Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses

Completed · Phase 4

Conditions studied: Actinic Keratoses

In brief

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.

Key facts

Study ID

NCT00774787

Run by

Rigel Dermatology

People needed

27

Starts

2008-10-01

Expected to finish

2010-03-01

Last updated by the study team

2016-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 cm\^2 and a maximum of 50 cm\^2
• 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

You may not qualify if…

• 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

Where it is running

• Spencer Dermatology and Skin Surgery — St. Petersburg, Florida, United States
• James Del Rosso — Henderson, Nevada, United States
• Rigel Dermatology — New York, New York, United States

Full record on ClinicalTrials.gov

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