Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Keratosis	Drug: imiquimod cream	Phase IV

ChemIDplus related topics:

S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:

To evaluate the safety of 1, 2, or 3 16-week cycles of imiquimod for the treatment of actinic keratosis lesions totaling greater than 25 square centimeters

Secondary Outcome Measures:

To evaluate the efficacy of treatment with imiquimod in this population of subjects with actinic keratosis

Estimated Enrollment:	500
Study Start Date:	June 2005
Estimated Study Completion Date:	May 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116649

Show 32 Study Locations

Sponsors and Collaborators

Graceway Pharmaceuticals, LLC

More Information

Study ID Numbers:	1520-IMIQ
First Received:	June 30, 2005
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00116649
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:

actinic keratosis lesions large head torso extremities

actinic keratosis

Study placed in the following topic categories:

Keratosis

Skin Diseases

Arnold-Chiari Malformation

Interferons

Arnold-Chiari malformation

Imiquimod

Interferon Alfa-2b

Tylosis

Additional relevant MeSH terms:

Interferon Inducers

Immunologic Factors

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Adjuvants, Immunologic

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Graceway Pharmaceuticals, LLC
Information provided by:	Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00116649