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study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12. 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-120 Gel | Experimental | IDP-120 Gel, once-daily application |
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| IDP-120 vehicle gel | Placebo Comparator | IDP-120 vehicle gel, once daily application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-120 Gel | Drug | IDP-120 Gel, once-daily application |
| |
| IDP-120 Vehicle Gel |
| 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 | Bausch Health Companies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 210 | Rogers | Arkansas | 72758 | United States | ||
| Valeant Site 201 |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDP-120 Gel | IDP-120 Gel, once-daily application |
| FG001 | IDP-120 Vehicle Gel | IDP-120 Vehicle Gel, once-daily application |
| 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 29, 2019 |
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Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
| Drug |
IDP-120 Vehicle Gel, once-daily application |
|
| 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 |
| Manhattan Beach |
| California |
| 90266 |
| United States |
| Valeant Site 206 | San Diego | California | 92123 | United States |
| Valeant Site 218 | San Diego | California | 92123 | United States |
| Valeant Site 204 | Boynton Beach | Florida | 33437 | United States |
| Valeant Site 217 | Brandon | Florida | 33511 | United States |
| Valeant Site 202S | Miami | Florida | 33144 | United States |
| Valeant Site 214 | Tampa | Florida | 33606 | United States |
| Valeant Site 222 | Snellville | Georgia | 30078 | United States |
| Valeant Site 215 | Boise | Idaho | 83704 | United States |
| Valeant Site 205 | Metairie | Louisiana | 70006 | United States |
| Valeant Site 216 | Clarkston | Michigan | 48346 | United States |
| Valeant Site 221 | Clinton Township | Michigan | 48038 | United States |
| Valeant Site 227 | Rochester | New York | 14623 | United States |
| Valeant Site 229 | Raleigh | North Carolina | 27612 | United States |
| Valeant Site 230 | Raleigh | North Carolina | 27612 | United States |
| Valeant Site 213 | San Antonio | Texas | 78213 | United States |
| Valeant Site 223 | Spokane | Washington | 99202 | United States |
| Valeant Site 219 | Waterloo | Ontario | N2J 1C4 | Canada |
| Valeant Site 228 | Waterloo | Ontario | N2J 1C4 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IDP-120 Gel | IDP-120 Gel, once-daily application |
| BG001 | IDP-120 Vehicle Gel | IDP-120 Vehicle Gel, once-daily application |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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
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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-120 Gel | IDP-120 Gel, once-daily application | 0 | 293 | 1 | 293 | 53 | 293 |
| EG001 | IDP-120 Vehicle Gel | IDP-120 Vehicle Gel, once-daily application | 0 | 292 | 2 | 292 | 8 | 292 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion induced | Surgical and medical procedures | MedDRA 22.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Application site dryness | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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Contact sponsor for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health Americas, Inc | 19083009920 | susan.harris@bauschhealth.com |
| Mar 3, 2023 |
| Prot_SAP_000.pdf |
| 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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