Clinical trial NCT00603798: Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
Official title: A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Six Weeks of Treatment With Imiquimod Creams for Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Actinic keratosis
Dermatologic disease
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 490
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 shown to be safe and effective for the treatment of AKs.

Detailed description: These were a randomized, double-blind, multicenter, placebo-controlled studies 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 AK of the face or balding scalp. Subjects were scheduled for a total of 11 visits (1 prestudy screening visit and 10 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 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. 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 21 weeks, including a 4-week maximum screening period and a 17-week study period. At the End of Study (EOS) visit, eligible subjects may have been invited to participate in a separate study evaluating AK recurrence.

Eligibility criteria: Inclusion Criteria:

* In good general health.
* Have 5 to 20 AKs on the face or balding scalp.
* Negative pregnancy test (for women who are able to become pregnant).
* Willing to make frequent visits to the study center during the 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 (such as: 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 17 visit
Secondary outcomes:
measure: Number of Participants With Partial Clearance of AK Lesions
timeFrame: End of Study the Week 17 visit
measure: Percent Change From Baseline in AK Lesion Count
timeFrame: At all visits - Baseline through the Week 17 EOS visit
measure: Local Skin Reactions (LSR)
timeFrame: The time period for the AUC extends to 8 weeks after the end of treatment (Week 17)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Encino
country: United States
state: California
city: Vista
country: United States
state: California
city: New Britain
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Coral Gables
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Arlington Heights
country: United States
state: Illinois
city: Champaign
country: United States
state: Illinois
city: Carmel
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: South bend
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Omaha
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Woodbridge
country: United States
state: Virginia
Study officials:
affiliation: Graceway Pharmaceuticals
name: Sharon F Levy, MD
role: STUDY_DIRECTOR
References:
citation: Hanke CW, Beer KR, Stockfleth E, Wu J, Rosen T, 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 3-week cycles. J Am Acad Dermatol. 2010 Apr;62(4):573-81. doi: 10.1016/j.jaad.2009.06.020. Epub 2010 Feb 4.