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

This study has been completed.
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by:
Rigel Dermatology
ClinicalTrials.gov Identifier:
NCT00774787
First received: October 16, 2008
Last updated: November 1, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Actinic Keratoses
 Drug: imiquimod 5% cream
Drug: Untreated
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

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

Further study details as provided by Rigel Dermatology:

Primary Outcome Measures:
  • Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment [ Time Frame: Baseline, 4-8 weeks post-treatment ] [ Designated as safety issue: No ]
    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:
  • Cosmetic Appearance Score at 4-8 Weeks Post-treatment [ Time Frame: 4-8 weeks post-treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Untreated
No treatment of control side

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774787

Locations
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
Graceway Pharmaceuticals, LLC
Investigators
Study Chair: Darrell S Rigel, MD Rigel Dermatology
Principal Investigator: James Q Del Rosso, DO Private Practice
Principal Investigator: James Spencer Spencer Dermatology
  More Information

No publications provided

Responsible Party: Darrell S. Rigel, Rigell Dermatology
ClinicalTrials.gov Identifier: NCT00774787     History of Changes
Other Study ID Numbers: 08US02IMIQ-Rigel
Study First Received: October 16, 2008
Results First Received: September 30, 2010
Last Updated: November 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Rigel Dermatology:
Combination treatment
Imiquimod
Cryotherapy

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on May 23, 2013