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The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp.
Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has shown to be safe and effective for the treatment of AKs.
These were a randomized, double-blind, multicenter, placebo-controlled studies that compared the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo in the treatment of typical visible or palpable AK of the face or balding scalp. Subjects were scheduled for a total of 11 visits (1 prestudy screening visit and 10 on-study visits). Subjects determined to be eligible during the screening phase were randomized in a 1:1:1 ratio to 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream. The creams were applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. The investigator selected the treatment area for the study (either the entire face or the entire balding scalp, but not both). Subjects applied a thin layer of cream to the treatment area (up to 2 packets, or 500 mg of product, per application), avoiding the periocular areas, lips, and nares. Study medication was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. Ears were excluded from both assessment and treatment. Rest periods from daily treatment were instituted by the investigator as needed to manage local skin reactions (LSRs) or application site reactions, with resumption of treatment upon adequate resolution as determined by the investigator.
The duration of each subject's study participation was approximately 21 weeks, including a 4-week maximum screening period and a 17-week study period. At the End of Study (EOS) visit, eligible subjects may have been invited to participate in a separate study evaluating AK recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.75% imiquimod cream | Active Comparator |
| |
| 2.5% imiquimod cream | Active Comparator |
| |
| Placebo cream | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod cream | Drug | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Clearance of AK Lesions | Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or "subclinical" lesion that had not been identified at Baseline. | End of Study the Week 17 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Partial Clearance of AK Lesions | Subject status with respect to complete clearance of AK lesions at End of Study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline. | End of Study the Week 17 visit |
| Percent Change From Baseline in AK Lesion Count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon F Levy, MD | Graceway Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20133012 | Background | Hanke CW, Beer KR, Stockfleth E, Wu J, Rosen T, Levy S. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 3-week cycles. J Am Acad Dermatol. 2010 Apr;62(4):573-81. doi: 10.1016/j.jaad.2009.06.020. Epub 2010 Feb 4. |
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Subjects were screened and had to meet eligibility requirements for randomization. The most frequent reason for screen failure (44 of screen failures) was that the subject did not have between 5 and 20 visible or palpable lesions on either the face or the balding scalp.
Recruitment started on January 15, 2008 and all subjects were randomized by March 6, 2008. The studies were performed at 26 investigational centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3.75% Imiquimod Cream | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo cream | Drug | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
|
| Imiquimod cream | Drug | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
|
Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions. A negative percent change is better than a positive percent change. |
| At all visits - Baseline through the Week 17 EOS visit |
| Local Skin Reactions (LSR) | Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each visit. These included: Erythema, edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Summary of LSR - area under the curve (AUC) of sum of LSR scores (days). | The time period for the AUC extends to 8 weeks after the end of treatment (Week 17) |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Encino | California | 91436 | United States |
| Vista | California | 92083 | United States |
| New Britain | Connecticut | 06052 | United States |
| New Haven | Connecticut | 06511 | United States |
| Coral Gables | Florida | 33134 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Arlington Heights | Illinois | 60005 | United States |
| Champaign | Illinois | 61820 | United States |
| Carmel | Indiana | 46032 | United States |
| Evansville | Indiana | 47713 | United States |
| South Bend | Indiana | 46617 | United States |
| Louisville | Kentucky | 40202 | United States |
| Omaha | Nebraska | 68144 | United States |
| Reno | Nevada | 89509 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Portland | Oregon | 97223 | United States |
| Philadelphia | Pennsylvania | 19034 | United States |
| Nashville | Tennessee | 37203 | United States |
| Dallas | Texas | 75246 | United States |
| Houston | Texas | 77030 | United States |
| Houston | Texas | 77058 | United States |
| San Antonio | Texas | 78229 | United States |
| Norfolk | Virginia | 23507 | United States |
| Woodbridge | Virginia | 22191 | United States |
| 2.5% Imiquimod Cream |
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
| FG002 | Placebo Cream | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 3.75% Imiquimod Cream | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
| BG001 | 2.5% Imiquimod Cream | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
| BG002 | Placebo Cream | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Participants With Complete Clearance of AK Lesions | Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or "subclinical" lesion that had not been identified at Baseline. | Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF), primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis). | Posted | Number | participants | End of Study the Week 17 visit |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Partial Clearance of AK Lesions | Subject status with respect to complete clearance of AK lesions at End of Study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline. | Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF). | Posted | Number | participants | End of Study the Week 17 visit |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in AK Lesion Count | Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions. A negative percent change is better than a positive percent change. | Intent to treat (ITT) population using last observation carried forward (LOCF). | Posted | Median | Full Range | percentage of participants | At all visits - Baseline through the Week 17 EOS visit |
| |||||||||||||||||||||||||||||||||
| Secondary | Local Skin Reactions (LSR) | Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each visit. These included: Erythema, edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Summary of LSR - area under the curve (AUC) of sum of LSR scores (days). | All participants were evaluated for local skin reactions (LSR) at every visit. The ITT population was used. Only subjects who received treatment in both cycles are included in the analysis. | Posted | Mean | Standard Deviation | units on a scale * days | The time period for the AUC extends to 8 weeks after the end of treatment (Week 17) |
|
From study screening through the last study visit. From Day 1 up to Week 17
Subjects were queried indirectly regarding AEs during each study visit.
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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 | 3.75% Imiquimod Cream | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. | 10 | 162 | 39 | 162 | ||
| EG001 | 2.5% Imiquimod Cream | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. | 5 | 164 | 29 | 164 | ||
| EG002 | Placebo Cream | 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. | 3 | 164 | 2 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 11.0 | Non-systematic Assessment |
| |
| Surgery | Surgical and medical procedures | MedDRA (11.0) | Non-systematic Assessment | Surgery to replace bladder band |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritus | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon F Levy, MD | Graceway Pharmaceuticals | 267-948-0400 | sharon.levy@gracewaypharma.com |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D017437 | Skin and Connective Tissue Diseases |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
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| OG002 |
| Placebo Cream |
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. |
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