Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00894647
First received: May 5, 2009
Last updated: August 23, 2010
Last verified: August 2010

May 5, 2009
August 23, 2010
May 2009
February 2010   (final data collection date for primary outcome measure)
Change From Baseline in Percentage of Lesion Count [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
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.
Percent change from baseline in total AK lesion count [ Time Frame: Visit 9 / Week 26 / End of Study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00894647 on ClinicalTrials.gov Archive Site
  • Percent of Subjects With Complete Clearance [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Proportion of subjects who achieved complete clearance of all AK lesions, cryosurgery-treated AK lesions, and non cryosurgery-treated AK lesions from baseline to Week 26/EOS in the ITT population.
  • Number of Participants With Any Post-baseline Local Skin Reactions (LSRs) [ Time Frame: Weeks 2, 4, 6, 10, 14, 20, and 26 ] [ Designated as safety issue: Yes ]
    LSRs were assessed independently from AEs. The frequency and percentage of subjects, as well as the mean (SD) and median score for severity (none=0, mild=1, moderate=2, and severe=3), were summarized by treatment group and by visit for the following LSRs: erythema, edema, weeping/exudates, flaking/ scaling/dryness, and scabbing/crusting. Erosion and ulceration were also evaluated (none=0, erosion=1, and ulceration=2). A score of greater than 0 for the specified LSR was considered a "treatment site reaction".
  • Proportion of subjects with complete clearance [ Time Frame: All post-baseline visits ] [ Designated as safety issue: No ]
  • Percentage of adverse reactions (AEs), local skin reactions (LSRs), and rest periods during the treatment period [ Time Frame: All post base-line visits ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actinic Keratosis
  • Drug: 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
  • 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
  • Placebo Comparator: 2
    placebo cream in 250mg/packet, up to 2 packets applied daily
    Intervention: Drug: placebo cream
  • Active Comparator: imiquimod cream
    Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
    Intervention: Drug: imiquimod cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
247
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00894647
GW01-0901
No
Sharon Levy, MD, Graceway Pharmaceuticals, LLC
Graceway Pharmaceuticals, LLC
Not Provided
Study Director: Sharon Levy, MD Graceway Pharmaceuticals, LLC
Graceway Pharmaceuticals, LLC
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP