Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris (NCT NCT03271021)

NCT ID: NCT03271021

Last Updated: 2022-01-18

Results Overview

A decrease in the inflammatory lesion count from Baseline to Week 12.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1488 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	FMX101, 4% Minocycline Foam FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Overall Study STARTED	738	750
Overall Study COMPLETED	649	644
Overall Study NOT COMPLETED	89	106

Reasons for withdrawal

Reasons for withdrawal
Measure	FMX101, 4% Minocycline Foam FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Overall Study Adverse Event	3	2
Overall Study Withdrawal by Subject	36	53
Overall Study Lost to Follow-up	34	39
Overall Study Protocol Violation	6	4
Overall Study Abnormal Lab Results	1	0
Overall Study Miscellaneous	9	8

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FMX101, 4% Minocycline Foam n=738 Participants FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam n=750 Participants Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam	Total n=1488 Participants Total of all reporting groups
Age, Customized 9-12	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants
Age, Customized 13-17	321 Participants n=5 Participants	309 Participants n=7 Participants	630 Participants n=5 Participants
Age, Customized ≥ 18	375 Participants n=5 Participants	400 Participants n=7 Participants	775 Participants n=5 Participants
Sex: Female, Male Female	460 Participants n=5 Participants	469 Participants n=7 Participants	929 Participants n=5 Participants
Sex: Female, Male Male	278 Participants n=5 Participants	281 Participants n=7 Participants	559 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	266 Participants n=5 Participants	252 Participants n=7 Participants	518 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	472 Participants n=5 Participants	498 Participants n=7 Participants	970 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	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	125 Participants n=5 Participants	144 Participants n=7 Participants	269 Participants n=5 Participants
Race (NIH/OMB) White	571 Participants n=5 Participants	560 Participants n=7 Participants	1131 Participants n=5 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

A decrease in the inflammatory lesion count from Baseline to Week 12.

Outcome measures

Outcome measures
Measure	FMX101, 4% Minocycline Foam n=738 Participants FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam n=750 Participants Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.	16.39 Lesion Count Interval 15.53 to 17.25	12.74 Lesion Count Interval 11.88 to 13.61

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	FMX101, 4% Minocycline Foam n=738 Participants FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam n=750 Participants Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline	199 participants	133 participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	FMX101, 4% Minocycline Foam n=626 Participants FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam n=622 Participants Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12	18.80 Lesion Count Interval 17.06 to 20.54	15.89 Lesion Count Interval 14.14 to 17.65

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Outcome measures
Measure	FMX101, 4% Minocycline Foam n=738 Participants FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam n=750 Participants Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9	15.59 Lesion Count Interval 14.8 to 16.38	11.72 Lesion Count Interval 10.92 to 12.52

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	FMX101, 4% Minocycline Foam n=738 Participants FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam n=750 Participants Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6	13.09 Lesion Count Interval 12.29 to 13.89	9.57 Lesion Count Interval 8.76 to 110.37

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	FMX101, 4% Minocycline Foam n=738 Participants FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam n=750 Participants Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6	84 participants	46 participants

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Outcome measures
Measure	FMX101, 4% Minocycline Foam n=738 Participants FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam n=750 Participants Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9	137 participants	79 participants

Adverse Events

FMX101, 4% Minocycline Foam

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Foam

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FMX101, 4% Minocycline Foam n=737 participants at risk FMX101, 4% minocycline foam applied topically once daily for 12 weeks FMX101: FMX101, 4% minocycline foam	Vehicle Foam n=747 participants at risk Vehicle foam applied topically once daily for 12 weeks Vehicle Foam: Vehicle Foam
Hepatobiliary disorders Cholecystitis	0.00% 0/737 • Up to 16 weeks Number of participants represents the Safety Population.	0.13% 1/747 • Number of events 1 • Up to 16 weeks Number of participants represents the Safety Population.
Gastrointestinal disorders Chron's disease	0.00% 0/737 • Up to 16 weeks Number of participants represents the Safety Population.	0.40% 3/747 • Number of events 3 • Up to 16 weeks Number of participants represents the Safety Population.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.14% 1/737 • Number of events 1 • Up to 16 weeks Number of participants represents the Safety Population.	0.13% 1/747 • Number of events 1 • Up to 16 weeks Number of participants represents the Safety Population.

Other adverse events

Adverse event data not reported

Additional Information

Senior Director, Clinical Operations

Foamix Pharmaceuticals

Phone: 9089630117

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60