treatment and follow-up periods.

Exclusion Criteria:

* Women who are pregnant, lactating or planning to become pregnant during the study.
* Have had a medical event within 90 days of the first visit (such as; stroke, heart attack).
* Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
* Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.

Primary outcomes:
measure: Number of Participants With Complete Clearance of AK Lesions
timeFrame: End of Study the Week 14 visit
Secondary outcomes:
measure: Number of Participants With Partial Clearance of AK Lesions
timeFrame: End of Study the Week 14 visit
measure: Percent Change From Baseline in AK Lesion Count
timeFrame: From baseline to End of Study the Week 14 visit
measure: Local Skin Reactions
timeFrame: At all visits - from Baseline to End of study (Week 14)
Other outcomes:
Locations:
city: Fremont
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Vallejo
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Newman
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Springfield
country: United States
state: Illinois
city: Dubuque
country: United States
state: Iowa
city: Olathe
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Marrero
country: United States
state: Louisiana
city: Henderson
country: United States
state: Nevada
city: Rochester
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Lynchburg
country: United States
state: Virginia
Study officials:
affiliation: Graceway Pharmaceuticals
name: Sharon F Levy, MD
role: STUDY_DIRECTOR
References:
citation: Swanson N, Abramovits W, Berman B, Kulp J, Rigel DS, Levy S. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles. J Am Acad Dermatol. 2010 Apr;62(4):582-90. doi: 10.1016/j.jaad.2009.07.004. Epub 2010 Feb 4.