Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.
This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States.
This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aldara 5% | Experimental | Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imiquimod cream | Drug | imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment. | from first dose up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count | Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count | At Month 18 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sharon Levy, MD | Graceway Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85044 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20729935 | Result | Del Rosso JQ, Sofen H, Leshin B, Meng T, Kulp J, Levy S. Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses. J Clin Aesthet Dermatol. 2009 Apr;2(4):20-8. |
Not provided
Not provided
Open-label study - subjects were required to be at least 18 years of age and to have greater than 25 centimeters squared total treatment area(s) containing at least 4 clinically typical, visible, discrete, nonhypertrophic Actinic Keratosis lesions without any dermatological disease and/or condition in the treatment or surrounding area.
Study start - 14 July 2005 at 31 study centers 500 subjects were planned, with up to 15 subjects enrolled at each study center; however, some study centers were unable to enroll 15 subjects, so active centers were asked to enroll additional subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aldara (Imiquimod) Cream | Aldara (imiquimod) Cream 5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Encino |
| California |
| 91436 |
| United States |
| Los Angeles | California | 90045 | United States |
| Riverside | California | 92506 | United States |
| San Diego | California | 92117 | United States |
| Santa Monica | California | 90404 | United States |
| Denver | Colorado | 80210 | United States |
| New Britain | Connecticut | 06052 | United States |
| Coral Gables | Florida | 33134 | United States |
| Hollywood | Florida | 33021 | United States |
| Miami | Florida | 33175 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Arlington Heights | Illinois | 60005 | United States |
| Indianapolis | Indiana | 46256 | United States |
| Metairie | Louisiana | 70006 | United States |
| Boston | Massachusetts | 02118 | United States |
| Chaska | Minnesota | 55318 | United States |
| Henderson | Nevada | 89014 | United States |
| Henderson | Nevada | 89052 | United States |
| Reno | Nevada | 89509 | United States |
| Reno | Nevada | 89521 | United States |
| New York | New York | 10021 | United States |
| High Point | North Carolina | 27262 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Winston-Salem | North Carolina | 27106 | United States |
| Portland | Oregon | 97210 | United States |
| Flourtown | Pennsylvania | 19031 | United States |
| Arlington | Texas | 76011 | United States |
| San Antonio | Texas | 78229 | United States |
| Woodbridge | Virginia | 22191 | United States |
| Spokane | Washington | 99204 | United States |
| Milwaukee | Wisconsin | 53207 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aldara (Imiquimod) Cream | Aldara (imiquimod) Cream 5% |
| 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 |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Baseline actinic keratosis lesion count | Mean | Standard Deviation | actinic keratosis lesions |
|
| 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 Who Experienced an Adverse Event | Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment. | There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication. | Posted | Number | participants | from first dose up to 18 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count | Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count | The ITT population (n=526) consisted of the Safety population who had at least one scheduled primary efficacy assessment at a post-baseline visit | Posted | Mean | Standard Deviation | percent reduction | At Month 18 |
|
|
Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence.
Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aldara (Imiquimod) Cream | Aldara (imiquimod) Cream 5% | 39 | 551 | 472 | 551 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Intrervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Intervertebral disk protrusion | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Actinic Keratosis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Seborrhoeic Keratosis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Skin Papilloma | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Levy, MD VP Product Development | Graceway Pharmaceuticals LLC | 267-948-0500 | sharon.levy@gracewaypharma.com |
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|