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The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-121 Lotion | Experimental | IDP-121 lotion (tretinoin 0.05 percent [%]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
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| IDP-121 Vehicle Lotion | Placebo Comparator | IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-121 Lotion | Drug | IDP-121 lotion will be applied as per the instructions provided by the investigational center staff. |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count. | Baseline (Day 0), Week 12 |
| Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately. | Baseline, Week 12 |
| Percentage of Participants With Treatment Success at Week 12 | Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Noninflammatory Lesion Count to Week 12 | Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Theisen | TKL Research, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 36 | Guntersville | Alabama | 35976 | United States | ||
| Valeant Site 14 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32886337 | Derived | Tyring SK, Kircik L, Pariser DM, Woolery-Lloyd HC, Harper JC, Bhatt V, Pillai R, Guenin E. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol. 2020 Dec;21(6):891-899. doi: 10.1007/s40257-020-00559-3. |
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Participants were randomized in a 1:1 ratio to receive either IDP-121(tretinoin 0.05 percent [%]) Lotion or IDP-121 Vehicle Lotion.
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| ID | Title | Description |
|---|---|---|
| FG000 | IDP-121 Lotion | IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
| FG001 | IDP-121 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 | Oct 7, 2016 |
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| IDP-121 Vehicle Lotion | Drug | IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff. |
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| Baseline, Week 12 |
| Percent Change From Baseline in Inflammatory Lesion Count to Week 12 | Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately. | Baseline, Week 12 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Valeant Site 28 | Hot Springs | Arkansas | 71913 | United States |
| Valeant Site 38 | Fountain Valley | California | 92708 | United States |
| Valeant Site 34 | Manhattan Beach | California | 90266 | United States |
| Valeant Site 23 | Oceanside | California | 92056 | United States |
| Valeant Site 35 | Rancho Cucamonga | California | 91730 | United States |
| Valeant Site 20 | San Diego | California | 92123 | United States |
| Valeant Site 32 | Denver | Colorado | 80220 | United States |
| Valeant Site 10 | Shelton | Connecticut | 06484 | United States |
| Valeant Site 02 | Boynton Beach | Florida | 33437 | United States |
| Valeant Site 15 | Coral Gables | Florida | 33146 | United States |
| Valeant Site 37 | Miami | Florida | 33142 | United States |
| Valeant Site 39 | Pembroke Pines | Florida | 33028 | United States |
| Valeant Site 01 | West Palm Beach | Florida | 33401 | United States |
| Valeant Site 19 | Boise | Idaho | 83704 | United States |
| Valeant Site 04 | Arlington Heights | Illinois | 60005 | United States |
| Valeant Site 27 | Carmel | Indiana | 46032 | United States |
| Valeant 12 | Plainfield | Indiana | 46168 | United States |
| Valeant Site 09 | Louisville | Kentucky | 40202 | United States |
| Valeant Site 16 | Louisville | Kentucky | 40217 | United States |
| Valeant Site 33 | Needham | Massachusetts | 02492 | United States |
| Valeant Site 11 | Warren | Michigan | 48088 | United States |
| Valeant Site 08 | Omaha | Nebraska | 68114 | United States |
| Valeant Site 25 | Omaha | Nebraska | 68144 | United States |
| Valeant Site 13 | Berlin | New Jersey | 08009 | United States |
| Valeant Site 03 | Albuquerque | New Mexico | 87106 | United States |
| Valeant Site 26 | New York | New York | 10022 | United States |
| Valeant Site 31 | Stony Brook | New York | 11790 | United States |
| Valeant 05 | Gresham | Oregon | 97030 | United States |
| Valeant Site 22 | Fort Washington | Pennsylvania | 19034 | United States |
| Valeant Site 24 | Charleston | South Carolina | 29414 | United States |
| Valeant Site 06 | Dallas | Texas | 75231 | United States |
| Valeant Site 30 | Houston | Texas | 77004 | United States |
| Valeant Site 17 | Pflugerville | Texas | 78660 | United States |
| Valeant Site 07 | San Antonio | Texas | 78229 | United States |
| Valeant 18 | Webster | Texas | 77598 | United States |
| Valeant Site 29 | Salt Lake City | Utah | 84117 | United States |
| Valeant Site 21 | Norfolk | Virginia | 23502 | United States |
IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
| Intent-to-treat (ITT) Population | All randomized participants who received study drug. |
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| Safety Population | All randomized participants with ≥1 confirmed dose of study drug and ≥1 post baseline evaluation. |
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| COMPLETED |
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| NOT COMPLETED |
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ITT analysis set included all randomized participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | IDP-121 Lotion | IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
| BG001 | IDP-121 Vehicle Lotion | IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Evaluator's Global Severity Score (EGSS) | EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | 'Number analyzed' signifies participants evaluable for this parameter. | Count of Participants | Participants |
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| Noninflammatory Lesion Count | Mean | Standard Deviation | lesion count |
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| Inflammatory Lesion Count | Mean | Standard Deviation | lesion count |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 | Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count. | ITT population included all randomized participants who received study drug. Multiple imputation (Markov Chain Monte Carlo [MCMC]) was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | lesion count | Baseline (Day 0), Week 12 |
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| Primary | Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 | Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately. | ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | lesion count | Baseline, Week 12 |
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| Primary | Percentage of Participants With Treatment Success at Week 12 | Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | ITT population included all randomized participants who received study drug and evaluable for EGSS score. Multiple imputation (MCMC) was used to impute missing values. 1 participant was excluded from analysis of dichotomized EGSS because EGSS was not performed at baseline. | Posted | Number | percentage of participants | Baseline, Week 12 |
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| Secondary | Percent Change From Baseline in Noninflammatory Lesion Count to Week 12 | Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count. | ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | percent change | Baseline, Week 12 |
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| Secondary | Percent Change From Baseline in Inflammatory Lesion Count to Week 12 | Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately. | ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | percent change | Baseline, Week 12 |
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Baseline (Day 0) up to Week 12
Safety population included all randomized participants who were presumed to have used study drug at least once and who provided at least 1 post baseline evaluation.
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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-121 Lotion | IDP-121 lotion (tretinoin 0.05%) was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. | 0 | 378 | 5 | 378 | 0 | 378 |
| EG001 | IDP-121 Vehicle Lotion | IDP-121 lotion vehicle was applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. | 0 | 385 | 2 | 385 | 0 | 385 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v18.0 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
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| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA v18.0 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
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| Appendicitis | Infections and infestations | MedDRA v18.0 | Systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA v18.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v18.0 | Systematic Assessment |
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| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA v18.0 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v18.0 | Systematic Assessment |
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Please contact Sponsor directly for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Director | Bausch Health Americas, Inc. | 1-510-259-5284 | aloncaric@bauschhealth.com |
| Dec 16, 2019 |
| 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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| 1 - Almost Clear |
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| 2 - Mild |
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| 3 - Moderate |
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| 4 - Severe |
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