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The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.
This is an open-label, multicenter, 40-week extension study to evaluate the long-term safety, tolerability, and efficacy of FMX103 1.5% topical foam in the treatment of moderate-to-severe facial papulopustular rosacea. Subjects entering this study will have recently participated in 1 of 2 pivotal, double-blind, vehicle-controlled, safety and efficacy studies (FX2016-11 and FX2016-12 - NCT03142451). Subjects must demonstrate that they are eligible to continue into Study FX2016-13 based on safety evaluations and IGA score performed at Final Visit of one of the previous double-blind studies.
At the completion of the Final Visit in Study FX2016-11 or Study FX2016-12, subjects may be invited to continue into this open-label study for an additional 40 weeks of open-label treatment. A minimum of 400 subjects will be enrolled into from Studies FX2016-11 and FX2016-12. Subjects who elect to continue into this open-label study will receive supplies of active FMX103 1.5% minocycline foam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline Foam 1.5% | Experimental | FMX-103 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMX103 1.5% | Drug | FMX103 1.5% minocycline foam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Inflammatory Lesion Count at Week 40 | Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded. | Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40 |
| Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40 | The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. 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 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline. | At Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded. |
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Inclusion Criteria:
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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| Label | URL |
|---|---|
| Related Info | View source |
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Baseline for the study was conducted at the same time as Visit 5/Week 12 (Final Visit) of Study FX2016-11 or Study FX2016-12. All assessments performed at Visit 5/Week 12 (Final Visit) of Study FX2016-11 or Study FX2016-12 were not repeated but rather recorded as the same assessments at Baseline for this study.
This open-label, multi-center, 40-week extension study was conducted at 70 sites in the United States from 05 September 2017 to 03 January 2019, and enrolled participants from previous double-blind (DB) studies FX2016-11 and FX2016-12.
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| ID | Title | Description |
|---|---|---|
| FG000 | DB-FMX103 1.5% Minocycline Foam | Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion. |
| 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 | Jun 22, 2017 | Oct 28, 2020 |
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| Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34 |
| Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. 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 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline. | At Weeks 4, 10, 16, 22, 28 and Week 34 |
| Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded. | Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34 |
| Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | The questionnaire consisted of questions with responses on scale with scores: as 1 (Very satisfied or Very likely ) to 5 (Very dissatisfied or Very unlikely) for each variable as for example, Easy to use, 1 is very satisfied and 5 is very dissatisfied. The minimum score represented best outcome and higher score represented worst outcome. | At Week 40 |
| Number of Participants With Adverse Events (AEs) | Evaluation of the long-term safety of topical FMX103 1.5% minocycline foam in the treatment of moderate to severe facial papulopustular rosacea for 40 weeks. A Treatment-emergent Adverse Events (TEAEs) was defined as any AE with an onset date after the first dose date of the open-label extension study and before the last application of study drug plus 3 days having been absent pre-treatment or worsened relative to the pre-treatment state. | Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44) |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Foamix Investigational Site # 222 | Rogers | Arkansas | 72758 | United States |
| Foamix Investigational Site # 127 | Fremont | California | 94538 | United States |
| Foamix Investigational Site # 226 | Los Angeles | California | 90045 | United States |
| Foamix Investigational Site # 220 | Murrieta | California | 92562 | United States |
| Foamix Investigational Site # 131 | Oceanside | California | 92056 | United States |
| Foamix Investigational Site # 134 | Sacramento | California | 95819 | United States |
| Foamix Investigational Site # 114 | San Diego | California | 92123 | United States |
| Foamix Investigational Site # 116 | San Luis Obispo | California | 93405 | United States |
| Foamix Investigational Site # 135 | Santa Ana | California | 92705 | United States |
| Foamix Investigational Site # 123 | Santa Monica | California | 90403 | 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 # 109 | Clearwater | Florida | 33757 | United States |
| Foamix Investigational Site # 240 | Fort Myers | Florida | 33912 | United States |
| Foamix Investigational Site # 112 | Hialeah | Florida | 33016 | United States |
| Foamix Investigational Site # 214 | Miami | Florida | 33126 | United States |
| Foamix Investigational Site # 241 | North Miami Beach | Florida | 33162 | United States |
| Foamix Investigational Site # 104 | Ormond Beach | Florida | 32174 | United States |
| Foamix Investigational Site # 121 | Sanford | Florida | 32771 | United States |
| Foamix Investigational Site # 125 | Tampa | Florida | 33609 | United States |
| Foamix Investigational Site # 124 | West Palm Beach | Florida | 33409 | United States |
| Foamix Investigational Site # 118 | Alpharetta | Georgia | 30022 | United States |
| Foamix Investigational Site # 204 | Newnan | Georgia | 78660 | United States |
| Foamix Investigational Site # 233 | Sandy Springs | Georgia | 30328 | United States |
| Foamix Investigational Site # 139 | Snellville | Georgia | 30078 | United States |
| Foamix Investigational Site # 211 | Arlington Heights | Illinois | 60005 | United States |
| Foamix Investigational Site # 138 | New Albany | Indiana | 47150 | United States |
| Foamix Investigational Site # 225 | Newburgh | Indiana | 47630 | 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 # 102 | Metairie | Louisiana | 70006 | United States |
| Foamix Investigational Site # 115 | New Orleans | Louisiana | 70115 | United States |
| Foamix Investigational Site # 110 | Beverly | Massachusetts | 01915 | United States |
| Foamix Investigational Site # 107 | Brighton | Massachusetts | 02135 | United States |
| Foamix Investigational Site # 229 | Watertown | Massachusetts | 02472 | United States |
| Foamix Investigational Site # 137 | Ann Arbor | Michigan | 48103 | United States |
| Foamix Investigational Site # 242 | Bay City | Michigan | 48706 | United States |
| Foamix Investigational Site # 210 | Detroit | Michigan | 48202 | United States |
| Foamix Investigational Site # 103 | Fort Gratiot | Michigan | 48059 | United States |
| Foamix Investigational Site # 120 | Troy | Michigan | 48084 | United States |
| Foamix Investigational Site # 140 | Warren | Michigan | 48088 | United States |
| Foamix Investigational Site # 232 | Fridley | Minnesota | 55432 | United States |
| Foamix Investigational Site # 130 | Saint Joseph | Missouri | 64506 | United States |
| Foamix Investigational Site # 133 | Omaha | Nebraska | 68144 | United States |
| Foamix Investigational Site # 221 | Las Vegas | Nevada | 89128 | United States |
| Foamix Investigational Site # 136 | New York | New York | 10075 | United States |
| Foamix Investigational Site # 111 | Stony Brook | New York | 11790 | United States |
| Foamix Investigational Site # 119 | Charlotte | North Carolina | 28277 | 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 # 234 | Winston-Salem | North Carolina | 27103 | United States |
| Foamix Investigational Site # 101 | Bexley | Ohio | 43209 | United States |
| Foamix Investigational Site # 128 | Dublin | Ohio | 43016 | United States |
| Foamix Investigational Site # 236 | Norman | Oklahoma | 73071 | United States |
| Foamix Investigational Site # 224 | Exton | Pennsylvania | 19341 | United States |
| Foamix Investigational Site # 141 | Jenkintown | Pennsylvania | 19046 | United States |
| Foamix Investigational Site # 129 | Yardley | Pennsylvania | 19067 | United States |
| Foamix Investigational Site # 105 | Johnston | Rhode Island | 02919 | United States |
| Foamix Investigational Site # 231 | Charleston | South Carolina | 29407 | United States |
| Foamix Investigational Site # 106 | Greenville | South Carolina | 29607 | 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 # 132 | Austin | Texas | 78746 | United States |
| Foamix Investigational Site # 117 | Austin | Texas | 78759 | United States |
| Foamix Investigational Site # 201 | Houston | Texas | 77004 | United States |
| Foamix Investigational Site # 206 | Pflugerville | Texas | 78660 | United States |
| Foamix Investigational Site # 108 | San Antonio | Texas | 78213 | 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 # 126 | Salt Lake City | Utah | 84117 | United States |
| Foamix Investigational Site # 216 | Lynchburg | Virginia | 24501 | United States |
| Foamix Investigational Site # 203 | Seattle | Washington | 98104 | United States |
| FG001 | DB-Vehicle Foam | Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated population included all participants who used the study drug at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | DB-FMX103 1.5% Minocycline Foam | Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion. |
| BG001 | DB-Vehicle Foam | Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion. |
| 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 |
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| Ethnicity (NIH/OMB) | 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 From Baseline in Inflammatory Lesion Count at Week 40 | Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded. | All treated population included all participants who used the study drug at least once. Here, overall number of participants analyzed (N) signifies only the participants with available data that were analyzed for the outcome measure. | Posted | Mean | Standard Deviation | Lesions | Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40 |
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| Primary | Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40 | The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. 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 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline. | All treated population included all participants who used the study drug at least once. Here, overall number of participants analyzed (N) signifies only the participants with available data that were analyzed for the outcome measure. | Posted | Number | Percentage of participants | At Week 40 |
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| Secondary | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded. | All treated population included all participants who used the study drug at least once. Here, number analyzed (n) signifies only the participants with available data that were analyzed at given specified week. | Posted | Mean | Standard Deviation | Lesions | Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34 |
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| Secondary | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. 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 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline. | All treated population included all participants who used the study drug at least once. Here, number analyzed (n) signifies only the participants with available data that were analyzed at given specified week. | Posted | Number | Percentage of participants | At Weeks 4, 10, 16, 22, 28 and Week 34 |
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| Secondary | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded. | All treated population included all participants who used the study drug at least once. Here, number analyzed (n) signifies only the participants with available data that were analyzed at given specified week. | Posted | Mean | Standard Deviation | Percent Change | Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34 |
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| Secondary | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | The questionnaire consisted of questions with responses on scale with scores: as 1 (Very satisfied or Very likely ) to 5 (Very dissatisfied or Very unlikely) for each variable as for example, Easy to use, 1 is very satisfied and 5 is very dissatisfied. The minimum score represented best outcome and higher score represented worst outcome. | All treated population included all participants who used the study drug at least once. Here, number analyzed are number of participants analyzed for given variable. | Posted | Number | Participants | At Week 40 |
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| Secondary | Number of Participants With Adverse Events (AEs) | Evaluation of the long-term safety of topical FMX103 1.5% minocycline foam in the treatment of moderate to severe facial papulopustular rosacea for 40 weeks. A Treatment-emergent Adverse Events (TEAEs) was defined as any AE with an onset date after the first dose date of the open-label extension study and before the last application of study drug plus 3 days having been absent pre-treatment or worsened relative to the pre-treatment state. | All treated population included all participants who used the study drug at least once. | Posted | Count of Participants | Participants | Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44) |
|
Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
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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 | Minocycline Foam 1.5% | Participants applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks. | 1 | 332 | 9 | 332 | 8 | 332 |
| EG001 | Vehicle Foam | Participants applied matching vehicle foam topically to the face once daily for 40 weeks. | 0 | 172 | 4 | 172 | 11 | 172 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis perforated | Infections and infestations | MedDRA Version 20.0. | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA Version 20.0. | Non-systematic Assessment |
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| Periorbital cellulitis | Infections and infestations | MedDRA Version 20.0. | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 20.0. | Non-systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA Version 20.0. | Non-systematic Assessment |
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| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA Version 20.0. | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA Version 20.0. | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 20.0. | Non-systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 20.0. | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 20.0. | Non-systematic Assessment |
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| Large intestinal obstruction | Gastrointestinal disorders | MedDRA Version 20.0. | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 20.0. | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 20.0. | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0. | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0. | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | 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 | Jan 8, 2019 | Oct 28, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| 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 |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
|
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Enrolled participants from Study FX2016-11 and Study FX2016-12 (FMX103 1.5% group) applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks in this present Study FX2016-13. Participants were grouped based on their experience in the previous double-blind study, and that all participants received the study drug in an open-label fashion.
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