Papulopustular Rosacea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGFMX103 1.5%
FMX103 1.5% minocycline foam
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12. 2. Have not had a worsening of disease, determined by the Investigator's Global Assessment (IGA), at Visit 5/Week 12 (Final Visit) relative to the Day 0/Baseline assessment in Study FX2016-11 or Study FX2016-12.
Exclusion criteria
1. Have a new systemic disease or condition, including an ongoing AE that might interfere with the conduct of the study or the interpretation of results. 2. Have developed a condition that would have been exclusionary for Study FX2016-11 or Study FX2016-12, including pseudomembranous colitis, antibiotic associated colitis, hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Inflammatory Lesion Count at Week 40 | Day 0/ Baseline (Final visit of previous DB study [Week 12]) and 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. |
| Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Day 0/ Baseline (Final visit of previous DB study [Week 12]) and 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. |
| Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Day 0/ Baseline (Final visit of previous DB study [Week 12]) and 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. |
| Number of Participants With Adverse Events (AEs) | Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44) | 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. |
| Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | 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. |
| Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | At Weeks 4, 10, 16, 22, 28 and Week 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 332 |
| 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. | 172 |
| Total | 504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Lost to Follow-up | 16 | 13 |
| Overall Study | Not mentioned | 6 | 3 |
| Overall Study | Withdrawal by Subject | 30 | 20 |
Baseline characteristics
| Characteristic | DB-Vehicle Foam | Total | DB-FMX103 1.5% Minocycline Foam |
|---|---|---|---|
| Age, Continuous | 51.9 Years STANDARD_DEVIATION 11.9 | 51.4 Years STANDARD_DEVIATION 12.37 | 51.1 Years STANDARD_DEVIATION 12.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 93 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 141 Participants | 410 Participants | 269 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 163 Participants | 484 Participants | 321 Participants |
| Sex: Female, Male Female | 110 Participants | 351 Participants | 241 Participants |
| Sex: Female, Male Male | 62 Participants | 153 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 332 | 0 / 172 |
| other Total, other adverse events | 8 / 332 | 11 / 172 |
| serious Total, serious adverse events | 9 / 332 | 4 / 172 |
Outcome results
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.
Time frame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB-FMX103 1.5% Minocycline Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Week 40 | 23.0 Lesions | Standard Deviation 10.96 |
| DB-Vehicle Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Week 40 | 22.5 Lesions | Standard Deviation 10.83 |
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.
Time frame: At Week 40
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB-FMX103 1.5% Minocycline Foam | Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40 | 81.6 Percentage of participants |
| DB-Vehicle Foam | Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40 | 76.0 Percentage of participants |
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.
Time frame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB-FMX103 1.5% Minocycline Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 10 | 20.4 Lesions | Standard Deviation 11.62 |
| DB-FMX103 1.5% Minocycline Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 22 | 22.2 Lesions | Standard Deviation 12.35 |
| DB-FMX103 1.5% Minocycline Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 34 | 23.2 Lesions | Standard Deviation 11.75 |
| DB-FMX103 1.5% Minocycline Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 28 | 22.4 Lesions | Standard Deviation 11.89 |
| DB-FMX103 1.5% Minocycline Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 4 | 19.5 Lesions | Standard Deviation 11.57 |
| DB-FMX103 1.5% Minocycline Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 16 | 21.9 Lesions | Standard Deviation 11.38 |
| DB-Vehicle Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 34 | 22.5 Lesions | Standard Deviation 10.71 |
| DB-Vehicle Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 16 | 20.0 Lesions | Standard Deviation 13.09 |
| DB-Vehicle Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 4 | 17.4 Lesions | Standard Deviation 12.18 |
| DB-Vehicle Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 22 | 20.7 Lesions | Standard Deviation 11.33 |
| DB-Vehicle Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 28 | 21.7 Lesions | Standard Deviation 10.89 |
| DB-Vehicle Foam | Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 10 | 19.8 Lesions | Standard Deviation 12.92 |
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.
Time frame: At Week 40
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Compared to Other Products;1-Very satisfied | 144 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Color; 5-Very dissatisfied | 10 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Feel on Skin; 1-Very satisfied | 110 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Ease of application; 1-Very satisfied | 183 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Overall Satisfaction with Product; 1-Very satisfied | 155 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Ease of application; 5-Very dissatisfied | 0 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Feel on Skin; 5-Very dissatisfied | 3 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Ease fitting in to daily routine; 1-Very satisfied | 155 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Overall Satisfaction with Product; 5-Very dissatisfied | 2 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Ease fitting in to daily routine; 5-Very dissatisfied | 0 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Odor; 1-Very satisfied | 155 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Recommend to friend; 5-Very unlikely | 3 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Use with other rosacea treatments; 5-Very unlikely | 3 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Compared to Other Products; 5-Very dissatisfied | 1 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Odor; 5-Very dissatisfied | 0 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Use with other rosacea treatments; 1-Very likely | 153 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Easy to Use; 5-Very dissatisfied | 0 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Color; 1-Very satisfied | 107 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Recommend to friend; 1-Very likely | 156 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Easy to Use; 1-Very satisfied | 178 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Overall Satisfaction with Product; 1-Very satisfied | 75 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Easy to Use; 1-Very satisfied | 82 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Recommend to friend; 1-Very likely | 75 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Recommend to friend; 5-Very unlikely | 1 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Overall Satisfaction with Product; 5-Very dissatisfied | 1 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Easy to Use; 5-Very dissatisfied | 2 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Feel on Skin; 1-Very satisfied | 47 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Feel on Skin; 5-Very dissatisfied | 3 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Odor; 1-Very satisfied | 78 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Odor; 5-Very dissatisfied | 0 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Color; 1-Very satisfied | 44 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Color; 5-Very dissatisfied | 7 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Ease of application; 1-Very satisfied | 88 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Ease of application; 5-Very dissatisfied | 0 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Ease fitting in to daily routine; 1-Very satisfied | 83 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Ease fitting in to daily routine; 5-Very dissatisfied | 0 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Compared to Other Products;1-Very satisfied | 70 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Compared to Other Products; 5-Very dissatisfied | 2 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Use with other rosacea treatments; 1-Very likely | 74 Participants |
| DB-Vehicle Foam | Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 | Use with other rosacea treatments; 5-Very unlikely | 5 Participants |
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.
Time frame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
Population: All treated population included all participants who used the study drug at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DB-FMX103 1.5% Minocycline Foam | Number of Participants With Adverse Events (AEs) | Serious TEAEs | 9 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants With Adverse Events (AEs) | Adverse events leading to study discontinuation | 3 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants With Adverse Events (AEs) | TEAEs | 137 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants With Adverse Events (AEs) | Participants with any severe TEAE | 6 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants With Adverse Events (AEs) | Treatment-related TEAEs | 5 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants With Adverse Events (AEs) | Death | 1 Participants |
| DB-FMX103 1.5% Minocycline Foam | Number of Participants With Adverse Events (AEs) | All AEs | 151 Participants |
| DB-Vehicle Foam | Number of Participants With Adverse Events (AEs) | Death | 0 Participants |
| DB-Vehicle Foam | Number of Participants With Adverse Events (AEs) | All AEs | 70 Participants |
| DB-Vehicle Foam | Number of Participants With Adverse Events (AEs) | TEAEs | 64 Participants |
| DB-Vehicle Foam | Number of Participants With Adverse Events (AEs) | Serious TEAEs | 4 Participants |
| DB-Vehicle Foam | Number of Participants With Adverse Events (AEs) | Treatment-related TEAEs | 8 Participants |
| DB-Vehicle Foam | Number of Participants With Adverse Events (AEs) | Adverse events leading to study discontinuation | 2 Participants |
| DB-Vehicle Foam | Number of Participants With Adverse Events (AEs) | Participants with any severe TEAE | 6 Participants |
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.
Time frame: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB-FMX103 1.5% Minocycline Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 4 | 67.91 Percent Change | Standard Deviation 27.569 |
| DB-FMX103 1.5% Minocycline Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 28 | 78.82 Percent Change | Standard Deviation 23.439 |
| DB-FMX103 1.5% Minocycline Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 34 | 81.91 Percent Change | Standard Deviation 20.549 |
| DB-FMX103 1.5% Minocycline Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 10 | 72.43 Percent Change | Standard Deviation 27.937 |
| DB-FMX103 1.5% Minocycline Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 16 | 77.36 Percent Change | Standard Deviation 22.739 |
| DB-FMX103 1.5% Minocycline Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 22 | 77.51 Percent Change | Standard Deviation 25.101 |
| DB-Vehicle Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 16 | 71.46 Percent Change | Standard Deviation 33.23 |
| DB-Vehicle Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 4 | 61.25 Percent Change | Standard Deviation 32.306 |
| DB-Vehicle Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 10 | 69.02 Percent Change | Standard Deviation 32.966 |
| DB-Vehicle Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 28 | 77.06 Percent Change | Standard Deviation 25.863 |
| DB-Vehicle Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 22 | 73.63 Percent Change | Standard Deviation 27.515 |
| DB-Vehicle Foam | Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 | Week 34 | 80.38 Percent Change | Standard Deviation 22.873 |
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.
Time frame: At Weeks 4, 10, 16, 22, 28 and Week 34
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB-FMX103 1.5% Minocycline Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 10 | 60.1 Percentage of participants |
| DB-FMX103 1.5% Minocycline Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 22 | 69.1 Percentage of participants |
| DB-FMX103 1.5% Minocycline Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 28 | 72.4 Percentage of participants |
| DB-FMX103 1.5% Minocycline Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 16 | 68.1 Percentage of participants |
| DB-FMX103 1.5% Minocycline Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 34 | 73.5 Percentage of participants |
| DB-FMX103 1.5% Minocycline Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 4 | 50.6 Percentage of participants |
| DB-Vehicle Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 34 | 72.1 Percentage of participants |
| DB-Vehicle Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 4 | 48.2 Percentage of participants |
| DB-Vehicle Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 10 | 54.5 Percentage of participants |
| DB-Vehicle Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 16 | 64.0 Percentage of participants |
| DB-Vehicle Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 22 | 64.4 Percentage of participants |
| DB-Vehicle Foam | Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 | Week 28 | 65.9 Percentage of participants |