Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses - Full Text View

Sponsors and Collaborators:	Rigel Dermatology Graceway Pharmaceuticals, LLC
Information provided by:	Rigel Dermatology
ClinicalTrials.gov Identifier:	NCT00774787

Purpose

The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) at follow-up.

Condition	Intervention	Phase
Actinic Keratoses	Drug: imiquimod 5% cream Drug: Untreated	Phase IV

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Efficacy Study
Official Title:	A Randomized, Open-Label, Assessor-Blinded, Split-Face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses

Further study details as provided by Rigel Dermatology:

Primary Outcome Measures:

Change from baseline in number of total actinic keratoses on the imiquimod-treated side versus the untreated side after cryotherapy [ Time Frame: 8 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in number of target (lesions treated with cryotherapy) actinic keratoses on the imiquimod-treated side versus the untreated side after cryotherapy [ Time Frame: 8 weeks post-treatment ] [ Designated as safety issue: No ]
Cosmetic appearance of imiquimod-treated side versus the untreated side [ Time Frame: 8 weeks post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Imiquimod, treatment, topical cream: Experimental Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp	Drug: imiquimod 5% cream 1 packet (250 mg cream) 3 times per week for 4 weeks
Control, Untreated: No Intervention No treatment of treatment area on the other half of the face and/or balding scalp	Drug: Untreated No treatment of control side

Detailed Description:

Actinic keratoses are common skin lesions associated with excess sun exposure. Over time, there is a small risk a lesion may progress to skin cancer. Since one can not predict which actinic keratosis will progress, the standard of care is to treat the lesions. The most commonly used method to treat actinic keratoses in the United States is with cryotherapy, which uses intense cold to freeze and destroy the lesions. Efficacy appears to be related to how long one freezes the lesion, but increasing the freeze time may result in increased pain and/or skin pigment changes after treatment.

Cryotherapy is a provider-administered "focal" treatment that only treats the lesions that are frozen. There may be early actinic keratoses in the skin surrounding treated lesions that are not easily seen; these may progress over time to visible lesions. There several patient-administered topical treatments for actinic keratoses that are applied to a treatment area or "field" rather than to specific lesions. Imiquimod 5% cream is one such treatment, and is approved in the United States for the treatment of AKs with a dosing regimen of 1 packet applied 2 times per week to a 25 cm2 area 2x/week for 16 weeks.

The study will use a split-face design (one side of face treated and the other side untreated)to explore whether a 4-week course of topical imiquimod 5% cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) in the treatment area at follow-up.

Eligibility

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

Criteria

Inclusion Criteria:

A clinical diagnosis of actinic keratoses
Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp:
- each area with a minimum of 25 cm2 and a maximum of 50 cm2
- each area with at least 6 typical, non-hypertrophic target AKs
- with target AK lesion counts of +/- 1 lesion between the areas
- each area that the patient can distinguish with respect to study drug application
Able to comply with all study requirements
Are willing and able to give written informed consent

Exclusion Criteria:

Uncontrolled intercurrent or chronic illness
Systemic immunocompromise due to disease or treatment
Clinically relevant systemic autoimmune disease
Pregnant or nursing
Dermatologic disease and/or condition in the treatment area that may be exacerbated by imiquimod or cause difficulty with examination
Participation in another clinical study
Allergies to imiquimod or any of the excipients in the cream
Treatment within the past 90 days with any of the following:
- Psoralens plus ultraviolet A therapy
- Ultraviolet B therapy
- Systemic immunomodulators (e.g. oral or parenteral corticosteroids at greater than physiologic doses, interferons, anti-TNF agents, cytokines)
- Chemotherapeutic or cytotoxic agents;
- Investigational agent
Treatment within the past 30 days with any of the following:
- Surgical excision
- Photodynamic therapy
- Curettage
- Topical corticosteroids
- Laser
- Dermabrasion
- Chemical peel
- Imiquimod 5% cream
- Topical retinoids
- 5-fluorouracil
- Masoprocol
- Pimecrolimus or tacrolimus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774787

Locations

United States, Florida
Spencer Dermatology and Skin Surgery	Recruiting
Saint Petersburg, Florida, United States, 33716
Contact: Lynn Allen, RN 727-572-1333
Principal Investigator: James Spencer
United States, Nevada
James Del Rosso	Recruiting
Henderson, Nevada, United States, 89129
Contact: James Del Rosso, DO 702-990-4800
Principal Investigator: James Q Del Rosso
United States, New York
Rigel Dermatology	Not yet recruiting
New York, New York, United States, 10016
Contact: Darrell Rigel, MD 212-684-5964
Principal Investigator: Darrell Rigel, MD

Sponsors and Collaborators

Rigel Dermatology

Graceway Pharmaceuticals, LLC

Investigators

Study Chair:	Darrell S Rigel, MD	Rigel Dermatology
Principal Investigator:	James Q Del Rosso, DO	Private Practice
Principal Investigator:	James Spencer	Spencer Dermatology

More Information

Responsible Party:	Rigell Dermatology ( Darrell S. Rigel )
Study ID Numbers:	08US02IMIQ-Rigel
Study First Received:	October 16, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00774787
Health Authority:	United States: Institutional Review Board

Keywords provided by Rigel Dermatology:

Combination treatment
Imiquimod
Cryotherapy

Study placed in the following topic categories:

Keratosis
Skin Diseases
Facies

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 16, 2009