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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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