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Spots Global Cancer Trial Database for Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery

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Trial Identification

Brief Title: 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 ID: NCT00894647

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dermatology Research Associates, Los Angeles, California, United States

Therapeutics Clinical Research, San Diego, California, United States

Spencer Dermatology & Skin Surgery Center, St. Petersberg, Florida, United States

Palm Beach Dermatology, West Palm Beach, Florida, United States

MedaPhase, Inc., Newman, Georgia, United States

Evanston Northwestern Healthcare, Skokie, Illinois, United States

Skin Specialists PC, Omaha, Nebraska, United States

Academic Dermatology Association, Albuquerque, New Mexico, United States

DermResearchCenter of New York, Stony Brook, New York, United States

Wake Forest Univ School of Medicine, Winston-Salem, North Carolina, United States

Oregon Medical Research Center, Portland, Oregon, United States

DermResearch Inc., Austin, Texas, United States

Dermatology Treatment and Research Center, Dallas, Texas, United States

Progressive Clinical Research, San Antonio, Texas, United States

Guildford Dermatology Specialists, Surrey, British Columbia, Canada

Clinique de Dermatologie, Moncton, New Brunswick, Canada

Ultranova Skincare, Barrie, Ontario, Canada

Probity Medical Research, Waterloo, Ontario, Canada

Contact Details

Name: Sharon Levy, MD

Affiliation: Graceway Pharmaceuticals, LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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