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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-120 Gel | Experimental | IDP-120 Gel, once-daily application |
|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anya Loncaric | Bausch Health Companies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 123 | Mobile | Alabama | 36608 | United States | ||
| Valeant Site 121 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
Not provided
Not provided
Not provided
| 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 |
Not provided
Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
Not provided
Not provided
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 |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Valeant Site 120 | Beverly Hills | California | 90212 | United States |
| Valeant Site 117 | Encinitas | California | 92024 | United States |
| Valeant Site 107 | Fremont | California | 94538 | United States |
| Valeant Site 104 | San Diego | California | 92123 | United States |
| Valeant Site 128 | Denver | Colorado | 80220 | United States |
| Valeant Site 115 | Wheat Ridge | Colorado | 80033 | United States |
| Valeant Site 113 | Clearwater | Florida | 33761 | United States |
| Valeant Site 122 | North Miami Beach | Florida | 33162 | United States |
| Valeant Site 103 | West Palm Beach | Florida | 33401 | United States |
| Valeant Site 101 | Oakbrook Terrace | Illinois | 60181 | United States |
| Valeant Site 124 | Evansville | Indiana | 47715 | United States |
| Valeant Site 111 | Louisville | Kentucky | 40217 | United States |
| Valeant Site 118 | Largo | Maryland | 20774 | United States |
| Valeant Site 129 | Needham | Massachusetts | 20492 | United States |
| Valeant Site 119 | Detroit | Michigan | 48202 | United States |
| Valeant Site 126 | New York | New York | 10076 | United States |
| Valeant Site 108 | High Point | North Carolina | 27262 | United States |
| Valeant Site 106 | Oklahoma City | Oklahoma | 73112 | United States |
| Valeant Site 109 | Austin | Texas | 78759 | United States |
| Valeant Site 130 | Pflugerville | Texas | 78660 | United States |
| Valeant Site 105 | San Antonio | Texas | 78218 | United States |
| Valeant Site 110 | Norfolk | Virginia | 23507 | United States |
| Valeant Site 116 | Walla Walla | Washington | 99362 | United States |
| Valeant Site 112 | Markham | Ontario | L3P 1X2 | Canada |
| Valeant Site 102 | Waterloo | Ontario | N2J 1C4 | Canada |
| Valeant Site 114 | Waterloo | Ontario | N2J 1C4 | Canada |
| Valeant Site 125 | Waterloo | Ontario | N2J 1C4 | Canada |
| Valeant Site 127 | Waterloo | Ontario | N2J 1C4 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| 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 |
|
| 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 |
|
| 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 |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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 |
|
| ||||||||||||||||||||||||||||||||||||||
| 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 |
|
| |||||||||||||||||||||||||||||||||||||
| 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 |
|
| ||||||||||||||||||||||||||||||||||||||
| 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 |
|
| |||||||||||||||||||||||||||||||||||||
| 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 |
|
|
12 weeks
One subject was excluded from the safety population in the IDP-120 Gel group, due to not applying any study medication.
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 | IDP-120 Gel | IDP-120 Gel, once daily application | 0 | 305 | 1 | 305 | 27 | 305 |
| EG001 | IDP-120 Vehicle Gel | IDP-120 Vehicle Gel, once daily application | 0 | 300 | 0 | 300 | 3 | 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|