Trial Outcomes & Findings for A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne (NCT NCT02815280)

Last Updated: 2022-01-18

Results Overview

To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

495 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2022-01-18

Participant Flow

The study was conducted at 36 sites in the United States and one site in the Dominican Republic from 11 May 2016 to 13 October 2017.

The study consisted of a varied screening period. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All assessments at screening were done as per the schedule of assessment.

Participant milestones

Participant milestones
Measure	FMX-101, 4% Minocycline Foam Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Vehicle Foam Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
Double-Blind Phase STARTED	333	162
Double-Blind Phase COMPLETED	297	137
Double-Blind Phase NOT COMPLETED	36	25
Open-Label Phase STARTED	256	117
Open-Label Phase COMPLETED	169	73
Open-Label Phase NOT COMPLETED	87	44

Reasons for withdrawal

Reasons for withdrawal
Measure	FMX-101, 4% Minocycline Foam Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Vehicle Foam Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.
Double-Blind Phase Adverse Event	1	1
Double-Blind Phase Lost to Follow-up	10	9
Double-Blind Phase Withdrawal by Subject	20	11
Double-Blind Phase Protocol Violation	2	2
Double-Blind Phase Subject: withdrew consent; non-compliant with visits; moved;lack of efficacy;positive pregnancy test	3	2
Open-Label Phase Adverse Event	2	3
Open-Label Phase Lost to Follow-up	18	9
Open-Label Phase Withdrawal by Subject	33	18
Open-Label Phase Protocol Violation	3	0
Open-Label Phase Administrative	26	12
Open-Label Phase Positive pregnancy test; subject- noncompliance; withdrew consent; lack of efficacy etc.	5	2

Baseline Characteristics

A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FMX-101, 4% Minocycline Foam n=333 Participants Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Vehicle Foam n=162 Participants Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Total n=495 Participants Total of all reporting groups
Age, Continuous	20.5 Years STANDARD_DEVIATION 7.8 • n=5 Participants	20.8 Years STANDARD_DEVIATION 7.9 • n=7 Participants	20.6 Years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	197 Participants n=5 Participants	93 Participants n=7 Participants	290 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	69 Participants n=7 Participants	205 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	127 Participants n=5 Participants	65 Participants n=7 Participants	192 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	206 Participants n=5 Participants	97 Participants n=7 Participants	303 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	73 Participants n=5 Participants	30 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) White	243 Participants n=5 Participants	124 Participants n=7 Participants	367 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	1 Participants n=7 Participants	7 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: Baseline and Week 12

Population: An ITT population: included all randomized participants.

Outcome measures

Outcome measures
Measure	FMX-101, 4% Minocycline Foam n=333 Participants Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Vehicle Foam n=162 Participants Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Open-label-FMX-101, 4% Minocycline Foam Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12	13.78 Lesions Standard Error 0.66	10.64 Lesions Standard Error 0.94	—

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: An ITT population: included all randomized participants.

The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. 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

Outcome measures
Measure	FMX-101, 4% Minocycline Foam n=333 Participants Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Vehicle Foam n=162 Participants Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Open-label-FMX-101, 4% Minocycline Foam Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12	14.66 Percentage of participants	7.89 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: An ITT Population: included all randomized participants.

To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from baseline is calculated as the baseline value minus the post-baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).

Outcome measures

Outcome measures
Measure	FMX-101, 4% Minocycline Foam n=333 Participants Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Vehicle Foam n=162 Participants Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Open-label-FMX-101, 4% Minocycline Foam Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12	26.33 Percent Change Standard Error 2.88	13.49 Percent Change Standard Error 4.66	—

SECONDARY outcome

Timeframe: Baseline, Week 6 and Week 9

Population: An ITT population: included all randomized population.

Outcome measures

Outcome measures
Measure	FMX-101, 4% Minocycline Foam n=333 Participants Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Vehicle Foam n=162 Participants Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Open-label-FMX-101, 4% Minocycline Foam Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9 Week 6	12.90 Lesions Standard Error 0.61	9.01 Lesions Standard Error 0.87	—
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9 Week 9	13.42 Lesions Standard Error 0.66	9.64 Lesions Standard Error 0.94	—

SECONDARY outcome

Timeframe: Baseline, Week 6 and Week 9

Population: An ITT population: included all randomized population.

Outcome measures

Outcome measures
Measure	FMX-101, 4% Minocycline Foam n=333 Participants Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Vehicle Foam n=162 Participants Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Open-label-FMX-101, 4% Minocycline Foam Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9 Week 6	4.68 Percentage of participants	0.81 Percentage of participants	—
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9 Week 9	7.61 Percentage of participants	5.97 Percentage of participants	—

SECONDARY outcome

Timeframe: Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52

Population: Safety population: included all randomized participants who received IP. Participants who had no post-Baseline assessments were included in the Safety population unless all dispensed IP was returned unused.

To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.

Outcome measures

Outcome measures
Measure	FMX-101, 4% Minocycline Foam n=333 Participants Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Vehicle Foam n=162 Participants Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Open-label-FMX-101, 4% Minocycline Foam n=373 Participants Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any TEAE	110 Participants	45 Participants	120 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any Treatment-related TEAE	9 Participants	3 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any Serious TEAE	4 Participants	2 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any TEAE Leading to IP discontinuation	1 Participants	1 Participants	5 Participants

Adverse Events

Double-blind-FMX-101, 4% Minocycline Foam

Serious events: 4 serious events

Other events: 40 other events

Deaths: 0 deaths

Double-blind-Vehicle Foam

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Open-label-FMX-101, 4% Minocycline Foam

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Double-blind-FMX-101, 4% Minocycline Foam n=333 participants at risk Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Double-blind-Vehicle Foam n=162 participants at risk Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Open-label-FMX-101, 4% Minocycline Foam n=373 participants at risk Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.62% 1/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
Hepatobiliary disorders Cholecystitis	0.00% 0/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.62% 1/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
General disorders Intestinal obstruction	0.30% 1/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
General disorders Intestinal perforation	0.30% 1/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
General disorders Fatigue	0.00% 0/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.27% 1/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
Infections and infestations Pneumonia	0.00% 0/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.62% 1/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
Injury, poisoning and procedural complications Facial bones fracture	0.30% 1/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
Injury, poisoning and procedural complications Head injury	0.00% 0/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.27% 1/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.30% 1/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
Respiratory, thoracic and mediastinal disorders Asthma	0.30% 1/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	0.00% 0/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52

Other adverse events

Other adverse events
Measure	Double-blind-FMX-101, 4% Minocycline Foam n=333 participants at risk Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.	Double-blind-Vehicle Foam n=162 participants at risk Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.	Open-label-FMX-101, 4% Minocycline Foam n=373 participants at risk Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.
Infections and infestations Nasopharyngitis	7.2% 24/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	4.3% 7/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	6.2% 23/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
Nervous system disorders Headache	6.3% 21/333 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	5.6% 9/162 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52	4.6% 17/373 • Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52

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: LTE60