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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Sharon Levy, MD
Affiliation: Graceway Pharmaceuticals, LLC
Role: STUDY_DIRECTOR