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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

Page last updated: August 23, 2015

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