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

Primary Purpose

Actinic Keratoses

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
imiquimod 5% cream
Sponsored by
Rigel Dermatology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses focused on measuring Combination treatment, Imiquimod, Cryotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Spencer Dermatology and Skin Surgery
  • James Del Rosso
  • Rigel Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Imiquimod, treatment, topical cream

Control, Untreated

Arm Description

Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp

No treatment of treatment area on the other half of the face and/or balding scalp

Outcomes

Primary Outcome Measures

Change From Baseline in Actinic Keratoses Count at 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

Cosmetic Appearance Score at 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.

Full Information

First Posted
October 16, 2008
Last Updated
October 3, 2016
Sponsor
Rigel Dermatology
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1. Study Identification

Unique Protocol Identification Number
NCT00774787
Brief Title
Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
Official Title
A Randomized, Open-label, Assessor-blinded, Split-face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigel Dermatology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
Keywords
Combination treatment, Imiquimod, Cryotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imiquimod, treatment, topical cream
Arm Type
Experimental
Arm Description
Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp
Arm Title
Control, Untreated
Arm Type
No Intervention
Arm Description
No treatment of treatment area on the other half of the face and/or balding scalp
Intervention Type
Drug
Intervention Name(s)
imiquimod 5% cream
Other Intervention Name(s)
Aldara
Intervention Description
1 packet (250 mg cream) 3 times per week for 4 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment
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.
Time Frame
Baseline, 4-8 weeks post-treatment
Secondary Outcome Measure Information:
Title
Cosmetic Appearance Score at 4-8 Weeks Post-treatment
Description
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.
Time Frame
4-8 weeks post-treatment
Other Pre-specified Outcome Measures:
Title
Local Skin Reactions
Description
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.
Time Frame
Post baseline to end of study (4-8 weeks post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrell S Rigel, MD
Organizational Affiliation
Rigel Dermatology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James Q Del Rosso, DO
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Spencer
Organizational Affiliation
Spencer Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spencer Dermatology and Skin Surgery
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
James Del Rosso
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
Rigel Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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

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