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A Randomized, Open-label, Assessor-blinded, Split-face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses

Phase 4
18 Years
Not Enrolling
Actinic Keratoses

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Trial Information

A Randomized, Open-label, Assessor-blinded, Split-face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment

Outcome Description:

Percent change = [(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)]/(actinic keratoses count at baseline)]*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.

Outcome Time Frame:

Baseline, 4-8 weeks post-treatment

Safety Issue:


Principal Investigator

Darrell S Rigel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rigel Dermatology


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

March 2010

Related Keywords:

  • Actinic Keratoses
  • Combination treatment
  • Imiquimod
  • Cryotherapy
  • Keratosis
  • Keratosis, Actinic



Spencer Dermatology and Skin SurgerySaint Petersburg, Florida  33716-1115
James Del RossoHenderson, Nevada  89129
Rigel DermatologyNew York, New York  10016