Actinic Keratosis Clinical Trial
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
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).
Status | Completed |
Enrollment | 247 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Ultranova Skincare | Barrie | Ontario |
Canada | Clinique de Dermatologie | Moncton | New Brunswick |
Canada | Guildford Dermatology Specialists | Surrey | British Columbia |
Canada | Probity Medical Research | Waterloo | Ontario |
United States | Academic Dermatology Association | Albuquerque | New Mexico |
United States | DermResearch Inc. | Austin | Texas |
United States | Dermatology Treatment and Research Center | Dallas | Texas |
United States | Dermatology Research Associates | Los Angeles | California |
United States | MedaPhase, Inc. | Newman | Georgia |
United States | Skin Specialists PC | Omaha | Nebraska |
United States | Oregon Medical Research Center | Portland | Oregon |
United States | Progressive Clinical Research | San Antonio | Texas |
United States | Therapeutics Clinical Research | San Diego | California |
United States | Evanston Northwestern Healthcare | Skokie | Illinois |
United States | Spencer Dermatology & Skin Surgery Center | St. Petersberg | Florida |
United States | DermResearchCenter of New York | Stony Brook | New York |
United States | Palm Beach Dermatology | West Palm Beach | Florida |
United States | Wake Forest Univ School of Medicine | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Graceway Pharmaceuticals, LLC |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Percentage of Lesion Count | The primary efficacy endpoint was a comparison between the active and placebo treatment groups of percent change from baseline in the total AK lesion count at Week 26. All AK lesions on the face were included in the analysis—treated and untreated AK lesions at baseline (defined as the AK lesion count just prior to cryosurgery) and new lesions that appeared post-baseline. | Week 26 | No |
Secondary | Percent of Subjects With Complete Clearance | Proportion of subjects who achieved complete clearance of all AK lesions, cryosurgery-treated AK lesions, and non cryosurgery-treated AK lesions from baseline to Week 26/EOS in the ITT population. | Week 26 | No |
Secondary | Number of Participants With Any Post-baseline Local Skin Reactions (LSRs) | LSRs were assessed independently from AEs. The frequency and percentage of subjects, as well as the mean (SD) and median score for severity (none=0, mild=1, moderate=2, and severe=3), were summarized by treatment group and by visit for the following LSRs: erythema, edema, weeping/exudates, flaking/ scaling/dryness, and scabbing/crusting. Erosion and ulceration were also evaluated (none=0, erosion=1, and ulceration=2). A score of greater than 0 for the specified LSR was considered a "treatment site reaction". | Weeks 2, 4, 6, 10, 14, 20, and 26 | Yes |
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