Acne Vulgaris
Conditions
Brief summary
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)
Detailed description
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments: * FMX101 4% minocycline foam * Vehicle foam
Interventions
DRUGFMX101
FMX101, 4% minocycline foam
DRUGVehicle Foam
Vehicle Foam
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has facial acne vulgaris with: 1. 20 to 50 inflammatory lesions (papules, pustules, and nodules) 2. 25 to 100 non-inflammatory lesions (open and closed comedones) 3. No more than 2 nodules on the face 4. IGA score of moderate (3) to severe (4) 2. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.
Exclusion criteria
1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations. 2. Sunburn on the face.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. | 12 weeks | A decrease in the inflammatory lesion count from Baseline to Week 12. |
| 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 | 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 | 6 weeks |
| The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | 12 weeks |
| 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 | 9 weeks |
| 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 | 6 weeks |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 | 9 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FMX101, 4% Minocycline Foam FMX101, 4% minocycline foam applied topically once daily for 12 weeks
FMX101: FMX101, 4% minocycline foam | 738 |
| Vehicle Foam Vehicle foam applied topically once daily for 12 weeks
Vehicle Foam: Vehicle Foam | 750 |
| Total | 1,488 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal Lab Results | 1 | 0 |
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Lost to Follow-up | 34 | 39 |
| Overall Study | Miscellaneous | 9 | 8 |
| Overall Study | Protocol Violation | 6 | 4 |
| Overall Study | Withdrawal by Subject | 36 | 53 |
Baseline characteristics
| Characteristic | FMX101, 4% Minocycline Foam | Total | Vehicle Foam |
|---|---|---|---|
| Age, Customized 13-17 | 321 Participants | 630 Participants | 309 Participants |
| Age, Customized ≥ 18 | 375 Participants | 775 Participants | 400 Participants |
| Age, Customized 9-12 | 42 Participants | 83 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 266 Participants | 518 Participants | 252 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 472 Participants | 970 Participants | 498 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 54 Participants | 29 Participants |
| Race (NIH/OMB) Black or African American | 125 Participants | 269 Participants | 144 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 24 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 571 Participants | 1131 Participants | 560 Participants |
| Sex: Female, Male Female | 460 Participants | 929 Participants | 469 Participants |
| Sex: Female, Male Male | 278 Participants | 559 Participants | 281 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 737 | 0 / 747 |
| other Total, other adverse events | 0 / 737 | 0 / 747 |
| serious Total, serious adverse events | 1 / 737 | 4 / 747 |
Outcome results
Primary
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
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FMX101, 4% Minocycline 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 |
| 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 | 133 participants |
Primary
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
A decrease in the inflammatory lesion count from Baseline to Week 12.
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| FMX101, 4% Minocycline Foam | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. | 16.39 Lesion Count |
| Vehicle Foam | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. | 12.74 Lesion Count |
Secondary
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
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FMX101, 4% Minocycline 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 |
| 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 | 46 participants |
Secondary
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
Time frame: 9 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FMX101, 4% Minocycline 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 |
| 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 | 79 participants |
Secondary
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6
Time frame: 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| FMX101, 4% Minocycline Foam | The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 | 13.09 Lesion Count |
| Vehicle Foam | The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 | 9.57 Lesion Count |
Secondary
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9
Time frame: 9 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| FMX101, 4% Minocycline Foam | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 | 15.59 Lesion Count |
| Vehicle Foam | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 | 11.72 Lesion Count |
Secondary
The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| FMX101, 4% Minocycline Foam | The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | 18.80 Lesion Count |
| Vehicle Foam | The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | 15.89 Lesion Count |