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This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-123 Lotion | Experimental | Tazarotene 0.045% Lotion |
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| IDP-123 Vehicle Lotion | Placebo Comparator | Vehicle Lotion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-123 Lotion | Drug | Tazarotene 0.045% Lotion |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Mean Lesion Counts at Week 12 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. | Baseline to Week 12 |
| Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear" | Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Mean Lesion Counts at Week 12 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anya Loncaric | Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 41 | Mobile | Alabama | 36608 | United States | ||
| Valeant Site 22 |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDP-123 Lotion | IDP-123 (Tazarotene 0.045%) Lotion |
| FG001 | Vehicle Lotion | IDP-123 Vehicle Lotion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2017 |
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| IDP-123 Vehicle Lotion | Drug | Vehicle Lotion |
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| Baseline to Week 12 |
| Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) | Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe. | Baseline to Week 12 |
| Percentage Change in Mean Lesion Counts at Week 8 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. | Baseline to Week 8 |
| Percentage Change in Mean Lesion Counts at Week 4 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. | Baseline to Week 4 |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Valeant Site 34 | Carlsbad | California | 92008 | United States |
| Valeant Site 12 | Fremont | California | 94538 | United States |
| Valeant Site 06 | San Diego | California | 92123 | United States |
| Valeant Site 13 | San Diego | California | 92123 | United States |
| Valeant Site 31 | San Diego | California | 92123 | United States |
| Valeant Site 36 | Santa Ana | California | 92701 | United States |
| Valeant Site 25 | Denver | Colorado | 80220 | United States |
| Valeant Site 05 | Boynton Beach | Florida | 33437 | United States |
| Valeant Site 29 | Clearwater | Florida | 33761 | United States |
| Valeant Site 38 | Jupiter | Florida | 33458 | United States |
| Valeant Site 02 | Miami | Florida | 33144 | United States |
| Valeant Site 26 | West Palm Beach | Florida | 33406 | United States |
| Valeant Site 44 | Snellville | Georgia | 30078 | United States |
| Valeant Site 32 | Louisville | Kentucky | 40241 | United States |
| Valeant Site 19 | Rockville | Maryland | 20850 | United States |
| Valeant Site 08 | Bay City | Michigan | 48706 | United States |
| Valeant Site 30 | Clarkston | Michigan | 48346 | United States |
| Valeant Site 37 | Clinton Township | Michigan | 48038 | United States |
| Valeant Site 20 | Fort Gratiot | Michigan | 48059 | United States |
| Valeant Site 24 | Fridley | Minnesota | 55432 | United States |
| Valeant Site 03 | Morristown | New Jersey | 07960 | United States |
| Valeant Site 42 | Albuquerque | New Mexico | 87106 | United States |
| Valeant Site 10 | New York | New York | 10155 | United States |
| Valeant Site 43 | Rochester | New York | 14623 | United States |
| Valeant Site 33 | Stony Brook | New York | 11790 | United States |
| Valeant Site 11 | Oklahoma City | Oklahoma | 73112 | United States |
| Valeant Site 28 | Broomall | Pennsylvania | 19008 | United States |
| Valeant Site 16 | Warwick | Rhode Island | 02886 | United States |
| Valeant Site 18 | Knoxville | Tennessee | 37922 | United States |
| Valeant Site 14 | Murfreesboro | Tennessee | 37130 | United States |
| Valeant Site 23 | College Station | Texas | 77845 | United States |
| Valeant Site 07 | Dallas | Texas | 75234 | United States |
| Valeant Site 27 | Pflugerville | Texas | 78660 | United States |
| Valeant Site 04 | San Antonio | Texas | 78218 | United States |
| Valeant Site 39 | Sugar Land | Texas | 77479 | United States |
| Valeant Site 09 | Layton | Utah | 84041 | United States |
| Valeant Site 15 | West Jordan | Utah | 84088 | United States |
| Valeant Site 21 | Charlottesville | Virginia | 22911 | United States |
| Valeant Site 35 | Walla Walla | Washington | 99362 | United States |
| Valeant Site 01 | Surrey | British Columbia | V3VOC6 | Canada |
| Valeant Site 45 | Winnipeg | Manitoba | R3M3Z4 | Canada |
| Valeant Site 40 | Windsor | Ontario | N8W5L7 | Canada |
| Valeant Site 17 | Saint-Jérôme | Quebec | J7Z3B8 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IDP-123 Lotion | IDP-123 (Tazarotene 0.045%) Lotion |
| BG001 | Vehicle Lotion | IDP-123 Vehicle Lotion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Lesion counts | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. | Mean | Standard Deviation | lesions |
| ||||||||||||||
| Evaluator's Global Severity Score | Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe. | Count of Participants | Participants |
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| 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 | Absolute Change in Mean Lesion Counts at Week 12 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. | Posted | Least Squares Mean | Standard Deviation | lesion counts | Baseline to Week 12 |
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| Primary | Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear" | Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe. | Posted | Number | percentage of participants | Baseline to Week 12 |
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| Secondary | Percentage Change in Mean Lesion Counts at Week 12 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. | Posted | Least Squares Mean | Standard Deviation | percentage change | Baseline to Week 12 |
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| Secondary | Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) | Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe. | Posted | Number | percentage of participants | Baseline to Week 12 |
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| Secondary | Percentage Change in Mean Lesion Counts at Week 8 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. | Posted | Least Squares Mean | Standard Deviation | percentage change | Baseline to Week 8 |
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| Secondary | Percentage Change in Mean Lesion Counts at Week 4 | For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately. | Posted | Least Squares Mean | Standard Deviation | percentage change | Baseline to Week 4 |
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12 weeks
Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment. There were 10 participants in the IDP-123 Lotion and 12 participants in the IDP-123 Vehicle Lotion group who did not have any post- baseline safety assessment.
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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 | IDP-123 Lotion | IDP-123 (Tazarotene 0.045%) Lotion | 0 | 387 | 1 | 387 | 43 | 387 |
| EG001 | Vehicle Lotion | IDP-123 Vehicle Lotion | 0 | 392 | 1 | 392 | 17 | 392 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion induced | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Pain | General disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
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Please contact Sponsor directly for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health Americas, Inc | 510-259-5284 | aloncaric@bauschhealth.com |
| Feb 15, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Inflammatory lesions |
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| Severe |
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