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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imiquimod, treatment, topical cream | Experimental | Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp |
|
| Control, Untreated | No Intervention | No treatment of treatment area on the other half of the face and/or balding scalp |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imiquimod 5% cream | Drug | 1 packet (250 mg cream) 3 times per week for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4-8 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Skin Reactions | 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. | Post baseline to end of study (4-8 weeks post-treatment) |
Inclusion Criteria:
A clinical diagnosis of actinic keratoses
Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp:
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:
Treatment within the past 30 days with any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Darrell S Rigel, MD | Rigel Dermatology | Study Chair |
| James Q Del Rosso, DO | Private Practice | Principal Investigator |
| James Spencer | Spencer Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spencer Dermatology and Skin Surgery | St. Petersburg | Florida | 33716 | United States | ||
| James Del Rosso |
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First patient enrolled - 08 Oct 08; last patient enrolled - 07 Jul 09; last patient completed: 09 Sep 09; Setting - private practice clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Cryotherapy Followed by Imiquimod 5% Cream or Observation | Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cryotherapy Followed by Imiquimod 5% Cream or Observation | Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients who had end of study visit with count of actinic keratoses. Change not calculated for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline or new. | Posted | Mean | Standard Deviation | Percent change | Baseline, 4-8 weeks post-treatment |
|
8-12 weeks: from baseline cryotherapy visit to end of study (4-8 weeks post completion of imiquimod treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cryotherapy Followed by Imiquimod 5% Cream or Observation | Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Systemic interferon reaction on areas with previous sun exposure; arms, thighs, upper chest, upper b | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Open label; small patient number; planned secondary endpoint of change in only lesions treated with cryotherapy (baseline) not determinable as only all lesions (baseline + new) consistently captured.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darrell Rigel | Rigel Dermatology | 212-684-5964 | dsrigel@prodigy.net |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 4-8 weeks post-treatment |
| Henderson |
| Nevada |
| 89129 |
| United States |
| Rigel Dermatology | New York | New York | 10016 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Actinic keratoses, total | Total count of clinically diagnosed actinic keratoses in target treatment area | Mean | Standard Deviation | Lesions |
|
| Actinic keratoses, Imiquimod side | Count of actinic keratoses on side of target treatment area randomly assigned to imiquimod 5% cream following cryotherapy | Mean | Standard Deviation | Lesions |
|
| Actinic keratoses, Observation Side | Count of actinic keratoses on side of target treatment area randomly assigned to observation following cryotherapy | Mean | Standard Deviation | Lesions |
|
Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment |
|
|
| Post-Hoc | Complete Clearance of Actinic Keratoses at 4-8 Weeks Post-treatment | Complete clearance (actinic keratosis count of 0) in each respective area at 4-8 weeks post-treatment. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new. | All patients enrolled. | Posted | Number | Participants | 4-8 weeks post-treatment | Treatment areas | Participants |
|
|
|
| Secondary | 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. | Patients who had end of study visit with cosmetic appearance assessment. Cosmetic appearance score, by treatment area, not included for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data. | Posted | Mean | Standard Deviation | Scores on a scale | 4-8 weeks post-treatment |
|
|
|
| Other Pre-specified | Local Skin Reactions | 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. | One patient not included who was lost to follow-up immediately after baseline visit, and had no post-treatment data. | Posted | Mean | Standard Deviation | Scores on a scale | Post baseline to end of study (4-8 weeks post-treatment) |
|
|
|
| 0 |
| 27 |
| 3 |
| 27 |
|
| Weakness | General disorders | Non-systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cold | Infections and infestations | Non-systematic Assessment |
|
PIs must agree on communication of complete results, but may discuss individual site results. Collaborator can review complete results communications prior to public release and can embargo communications regarding trial results, if patents are to be pursued, for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the collaborator for review. The collaborator cannot require changes to the communication and cannot extend the embargo.
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 | Heterocyclic Compounds |
|
| Patient assessed, observation side |
|
| Title | Measurements |
|---|---|
|
| Edema, observation side |
|
| Weeping/exudate, imiquimod side |
|
| Weeping/exudate, observation side |
|
| Flaking/scaling/dryness, imiquimod side |
|
| Flaking/scaling/dryness, observation side |
|
| Scabbing/crusting, imiquimod side |
|
| Scabbing/crusting, observation side |
|
| Erosion/ulceration, imiquimod side |
|
| Erosion/ulceration, observation side |
|