Trial Outcomes & Findings for A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea (NCT NCT03142451)
NCT ID: NCT03142451
Last Updated: 2021-01-29
Results Overview
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.
COMPLETED
PHASE3
751 participants
Baseline and Week 12
2021-01-29
Participant Flow
Participant milestones
| Measure |
FMX103 1.5%
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
Overall Study
STARTED
|
495
|
256
|
|
Overall Study
COMPLETED
|
437
|
232
|
|
Overall Study
NOT COMPLETED
|
58
|
24
|
Reasons for withdrawal
| Measure |
FMX103 1.5%
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
25
|
8
|
|
Overall Study
Participant request
|
24
|
12
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
Baseline characteristics by cohort
| Measure |
FMX103 1.5%
n=495 Participants
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=256 Participants
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
Total
n=751 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 13.71 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 12.85 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 13.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
355 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
541 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
165 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
328 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
496 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
474 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
715 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The intent-to-treat (ITT) population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.
Outcome measures
| Measure |
FMX103 1.5%
n=495 Participants
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=256 Participants
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12
|
17.56 Lesions
Standard Error 0.442
|
15.34 Lesions
Standard Error 0.604
|
PRIMARY outcome
Timeframe: Week 12Population: The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline.
Outcome measures
| Measure |
FMX103 1.5%
n=495 Participants
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=256 Participants
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12
|
52.1 Percentage of participants
|
43.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
Outcome measures
| Measure |
FMX103 1.5%
n=423 Participants
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=225 Participants
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12
|
55.3 Percentage of participants
|
45.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
Outcome measures
| Measure |
FMX103 1.5%
n=423 Participants
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=225 Participants
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12
|
64.13 Percent change
Standard Error 1.584
|
56.52 Percent change
Standard Error 2.133
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. The change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.
Outcome measures
| Measure |
FMX103 1.5%
n=495 Participants
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=256 Participants
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8
Week 4
|
11.24 Lesions
Standard Error 0.441
|
8.62 Lesions
Standard Error 0.608
|
|
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8
Week 8
|
15.59 Lesions
Standard Error 0.445
|
12.51 Lesions
Standard Error 0.610
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline.
Outcome measures
| Measure |
FMX103 1.5%
n=495 Participants
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=256 Participants
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8
Week 4
|
15.3 Percentage of participants
|
9.1 Percentage of participants
|
|
Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8
Week 8
|
35.2 Percentage of participants
|
29.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])Population: The Safety (SAF) population included all randomized participants who used at least 1 dose of study drug, including participants who had no post-Baseline assessments unless all dispensed study drug was returned unused.
To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state.
Outcome measures
| Measure |
FMX103 1.5%
n=494 Participants
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=256 Participants
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
All AEs
|
98 Participants
|
58 Participants
|
|
Number of Participants With Adverse Events (AEs)
TEAEs
|
91 Participants
|
54 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious TEAEs (SAEs)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)
Participants with any severe TEAE
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related TEAEs
|
8 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to study discontinuation
|
5 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
TEAEs resulting in death
|
0 Participants
|
1 Participants
|
Adverse Events
FMX103 1.5%
Vehicle Foam
Serious adverse events
| Measure |
FMX103 1.5%
n=494 participants at risk
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=256 participants at risk
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.39%
1/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.39%
1/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.39%
1/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.00%
0/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
General disorders
Chest discomfort
|
0.20%
1/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.00%
0/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
General disorders
Chest pain
|
0.00%
0/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.39%
1/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
General disorders
Fatigue
|
0.20%
1/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.00%
0/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
Immune system disorders
Seasonal allergy
|
0.20%
1/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.00%
0/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
1/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.00%
0/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
Nervous system disorders
Syncope
|
0.20%
1/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.00%
0/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
1/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.00%
0/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
|
Vascular disorders
Hypertension
|
0.00%
0/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
0.39%
1/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
Other adverse events
| Measure |
FMX103 1.5%
n=494 participants at risk
Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
|
Vehicle Foam
n=256 participants at risk
Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.81%
4/494 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
2.0%
5/256 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60