Clinical trial NCT00894647: Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery
Official title: A Phase 3b Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Imiquimod Cream Following Cryosurgery for the Treatment of Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: actinic keratosis
skin disease
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 247
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 objective of this study is to evaluate the efficacy and safety of imiquimod cream versus placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).

Detailed description: In this multicenter, randomized, double-blind, placebo-controlled study, the efficacy and safety of imiquimod 3.75% cream following cryosurgery to treat clinically typical visible or palpable AK lesions on the face was compared with that of placebo cream. Based on a 1:1 randomization, approximately 120 subjects applied imiquimod 3.75% cream daily (up to 500 mg cream daily \[18.75 mg imiquimod\]) and approximately 120 subjects applied placebo cream daily during two 2-week periods (Cycle 1 and Cycle 2) separated by 2 weeks of no treatment. Subjects visited the clinic 9 times-1 screening/cryosurgery visit (additional visits might be needed during the screening period to assess healing from the cryosurgery), 4 treatment visits(treatment initiation at Weeks 0 and 4 and treatment follow-up at the end of Weeks 2 and 6), and 4 posttreatment visits (4, 8, 14, and 20 weeks after the last administration of study treatment at the end of Week 6). The total study duration for a subject, including a 2-week screening period, was up to 28 weeks.

Prior to cryosurgery, subjects had to have ≥10 clinically typical visible or palpable AK lesions in an area that exceeded 25 cm\^2 on the face to be eligible for participation in the study. At screening, a minimum of 5 visible lesions were not treated with cryosurgery, and 5 to 14 visible lesions were treated with cryosurgery. Subjects had to have at least 5 AK lesions after the skin healed sufficiently from the cryosurgery to be eligible for randomization to either imiquimod 3.75% or placebo cream. Subjects applied up to 2 packets of study cream (500 mg total) as a thin layer to the entire face, avoiding the periocular areas, lips, and nares; ears were excluded from both assessment and treatment. Study cream was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. Rest periods from daily treatment could be approved by the investigator as needed, with treatment resumption at the investigator's discretion.

Eligibility criteria: Inclusion Criteria:

* In good general health
* Negative urine pregnancy test (for women of child-bearing potential) and agree to use an approved method of birth control while enrolled in the study.
* Prior to cryosurgery, have ≥ 10 clinically typical (visible or palpable) AKs in an area that exceeds 25 cm2 on the face.
* Must have had cryosurgery on 5 to 14 AKs on the face after giving informed consent and prior to receiving study medication. Lesions previously treated with cryosurgery must be healed sufficiently prior to randomization to study cream.
* Following cryosurgery, have ≥ 5 clinically typical (visible or palpable) AKs in an area that exceeds 25 cm2 on the face that are suitable for treatment with the study cream.

Exclusion Criteria:

* Women who are pregnant, lactating, or planning to become pregnant during the study
* Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.).
* 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 within the designated time period prior to study treatment initiation

Primary outcomes:
measure: Change From Baseline in Percentage of Lesion Count
timeFrame: Week 26
Secondary outcomes:
measure: Percent of Subjects With Complete Clearance
timeFrame: Week 26
measure: Number of Participants With Any Post-baseline Local Skin Reactions (LSRs)
timeFrame: Weeks 2, 4, 6, 10, 14, 20, and 26
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: St. Petersberg
country: United States
facility: Spencer Dermatology & Skin Surgery Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Dermatology
state: Florida
city: Newman
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Skokie
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Association
state: New Mexico
city: Stony Brook
country: United States
facility: DermResearchCenter of New York
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Univ School of Medicine
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Austin
country: United States
facility: DermResearch Inc.
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Surrey
country: Canada
facility: Guildford Dermatology Specialists
state: British Columbia
city: Moncton
country: Canada
facility: Clinique de Dermatologie
state: New Brunswick
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Waterloo
country: Canada
facility: Probity Medical Research
state: Ontario
Study officials:
affiliation: Graceway Pharmaceuticals, LLC
name: Sharon Levy, MD
role: STUDY_DIRECTOR
References: