Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery

NCT ID: NCT00894647

Last Updated: 2010-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-02-28

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.

Conditions

Actinic Keratosis

Keywords

actinic keratosis; skin disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

2

placebo cream in 250mg/packet, up to 2 packets applied daily

Group Type: PLACEBO_COMPARATOR

placebo cream

Intervention Type: DRUG

cream applied once daily for two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period

imiquimod cream

Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily

Group Type: ACTIVE_COMPARATOR

imiquimod cream

Intervention Type: DRUG

Imiquimod 3.75% cream (250 mg/packet) up to 2 packets applied daily Two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period

Interventions

imiquimod cream

Imiquimod 3.75% cream (250 mg/packet) up to 2 packets applied daily Two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period

Intervention Type: DRUG

placebo cream

cream applied once daily for two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Graceway Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Graceway Pharmaceuticals, LLC

Principal Investigators

Sharon Levy, MD

Role: STUDY_DIRECTOR

Graceway Pharmaceuticals, LLC

Locations

Dermatology Research Associates

Los Angeles, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Spencer Dermatology & Skin Surgery Center

Saint Petersberg, Florida, United States

Palm Beach Dermatology

West Palm Beach, Florida, United States

MedaPhase, Inc.

Newnan, 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

Countries

United States; Canada

Other Identifiers

GW01-0901

Identifier Type: -

Identifier Source: org_study_id