Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs) - Full Text View

Sponsored by:	Graceway Pharmaceuticals, LLC
Information provided by:	Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00605176

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 A Drug: Imiquimod B Drug: Placebo	Phase III

MedlinePlus related topics: Skin Conditions

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:

Complete clearance rate [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Partial clearance rate [ Time Frame: End of Study ] [ Designated as safety issue: No ]
AK counts and change from baseline [ Time Frame: At all visits ] [ Designated as safety issue: No ]
Safety variables: adverse events and local skin reactions [ Time Frame: At all visits ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	480
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
1: Active Comparator	Drug: Imiquimod A cream, 250 mg/packet, applied daily
2: Active Comparator	Drug: Imiquimod B cream, 250 mg/packet, applied daily
3: Placebo Comparator	Drug: Placebo cream, 250 mg/packet, applied daily

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

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, LLC

More Information

Responsible Party:	Graceway Pharmaceuticals ( Vice President, Product Development, Clinical )
Study ID Numbers:	GW01-0702 / 0704
Study First Received:	January 16, 2008
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00605176
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:

Actinic keratosis
Skin disease

Study placed in the following topic categories:

Keratosis
Skin Diseases
Interferons
Imiquimod
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 January 14, 2009