Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery

NCT00894647 | Completed Phase 3 Results

• 1 other identifier: GW01-0901
• Study Type: interventional
• Target: 247
• Locations: 2 countries
• Sites: 18

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).

Conditions

Actinic Keratosis

Keywords

actinic keratosis; skin disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Percent of Subjects With Complete Clearance

  Week 26

• Number of Participants With Any Post-baseline Local Skin Reactions (LSRs)

  Weeks 2, 4, 6, 10, 14, 20, and 26

Study Arms (2)

2

PLACEBO COMPARATOR

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

Drug: placebo cream

imiquimod cream

ACTIVE COMPARATOR

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

Drug: imiquimod cream

Interventions

imiquimod cream 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

imiquimod cream

placebo cream DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Graceway Pharmaceuticals, LLC: lead

Study Sites (18)

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Spencer Dermatology & Skin Surgery Center

Saint Petersberg, Florida, 33705, United States

Location

Palm Beach Dermatology

West Palm Beach, Florida, 33401, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Evanston Northwestern Healthcare

Skokie, Illinois, 60077, United States

Location

Skin Specialists PC

Omaha, Nebraska, 68144, United States

Location

Academic Dermatology Association

Albuquerque, New Mexico, 87106, United States

Location

DermResearchCenter of New York

Stony Brook, New York, 11790, United States

Location

Wake Forest Univ School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

DermResearch Inc.

Austin, Texas, 78759, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78229, United States

Location

Guildford Dermatology Specialists

Surrey, British Columbia, V3R6A7, Canada

Location

Clinique de Dermatologie

Moncton, New Brunswick, E1C 8X3, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

Probity Medical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

MeSH Terms

Conditions

Keratosis, Actinic; Skin Diseases

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin and Connective Tissue Diseases

Limitations and Caveats

A treatment-emergent AE (TEAE) was an AE that began or worsened in severity after the first application of study drug. TEAEs were summarized for each treatment group by overall incidence, descending order, relationship to study drug, and severity.

Results Point of Contact

• Title: Vice President Medical Affairs
• Organization: Graceway Pharmaceuticals

Sharon.levy@gracewaypharma.com

267-948-0400

Study Officials

• Sharon Levy, MD

  Graceway Pharmaceuticals, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 7, 2009
• Study Start: May 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 31, 2010
• Results First Posted: August 23, 2010

Record last verified: 2010-08

Locations

US (14); CA (4)