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| Name | Class |
|---|---|
| Premier Research | OTHER |
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The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:
Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment [IGA] score) will be performed at Weeks 4, 8, and 12 during the study.
Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMX103 1.5% | Experimental | Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed. |
|
| Vehicle foam | Placebo Comparator | Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMX103 minocycline foam 1.5% | Drug | Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime. |
| Measure | Description | Time Frame |
|---|---|---|
| The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count. | Baseline and Week 12 |
| Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline. |
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Inclusion Criteria:
Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:
Presence of or history of erythema and/or flushing on the face.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foamix Investigational Site # 207 | Glendale | Arizona | 85308 | United States | ||
| Foamix Investigational Site # 202 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All the study assessments were performed as per the schedule of assessment.
Participants were enrolled at 46 sites in the United States from 01 June 2017 - 31 July 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | FMX103 1.5% | Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed. |
| FG001 | Vehicle Foam | Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed. |
| 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 | May 12, 2017 | Nov 18, 2020 |
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This is a double-blind study, with limited access to the randomization code. The randomization code will be held in confidence until after the study database is locked and a memo documenting the database lock has been issued. Every effort will be made to retain the integrity of the blind. When issued to the sites, the study drug will be identical in appearance for all participants, regardless of treatment assignment.
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| Vehicle foam | Drug | Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime. |
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| Week 12 |
| The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. | Baseline and Week 12 |
| The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count. | Baseline, Week 4 and Week 8 |
| Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline. | Week 4 and Week 8 |
| Number of Participants With Adverse Events (AEs) | To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A Treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state. | From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit]) |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Foamix Investigational Site # 222 | Rogers | Arkansas | 72758 | United States |
| Foamix Investigational Site #244 | Encino | California | 91436 | United States |
| Foamix Investigational Site #249 | Huntington Beach | California | 92647 | United States |
| Foamix Investigational Site # 226 | Los Angeles | California | 90045 | United States |
| Foamix Investigational Site # 220 | Murrieta | California | 92562 | United States |
| Foamix Investigational Site #251 | North Hollywood | California | 91606 | United States |
| Foamix Investigational Site # 217 | San Diego | California | 92123 | United States |
| Foamix Investigational Site #250 | San Marcos | California | 92078 | United States |
| Foamix Investigational Site # 239 | Temecula | California | 92592 | United States |
| Foamix Investigational Site # 227 | Denver | Colorado | 80209 | United States |
| Foamix Investigational Site # 223 | Boca Raton | Florida | 33486 | United States |
| Foamix Investigational Site # 215 | Boynton Beach | Florida | 33437 | United States |
| Foamix Investigational Site #245 | DeLand | Florida | 32720 | United States |
| Foamix Investigational Site # 240 | Fort Myers | Florida | 33912 | United States |
| Foamix Investigational Site #247 | Hialeah | Florida | 33015 | United States |
| Foamix Investigational Site #252 | Hialeah | Florida | 33106 | United States |
| Foamix Investigational Site # 214 | Miami | Florida | 33126 | United States |
| Foamix Investigational Site #246 | Miami | Florida | 33186 | United States |
| Foamix Investigational Site # 241 | North Miami Beach | Florida | 33162 | United States |
| Foamix Investigational Site #248 | Oldsmar | Florida | 34677 | United States |
| Foamix Investigational Site # 204 | Newnan | Georgia | 78660 | United States |
| Foamix Investigational Site # 211 | Arlington Heights | Illinois | 60005 | United States |
| Foamix Investigational Site # 225 | Newburgh | Indiana | 47630 | United States |
| Foamix Investigational Site #243 | Plainfield | Indiana | 46168 | United States |
| Foamix Investigational Site # 218 | South Bend | Indiana | 46617 | United States |
| Foamix Investigational Site # 235 | Louisville | Kentucky | 40217 | United States |
| Foamix Investigational Site # 237 | Louisville | Kentucky | 40241 | United States |
| Foamix Investigational Site # 229 | Watertown | Massachusetts | 02472 | United States |
| Foamix Investigational Site # 210 | Detroit | Michigan | 48202 | United States |
| Foamix Investigational Site # 232 | Fridley | Minnesota | 55432 | United States |
| Foamix Investigational Site # 238 | High Point | North Carolina | 27262 | United States |
| Foamix Investigational Site # 212 | Raleigh | North Carolina | 27612 | United States |
| Foamix Investigational Site # 236 | Norman | Oklahoma | 73071 | United States |
| Foamix Investigational Site # 224 | Exton | Pennsylvania | 19341 | United States |
| Foamix Investigational Site # 230 | Mt. Pleasant | South Carolina | 29464 | United States |
| Foamix Investigational Site # 228 | Knoxville | Tennessee | 37922 | United States |
| Foamix Investigational Site # 219 | Arlington | Texas | 76011 | United States |
| Foamix Investigational Site # 201 | Houston | Texas | 77004 | United States |
| Foamix Investigational Site # 206 | Pflugerville | Texas | 78660 | United States |
| Foamix Investigational Site # 208 | San Antonio | Texas | 78229 | United States |
| Foamix Investigational Site # 213 | San Antonio | Texas | 78229 | United States |
| Foamix Investigational Site # 209 | Webster | Texas | 77598 | United States |
| Foamix Investigational Site # 216 | Lynchburg | Virginia | 24501 | United States |
| Foamix Investigational Site # 203 | Seattle | Washington | 98104 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FMX103 1.5% | Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed. |
| BG001 | Vehicle Foam | Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed. |
| 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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| 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 | The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count. | The intent to treat (ITT) population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. | Posted | Least Squares Mean | Standard Error | Lesions | Baseline and Week 12 |
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| Primary | Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline. | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline. | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and Week 12 |
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| Secondary | The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count. | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. | Posted | Least Squares Mean | Standard Error | Lesions | Baseline, Week 4 and Week 8 |
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| Secondary | Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8 | To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline. | The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. | Posted | Number | Percentage of participants | Week 4 and Week 8 |
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| Secondary | Number of Participants With Adverse Events (AEs) | To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A Treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state. | The Safety (SAF) population included all randomized participants who used at least 1 dose of study drug, including participants who had no post-Baseline assessments unless all dispensed study drug was returned unused. Analyses using the SAF population were based on the treatment received. | Posted | Number | Participants | From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit]) |
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From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
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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 | FMX103 1.5% | Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed. | 0 | 514 | 1 | 514 | 39 | 514 |
| EG001 | Vehicle Foam | Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed. | 0 | 257 | 2 | 257 | 22 | 257 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 20.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 20.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA, Version 20.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA, Version 20.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 20.0 | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA, Version 20.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA, Version 20.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iain Stuart, PhD. | Foamix Pharmaceuticals, Inc. | 1 800-775-7936 | Iain.Stuart@foamix.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 9, 2018 | Nov 18, 2020 | SAP_001.pdf |
| 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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