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The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifarotene Cream + Doxycycline | Experimental | Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. |
|
| Trifarotene Vehicle + Doxycycline Placebo | Placebo Comparator | Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifarotene cream | Drug | Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Facial Total Lesion Counts to Week 12 | Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face. | From Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12 | All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator. | From Baseline to Week 12 |
| Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | Fort Smith | Arkansas | 72916 | United States | ||
| Galderma Investigational Site |
A total of 202 participants were randomized in 2:1 ratio in 2 treatment groups.
Study was conducted at United States of America and Puerto Rico between 29 Jul 2020 and 26 Apr 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trifarotene (CD5789) Cream + Doxycycline | Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. |
| 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 21, 2020 | Apr 4, 2022 |
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| Doxycycline hyclate | Drug | Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks. |
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| Trifarotene Vehicle | Drug | Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks. |
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| Doxycycline Placebo | Drug | Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks. |
|
Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator. |
| From Baseline to Week 12 |
| Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12 | IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12. | From Baseline to Week 12 |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Galderma Investigational Site | Rogers | Arkansas | 72758 | United States |
| Galderma Investigational Site | Newport Beach | California | 92663 | United States |
| Galderma Investigational Site | Aventura | Florida | 33180 | United States |
| Galderma Investigational Site | Boca Raton | Florida | 33486 | United States |
| Galderma Investigational Site | Miramar | Florida | 33027 | United States |
| Galderma Investigational Site | Newnan | Georgia | 30263 | United States |
| Galderma Investigational Site | Evansville | Indiana | 47715 | United States |
| Galderma Investigational Site | New Albany | Indiana | 47150 | United States |
| Galderma Investigational Site | Rockville | Maryland | 20850 | United States |
| Galderma Investigational Site | Warren | Michigan | 48088 | United States |
| Galderma Investigational Site | New Brighton | Minnesota | 55112 | United States |
| Galderma Investigational Site | Las Vegas | Nevada | 89148 | United States |
| Galderma Investigational Site | Stony Brook | New York | 11790 | United States |
| Galderma Investigational Site | High Point | North Carolina | 27262 | United States |
| Galderma Investigational Site | Sugarloaf | Pennsylvania | 18249 | United States |
| Galderma Investigational Site | Charleston | South Carolina | 71913 | United States |
| Galderma Investigational Site | Knoxville | Tennessee | 37922 | United States |
| Galderma Investigational Site | Arlington | Texas | 76011 | United States |
| Galderma Investigational Site | Dallas | Texas | 75246 | United States |
| Galderma Investigational Site | Grapevine | Texas | 76051 | United States |
| Galderma Investigational Site | Pflugerville | Texas | 78660 | United States |
| Galderma Investigational Site | San Antonio | Texas | 78218 | United States |
| Galderma Investigational Site | San Antonio | Texas | 78249 | United States |
| Galderma Investigational Site | Aibonito | 705 | Puerto Rico |
| FG001 |
| Trifarotene Vehicle + Doxycycline Placebo |
Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on Intent to treat (ITT) population that included all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trifarotene + Doxycycline | Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. |
| BG001 | Trifarotene Vehicle + Doxycycline Placebo | Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week 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 |
| ||||||||||||||||
| Facial Total Lesions Counts | Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and noninflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face. | Mean | Standard Deviation | Lesion counts |
|
| 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 Facial Total Lesion Counts to Week 12 | Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face. | The ITT population included all participants who were randomized. | Posted | Least Squares Mean | Standard Deviation | Lesion counts | From Baseline to Week 12 |
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| Secondary | Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12 | All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator. | The ITT population included all participants who were randomized. | Posted | Least Squares Mean | Standard Error | Lesion counts | From Baseline to Week 12 |
|
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| Secondary | Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12 | Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator. | The ITT population included all participants who were randomized. | Posted | Least Squares Mean | Standard Deviation | Lesion counts | From Baseline to Week 12 |
|
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| Secondary | Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12 | IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12. | The ITT population included all participants who were randomized. | Posted | Number | percentage of participants | From Baseline to Week 12 |
|
From Baseline up to Week 12.
Analysis was performed on safety population which comprised of all randomized participants who applied/took the study drug at least once.
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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 + Doxycycline | Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. | 0 | 133 | 1 | 133 | 0 | 133 |
| EG001 | Trifarotene Vehicle + Doxycycline Placebo | Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks. | 0 | 69 | 0 | 69 | 0 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self-Injurious Ideation | Psychiatric disorders | MedDRA Version 23 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2021 | Apr 4, 2022 | SAP_001.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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| ID | Term |
|---|---|
| C000629420 | trifarotene |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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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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