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

Rigel Dermatology

Status and phase

Completed

Phase 4

Conditions

Actinic Keratoses

Treatments

Drug: imiquimod 5% cream

Study type

Interventional

Funder types

Other

Identifiers

NCT00774787

08US02IMIQ-Rigel

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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 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