Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
Information source: Graceway Pharmaceuticals, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Keratosis
Intervention: imiquimod cream (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Graceway Pharmaceuticals, LLC Official(s) and/or principal investigator(s): Sharon Levy, MD, Study Director, Affiliation: Graceway Pharmaceuticals
Summary
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 purpose of this
study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment
of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso,
and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The
secondary objective is to evaluate the effectiveness of treatment with imiquimod in people
with large surface areas of AK.
Clinical Details
Official title: Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants Who Experienced an Adverse Event
Secondary outcome: Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count
Detailed description:
This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects
aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational
sites in the United States.
This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging
from one packet 12. 5 mg) to 6 packets (75 mg) to either single or multiple body regions for
up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects
applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4
clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or
noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment
areas could be exposed (i. e., head, torso and/or extremities), with the number of packets
determined by the investigator but not to exceed one packet for each 25 cm2 treatment area,
up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for
16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month,
treatment-free follow-up period.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Are at least 18 years of age.
- Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic
keratosis lesions.
Exclusion Criteria:
- 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.
Locations and Contacts
Phoenix, Arizona 85044, United States
Encino, California 91436, United States
Los Angeles, California 90045, United States
Riverside, California 92506, United States
San Diego, California 92117, United States
Santa Monica, California 90404, United States
Denver, Colorado 80210, United States
New Britain, Connecticut 06052, United States
Coral Gables, Florida 33134, United States
Hollywood, Florida 33021, United States
Miami, Florida 33175, United States
West Palm Beach, Florida 33401, United States
Arlington Heights, Illinois 60005, United States
Indianapolis, Indiana 46256, United States
Metairie, Louisiana 70006, United States
Boston, Massachusetts 02118, United States
Chaska, Minnesota 55318, United States
Henderson, Nevada 89014, United States
Henderson, Nevada 89052, United States
Reno, Nevada 89509, United States
Reno, Nevada 89521, United States
New York, New York 10021, United States
High Point, North Carolina 27262, United States
Raleigh, North Carolina 27612, United States
Winston-Salem, North Carolina 27106, United States
Portland, Oregon 97210, United States
Flourtown, Pennsylvania 19031, United States
Arlington, Texas 76011, United States
San Antonio, Texas 78229, United States
Woodbridge, Virginia 22191, United States
Spokane, Washington 99204, United States
Milwaukee, Wisconsin 53207, United States
Additional Information
Starting date: June 2005
Last updated: July 14, 2010
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