Status:
COMPLETED
Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
Lead Sponsor:
Rigel Dermatology
Conditions:
Actinic Keratoses
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00774787
Start Date
October 1 2008
End Date
March 1 2010
Last Update
November 7 2016
Active Locations (3)
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1
Spencer Dermatology and Skin Surgery
St. Petersburg, Florida, United States, 33716
2
James Del Rosso
Henderson, Nevada, United States, 89129
3
Rigel Dermatology
New York, New York, United States, 10016