Trial Outcomes & Findings for A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea (NCT NCT03276936)
NCT ID: NCT03276936
Last Updated: 2022-01-18
Results Overview
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.
COMPLETED
PHASE3
504 participants
Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40
2022-01-18
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
332
|
172
|
|
Overall Study
COMPLETED
|
276
|
134
|
|
Overall Study
NOT COMPLETED
|
56
|
38
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
16
|
13
|
|
Overall Study
Withdrawal by Subject
|
30
|
20
|
|
Overall Study
Not mentioned
|
6
|
3
|
Baseline Characteristics
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
Baseline characteristics by cohort
| Measure |
DB-FMX103 1.5% Minocycline Foam
n=332 Participants
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.
|
DB-Vehicle Foam
n=172 Participants
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.
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.1 Years
STANDARD_DEVIATION 12.62 • n=39 Participants
|
51.9 Years
STANDARD_DEVIATION 11.90 • n=41 Participants
|
51.4 Years
STANDARD_DEVIATION 12.37 • n=35 Participants
|
|
Sex: Female, Male
Female
|
241 Participants
n=39 Participants
|
110 Participants
n=41 Participants
|
351 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=39 Participants
|
62 Participants
n=41 Participants
|
153 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
93 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
269 Participants
n=39 Participants
|
141 Participants
n=41 Participants
|
410 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
321 Participants
n=39 Participants
|
163 Participants
n=41 Participants
|
484 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40Population: 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.
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.
Outcome measures
| Measure |
DB-FMX103 1.5% Minocycline Foam
n=272 Participants
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.
|
DB-Vehicle Foam
n=129 Participants
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.
|
|---|---|---|
|
Absolute Change From Baseline in Inflammatory Lesion Count at Week 40
|
23.0 Lesions
Standard Deviation 10.96
|
22.5 Lesions
Standard Deviation 10.83
|
PRIMARY outcome
Timeframe: At Week 40Population: 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.
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.
Outcome measures
| Measure |
DB-FMX103 1.5% Minocycline Foam
n=272 Participants
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.
|
DB-Vehicle Foam
n=129 Participants
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.
|
|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40
|
81.6 Percentage of participants
|
76.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34Population: 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.
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.
Outcome measures
| Measure |
DB-FMX103 1.5% Minocycline Foam
n=332 Participants
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.
|
DB-Vehicle Foam
n=172 Participants
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.
|
|---|---|---|
|
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
|
17.4 Lesions
Standard Deviation 12.18
|
|
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
|
19.8 Lesions
Standard Deviation 12.92
|
|
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
|
20.0 Lesions
Standard Deviation 13.09
|
|
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
|
21.7 Lesions
Standard Deviation 10.89
|
|
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
|
20.7 Lesions
Standard Deviation 11.33
|
|
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
|
22.5 Lesions
Standard Deviation 10.71
|
SECONDARY outcome
Timeframe: At Weeks 4, 10, 16, 22, 28 and Week 34Population: 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.
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.
Outcome measures
| Measure |
DB-FMX103 1.5% Minocycline Foam
n=332 Participants
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.
|
DB-Vehicle Foam
n=172 Participants
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.
|
|---|---|---|
|
Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
Week 4
|
50.6 Percentage of participants
|
48.2 Percentage of participants
|
|
Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
Week 10
|
60.1 Percentage of participants
|
54.5 Percentage of participants
|
|
Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
Week 16
|
68.1 Percentage of participants
|
64.0 Percentage of participants
|
|
Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
Week 34
|
73.5 Percentage of participants
|
72.1 Percentage of participants
|
|
Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
Week 22
|
69.1 Percentage of participants
|
64.4 Percentage of participants
|
|
Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34
Week 28
|
72.4 Percentage of participants
|
65.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34Population: 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.
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.
Outcome measures
| Measure |
DB-FMX103 1.5% Minocycline Foam
n=332 Participants
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.
|
DB-Vehicle Foam
n=172 Participants
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.
|
|---|---|---|
|
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
|
61.25 Percent Change
Standard Deviation 32.306
|
|
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
|
69.02 Percent Change
Standard Deviation 32.966
|
|
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
|
71.46 Percent Change
Standard Deviation 33.230
|
|
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
|
73.63 Percent Change
Standard Deviation 27.515
|
|
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
|
77.06 Percent Change
Standard Deviation 25.863
|
|
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
|
80.38 Percent Change
Standard Deviation 22.873
|
SECONDARY outcome
Timeframe: At Week 40Population: 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.
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.
Outcome measures
| Measure |
DB-FMX103 1.5% Minocycline Foam
n=332 Participants
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.
|
DB-Vehicle Foam
n=172 Participants
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.
|
|---|---|---|
|
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
|
2 Participants
|
|
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
|
47 Participants
|
|
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
|
82 Participants
|
|
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
|
3 Participants
|
|
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
|
44 Participants
|
|
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
|
7 Participants
|
|
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
|
0 Participants
|
|
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
|
75 Participants
|
|
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
|
78 Participants
|
|
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
|
0 Participants
|
|
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
|
88 Participants
|
|
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
|
0 Participants
|
|
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
|
83 Participants
|
|
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
|
70 Participants
|
|
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
|
2 Participants
|
|
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
|
74 Participants
|
|
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
|
5 Participants
|
|
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
|
75 Participants
|
|
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
|
1 Participants
|
|
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
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
DB-FMX103 1.5% Minocycline Foam
n=332 Participants
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.
|
DB-Vehicle Foam
n=172 Participants
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.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Death
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
All AEs
|
151 Participants
|
70 Participants
|
|
Number of Participants With Adverse Events (AEs)
TEAEs
|
137 Participants
|
64 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious TEAEs
|
9 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related TEAEs
|
5 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse events leading to study discontinuation
|
3 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
Participants with any severe TEAE
|
6 Participants
|
6 Participants
|
Adverse Events
Minocycline Foam 1.5%
Vehicle Foam
Serious adverse events
| Measure |
Minocycline Foam 1.5%
n=332 participants at risk
Participants applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks.
|
Vehicle Foam
n=172 participants at risk
Participants applied matching vehicle foam topically to the face once daily for 40 weeks.
|
|---|---|---|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.58%
1/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Infections and infestations
Labyrinthitis
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Infections and infestations
Periorbital cellulitis
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Infections and infestations
Pneumonia
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Infections and infestations
Staphylococcal infection
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Nervous system disorders
Syncope
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.58%
1/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.58%
1/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
General disorders
Death
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.30%
1/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.00%
0/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
0.58%
1/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
Other adverse events
| Measure |
Minocycline Foam 1.5%
n=332 participants at risk
Participants applied FMX103 1.5% minocycline foam topically to the face once daily for 40 weeks.
|
Vehicle Foam
n=172 participants at risk
Participants applied matching vehicle foam topically to the face once daily for 40 weeks.
|
|---|---|---|
|
Infections and infestations
Sinusitis
|
2.4%
8/332 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
6.4%
11/172 • Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60