Trial Outcomes & Findings for A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea (NCT NCT04608500)

Last Updated: 2021-01-07

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

771 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2021-01-07

Participant Flow

Participants were enrolled at 46 sites in the United States from 01 June 2017 - 31 July 2018.

All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All the study assessments were performed as per the schedule of assessment.

Participant milestones

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	514	257
Overall Study COMPLETED	479	239
Overall Study NOT COMPLETED	35	18

Reasons for withdrawal

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	2	0
Overall Study Lost to Follow-up	15	9
Overall Study Participant request	11	7
Overall Study Protocol Violation	1	0
Overall Study Other	6	2

Baseline Characteristics

A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FMX103 1.5% n=514 Participants Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=257 Participants Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.	Total n=771 Participants Total of all reporting groups
Age, Continuous	50.9 years STANDARD_DEVIATION 13.90 • n=5 Participants	50.9 years STANDARD_DEVIATION 13.49 • n=7 Participants	50.9 years STANDARD_DEVIATION 13.75 • n=5 Participants
Sex: Female, Male Female	365 Participants n=5 Participants	168 Participants n=7 Participants	533 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants	89 Participants n=7 Participants	238 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	166 Participants n=5 Participants	86 Participants n=7 Participants	252 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	348 Participants n=5 Participants	171 Participants n=7 Participants	519 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	499 Participants n=5 Participants	250 Participants n=7 Participants	749 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: The intent to treat (ITT) population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.

Outcome measures

Outcome measures
Measure	FMX103 1.5% n=514 Participants Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=257 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	18.38 Lesions Standard Error 0.508	14.53 Lesions Standard Error 0.715

PRIMARY outcome

Timeframe: Week 12

Population: 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

Outcome measures
Measure	FMX103 1.5% n=514 Participants Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=257 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	49.1 Percentage of participants	39.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

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.

Outcome measures

Outcome measures
Measure	FMX103 1.5% n=474 Participants Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=235 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	53.8 Percentage of participants	45.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules.

Outcome measures

Outcome measures
Measure	FMX103 1.5% n=474 Participants Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=235 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	61.45 Percent change Standard Error 1.578	50.16 Percent change Standard Error 2.221

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 8

Population: The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.

Outcome measures

Outcome measures
Measure	FMX103 1.5% n=514 Participants Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=257 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	12.67 Lesions Standard Error 0.484	8.29 Lesions Standard Error 0.678
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 Week 8	17.15 Lesions Standard Error 0.471	12.08 Lesions Standard Error 0.649

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.

Outcome measures

Outcome measures
Measure	FMX103 1.5% n=514 Participants Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=257 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	16.7 Percentage of participants	9.7 Percentage of participants
Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8 Week 8	40.3 Percentage of participants	30.7 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. Analyses using the SAF population were based on the treatment received.

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

Outcome measures
Measure	FMX103 1.5% n=514 Participants Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=257 Participants Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
Number of Participants With Adverse Events (AEs) All adverse events	134 Participants	71 Participants
Number of Participants With Adverse Events (AEs) TEAEs	124 Participants	67 Participants
Number of Participants With Adverse Events (AEs) Serious TEAEs (Serious AEs [SAEs])	1 Participants	2 Participants
Number of Participants With Adverse Events (AEs) Participants with any severe TEAE	2 Participants	2 Participants
Number of Participants With Adverse Events (AEs) Treatment-related TEAEs	13 Participants	6 Participants
Number of Participants With Adverse Events (AEs) Adverse events leading to study discontinuation	2 Participants	0 Participants
Number of Participants With Adverse Events (AEs) TEAEs resulting in death	0 Participants	0 Participants

Adverse Events

FMX103 1.5%

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Vehicle Foam

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FMX103 1.5% n=514 participants at risk Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=257 participants at risk Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/514 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])	0.39% 1/257 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/514 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])	0.39% 1/257 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
General disorders Pyrexia	0.00% 0/514 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])	0.39% 1/257 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
Vascular disorders Hypertension	0.19% 1/514 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])	0.00% 0/257 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])

Other adverse events

Other adverse events
Measure	FMX103 1.5% n=514 participants at risk Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Vehicle Foam n=257 participants at risk Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.
Infections and infestations Upper respiratory tract infection	2.9% 15/514 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])	3.1% 8/257 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
Infections and infestations Viral upper respiratory tract infection	2.7% 14/514 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])	3.1% 8/257 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
Nervous system disorders Headache	2.1% 11/514 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])	2.3% 6/257 • From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])

Additional Information

Iain Stuart, PhD.

Foamix Pharmaceuticals, Inc.

Phone: 1 800-775-7936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60