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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003608-41 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifarotene (CD5789) 50 mcg/g Cream | Experimental |
| |
| Trifarotene Vehicle Cream | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifarotene Cream | Drug | Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream on the face once daily, in the evening for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24 | The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \ | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in PIH ODS Scores at Week 24 | The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \ |
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Key Inclusion Criteria:
Participant with clinical diagnosis of acne vulgaris, defined by:
Participant with any Fitzpatrick Skin Type I to VI (target patient enrollment according to FST)
Female participants of childbearing potential must have a negative urine pregnancy test (UPT) at Baseline visit
Female participants of childbearing potential must agree to use an adequate and approved method of contraception throughout the study
Female participant of non-childbearing potential
Other protocol defined inclusion criteria could apply
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site #8636 | Fountain Valley | California | 92708 | United States | ||
| Galderma Investigational Site #8224 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41286546 | Derived | Dias-Barbosa C, Taylor N, Chan K, York JP, Puelles J, Chavda R. Patient Insights on Acne Hyperpigmentation, Trifarotene, and Skincare: 6-Month, LEAP Phase 4 Qualitative Exit Interview Findings. Patient. 2026 Mar;19(2):343-352. doi: 10.1007/s40271-025-00789-9. Epub 2025 Nov 24. |
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A total of 150 participants were screened, out of which 123 participants were randomized and enrolled in two treatment groups. 60 participants were randomized in Trifarotene (CD5789) Cream treatment group and 63 were assigned in Trifarotene Vehicle Cream treatment group.
The study was conducted at 18 investigational centers in the United States and Spain from 22 Dec 2021 to 15 Dec 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trifarotene (CD5789) Cream | Participants applied Trifarotene 50 micrograms per gram (mcg/g) cream on face once daily in the evening for 24 weeks. |
| FG001 | Trifarotene Vehicle Cream |
| 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 | Yes | No | No | Study Protocol | Aug 24, 2021 | Nov 2, 2023 |
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| Trifarotene Vehicle Cream | Drug | Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks |
|
| Baseline and Week 24 |
| Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 | The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \ | Baseline, at Week 12, Week 16 and Week 20 |
| Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20 | The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \ | Baseline, at Week 12, Week 16 and Week 20 |
| Fremont |
| California |
| 94538 |
| United States |
| Galderma Investigational Site #8358 | San Diego | California | 92108 | United States |
| Galderma Investigational Site #9955 | San Diego | California | 92123 | United States |
| Galderma Investigational Site #7012 | Lutz | Florida | 33549 | United States |
| Galderma Investigational Site #8184 | Maitland | Florida | 32751 | United States |
| Galderma Investigational Site #8764 | Tampa | Florida | 33613 | United States |
| Galderma Investigational Site #9950 | Evansville | Indiana | 47714 | United States |
| Galderma Investigational Site #9952 | Baton Rouge | Louisiana | 70808 | United States |
| Galderma Investigational Site #8606 | New Orleans | Louisiana | 70115 | United States |
| Galderma Investigational Site #8012 | Glenn Dale | Maryland | 20769 | United States |
| Galderma Investigational Site #9948 | Hyattsville | Maryland | 20782 | United States |
| Galderma Investigational Site #8554 | Detroit | Michigan | 48202 | United States |
| Galderma Investigational Site #8108 | Las Vegas | Nevada | 89148 | United States |
| Galderma Investigational Site #8620 | New York | New York | 10025 | United States |
| Galderma Investigational Site #9956 | New York | New York | 10025 | United States |
| Galderma Investigational Site #9949 | New York | New York | 10155 | United States |
| Galderma Investigational Site #9953 | Tulsa | Oklahoma | 74133 | United States |
| Galderma Investigational Site #8207 | Nashville | Tennessee | 37215 | United States |
| Galderma Investigational Site #9920 | Arlington | Texas | 76011 | United States |
| Galderma Investigational Site #8329 | San Antonio | Texas | 78229 | United States |
| Galderma Investigational Site #8433 | San Antonio | Texas | 78229 | United States |
| Galderma Investigational Site #6192 | Zaragoza | Aragon | 50009 | Spain |
| Galderma Investigational Site #6278 | Manises | Valencia | 46940 | Spain |
| Galderma Investigational Site #6277 | Pontevedra | 36071 | Spain |
Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Trifarotene (CD5789) Cream | Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks. |
| BG001 | Trifarotene Vehicle Cream | Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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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| 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 From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24 | The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \ | The Intent to Treat (ITT) population included all participants who were randomized. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 24 |
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| Secondary | Percent Change From Baseline in PIH ODS Scores at Week 24 | The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \ | The ITT population included all participants who were randomized. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and Week 24 |
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| Secondary | Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 | The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \ | The ITT population included all participants who were randomized. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, at Week 12, Week 16 and Week 20 |
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| Secondary | Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20 | The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \ | The ITT population included all participants who were randomized. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, at Week 12, Week 16 and Week 20 |
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Adverse events were assessed from screening up to Week 24
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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 | Trifarotene (CD5789) Cream | Participants applied Trifarotene 50 mcg/g cream on face once daily in the evening for 24 weeks. | 0 | 60 | 0 | 60 | 10 | 60 |
| EG001 | Trifarotene Vehicle Cream | Participants applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks. | 0 | 63 | 1 | 63 | 19 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bipolar Disorder | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA Version 24.1. | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 24.1. | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 24.1. | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | MedDRA Version 24.1. | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA Version 24.1. | Systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA Version 24.1. | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA Version 24.1. | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 24.1. | Systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA Version 24.1. | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Headached | Nervous system disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Application site burn | General disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 24.1. | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Hair follicle tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1. | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Bipolar I disorder | Psychiatric disorders | MedDRA Version 24.1. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist | Galderma | +46184749000 | reception.seupp@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2023 | Nov 2, 2023 | SAP_001.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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| ID | Term |
|---|---|
| C000629420 | trifarotene |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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