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The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK.
The secondary objective is to compare the adverse event (AE) profiles of the two creams.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imiquimod 5% Taro | Experimental | Imiquimod 5% manufactured by Taro applied for 16 weeks |
|
| Aldara - Imiquimod 5% | Active Comparator | Aldara, Imiquimod 5% applied for 16 weeks |
|
| Vehicle | Placebo Comparator | Imiquimod vehicle applied for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod 5% manufactured by Taro | Drug | Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5% | Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions. | 24 weeks |
| Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline | Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Reporting at Least One Adverse Event | For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Gilbert | Arizona | United States | |||
| Investigator Site |
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Patients were recruited at 20 dermatology clinical practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imiquimod 5% Taro | Imiquimod 5% manufactured by Taro applied for 16 weeks |
| FG001 | Aldara - Imiquimod 5% | Aldara, Imiquimod 5% applied for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized |
|
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| Aldara - Imiquimod 5% | Drug | Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks |
|
| Imiquimod Vehicle manufactured by Taro | Drug | Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks |
|
| Tempe |
| Arizona |
| United States |
| Investigator Site | Tuscon | Arizona | United States |
| Investigator Site | Denver | Colorado | United States |
| Investigator Site | Jacksonville | Florida | United States |
| Investigator Site | Miami | Florida | United States |
| Investigator Site | Evansvill | Indiana | United States |
| Investigator Site | Plainfield | Indiana | United States |
| Investigator Site | Olathe | Kansas | United States |
| Investigator Site | Wichita | Kansas | United States |
| Investigator Site | Omaha | Nebraska | United States |
| Investigator Site | Henderson | Nevada | United States |
| Investigator Site | Cary | North Carolina | United States |
| Investigator Site | Hickory | North Carolina | United States |
| Investigator Site | High Point | North Carolina | United States |
| Investigator Site | Winston-Salem | North Carolina | United States |
| Investigator Site | Simpsonville | South Carolina | United States |
| Investigator Site | Murfreesboro | Tennessee | United States |
| Investigator Site | College Station | Texas | United States |
| Investigator Site | Tyler | Texas | United States |
| FG002 | Vehicle | Patients receiving imiquimod Vehicle for 16 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| Treated - Received at Least One Dose |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Imiquimod 5% Taro | Imiquimod 5% manufactured by Taro applied for 16 weeks |
| BG001 | Aldara - Imiquimod 5% | Aldara, Imiquimod 5% applied for 16 weeks |
| BG002 | Vehicle | Patients receiving imiquimod Vehicle for 16 weeks |
| 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 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5% | Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions. | Per Protocol (PP) population | Posted | Number | Participants | 24 weeks |
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| Secondary | Patients Reporting at Least One Adverse Event | For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event. | Safety group includes all patients who received a single dose | Posted | Number | Participants | 24 weeks |
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| Primary | Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline | Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions. | Intention to Treat (ITT) Population | Posted | Number | Participants | 24 weeks |
|
Assessed at 24 weeks
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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 | Imiquimod 5% Taro | Imiquimod 5% manufactured by Taro applied for 16 weeks | 4 | 183 | 22 | 183 | ||
| EG001 | Aldara - Imiquimod 5% | Aldara, Imiquimod 5% applied for 16 weeks | 6 | 179 | 22 | 179 | ||
| EG002 | Vehicle | Patients receiving imiquimod Vehicle for 16 weeks | 1 | 60 | 4 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (11.1) |
| ||
| HYPOTENSION | Vascular disorders | MedDRA (11.1) |
| ||
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (11.1) |
| ||
| LOBAR PNEUMONIA | Infections and infestations | MedDRA (11.1) |
| ||
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (11.1) |
| ||
| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA (11.1) |
| ||
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (11.1) |
| ||
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (11.1) |
| ||
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (11.1) |
| ||
| SYNCOPE | Nervous system disorders | MedDRA (11.1) |
| ||
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
| ||
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APPLICATION SITE ERYTHEMA | General disorders | MedDRA (11.1) |
| ||
| APPLICATION SITE IRRITATION | General disorders | MedDRA (11.1) |
| ||
| APPLICATION SITE PRURITUS | General disorders | MedDRA (11.1) |
| ||
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Taro Pharmaceuticals USA | (914) 345-9001 | 6427 | medical.affairs@taro.com |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue 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 |
| D006571 | Heterocyclic Compounds |
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| Lost to Follow-up |
|
| Protocol Violation |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
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| Units | Counts |
|---|---|
| Participants |
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