Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00605176
First received: January 16, 2008
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp.

Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has been shown to be safe and effective for the treatment of AKs.


Condition Intervention Phase
Actinic Keratoses
Drug: imiquimod cream
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Four Weeks of Treatment With Imiquimod Creams for Actinic Keratoses

Resource links provided by NLM:


Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Number of Participants With Complete Clearance of AK Lesions [ Time Frame: End of Study the Week 14 visit ] [ Designated as safety issue: No ]
    Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 14 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or 'subclinical' lesion that had not been identified at Baseline.


Secondary Outcome Measures:
  • Number of Participants With Partial Clearance of AK Lesions [ Time Frame: End of Study the Week 14 visit ] [ Designated as safety issue: No ]
    Subject status with respect to partial clearance of AK lesions at end of study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.

  • Percent Change From Baseline in AK Lesion Count [ Time Frame: From baseline to End of Study the Week 14 visit ] [ Designated as safety issue: No ]
    Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions.

  • Local Skin Reactions [ Time Frame: At all visits - from Baseline to End of study (Week 14) ] [ Designated as safety issue: Yes ]
    Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each study visit. These included: Erythema, Edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Mean scores were summated over time (14 weeks) to yield a mean LSR AUC (area under the curve)


Enrollment: 479
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3.75% imiquimod cream Drug: imiquimod cream
cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
Active Comparator: 2.5% imiquimod cream Drug: imiquimod cream
cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
Placebo Comparator: Placebo cream Drug: Placebo
cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.

Detailed Description:

This was a randomized, double-blind, multicenter, placebo-controlled study that compared the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo in the treatment of typical visible or palpable AKs of the face or balding scalp. Subjects were scheduled for a total of 9 visits (1 prestudy screening visit and 8 on-study visits). Subjects determined to be eligible during the screening phase were randomized in a 1:1:1 ratio to 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream. The creams were applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment. The investigator selected the treatment area for the study (either the entire face or the entire balding scalp, but not both). Subjects applied a thin layer of cream to the treatment area (up to 2 packets, or 500 mg of product, per application), avoiding the periocular areas, lips, and nares. Study medication was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. Ears were excluded from both assessment and treatment. Rest periods from daily treatment were instituted by the investigator as needed to manage local skin reactions (LSRs) or application site reactions, with resumption of treatment upon adequate resolution as determined by the investigator.

The duration of each subject's study participation was approximately 18 weeks, including a 4-week maximum screening period and a 14-week study period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In good general health
  • Have 5 to 20 AKs on the face or balding scalp
  • Negative urine pregnancy test (for women who are able to become pregnant)
  • Willing to make frequent visits to the study center during treatment and follow-up periods.

Exclusion Criteria:

  • Women who are pregnant, lactating or planning to become pregnant during the study.
  • Have had a medical event within 90 days of the first visit (such as; stroke, heart attack).
  • 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(s) within the designated time period prior to study treatment initiation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605176

  Show 26 Study Locations
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
Investigators
Study Director: Sharon F Levy, MD Graceway Pharmaceuticals
  More Information

Publications:
Responsible Party: Vice President, Product Development, Clinical, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00605176     History of Changes
Other Study ID Numbers: GW01-0702 / 0704
Study First Received: January 16, 2008
Results First Received: April 15, 2010
Last Updated: June 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
Actinic keratosis
Skin disease

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on September 18, 2014