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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774787
Recruitment Status : Completed
First Posted : October 17, 2008
Results First Posted : October 27, 2010
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):
Darrell S. Rigel, Rigel Dermatology

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 follow-up.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: imiquimod 5% cream Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Assessor-blinded, Split-face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses
Study Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Imiquimod, treatment, topical cream
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
Other Name: Aldara
No Intervention: Control, Untreated
No treatment of treatment area on the other half of the face and/or balding scalp

Primary Outcome Measures :
  1. Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment [ Time Frame: Baseline, 4-8 weeks post-treatment ]
    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.

Secondary Outcome Measures :
  1. Cosmetic Appearance Score at 4-8 Weeks Post-treatment [ Time Frame: 4-8 weeks post-treatment ]
    Cosmetic appearance score, based recall comparison to appearance at baseline. Seven point scale: +3 = treatment area is much better appearing; +2 = treatment area is moderately better appearing; + 1 = treatment area is slightly better appearing; 0 = treatment area appears same; -1 = treatment area is slightly worse appearing; -2 = treatment area is moderately worse appearing; -3 = treatment area is much worse appearing. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.

Other Outcome Measures:
  1. Local Skin Reactions [ Time Frame: Post baseline to end of study (4-8 weeks post-treatment) ]
    Mean maximum post-baseline intensity of investigator assessed local skin reactions (erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, erosion/ulceration) by treatment area. 0 = none, 1 = mild, 2 = moderate, 3 = severe. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774787

United States, Florida
Spencer Dermatology and Skin Surgery
Saint Petersburg, Florida, United States, 33716
United States, Nevada
James Del Rosso
Henderson, Nevada, United States, 89129
United States, New York
Rigel Dermatology
New York, New York, United States, 10016
Sponsors and Collaborators
Rigel Dermatology
Study Chair: Darrell S Rigel, MD Rigel Dermatology
Principal Investigator: James Q Del Rosso, DO Private Practice
Principal Investigator: James Spencer Spencer Dermatology

Responsible Party: Darrell S. Rigel, PI, Rigel Dermatology Identifier: NCT00774787     History of Changes
Other Study ID Numbers: 08US02IMIQ-Rigel
First Posted: October 17, 2008    Key Record Dates
Results First Posted: October 27, 2010
Last Update Posted: November 7, 2016
Last Verified: October 2016

Keywords provided by Darrell S. Rigel, Rigel Dermatology:
Combination treatment

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers