Clinical trial NCT00116649: Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
Official title: Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratosis
Keywords: actinic keratosis lesions large head torso extremities
actinic keratosis
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.

Detailed description: This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States.

This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.

Eligibility criteria: Inclusion Criteria:

* Are at least 18 years of age.
* Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.

Exclusion Criteria:

* 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 Who Experienced an Adverse Event
timeFrame: from first dose up to 18 months
Secondary outcomes:
measure: Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count
timeFrame: At Month 18
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Encino
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: Santa Monica
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Britain
country: United States
state: Connecticut
city: Coral Gables
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Arlington Heights
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Metairie
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Chaska
country: United States
state: Minnesota
city: Henderson
country: United States
state: Nevada
city: Henderson
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Flourtown
country: United States
state: Pennsylvania
city: Arlington
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Woodbridge
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Graceway Pharmaceuticals
name: Sharon Levy, MD
role: STUDY_DIRECTOR
References:
citation: Del Rosso JQ, Sofen H, Leshin B, Meng T, Kulp J, Levy S. Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses. J Clin Aesthet Dermatol. 2009 Apr;2(4):20-8.