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This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMX-101, 4% minocycline foam | Experimental | FMX-101, 4% minocycline foam applied topically once daily for 12 weeks |
|
| Vehicle Foam | Placebo Comparator | Vehicle foam applied topically once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMX-101, 4% minocycline foam | Drug | FMX-101, 4% minocycline foam applied topically once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12 | 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. | Baseline and Week 12 |
| Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12 | 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | 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). |
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Inclusion Criteria:
Has facial acne vulgaris with:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | Arizona | 85308 | United States | |||
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | FMX-101, 4% Minocycline Foam | Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed. |
| FG001 | Vehicle Foam | Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2016 | Oct 21, 2020 |
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| Vehicle Foam | Drug | Vehicle foam applied topically once daily for 12 weeks |
|
| Baseline and Week 12 |
| Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9 | 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. | Baseline, Week 6 and Week 9 |
| Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9 | 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. | Baseline, Week 6 and Week 9 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | 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. | Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52 |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Oceanside | California | 92049 | United States |
| Denver | Colorado | 80220 | United States |
| Hialeah | Florida | 33016 | United States |
| Miami | Florida | 33126 | United States |
| Miami | Florida | 33175 | United States |
| Sweetwater | Florida | 33172 | United States |
| Marietta | Georgia | 30060 | United States |
| Snellville | Georgia | 30078 | United States |
| Chicago | Illinois | 60611 | United States |
| Carmel | Indiana | 46032 | United States |
| Indianapolis | Indiana | 46256 | United States |
| Overland Park | Kansas | 66215 | United States |
| Owensboro | Kentucky | 42303 | United States |
| Crowley | Louisiana | 70526 | United States |
| Clarkston | Michigan | 48346 | United States |
| Detroit | Michigan | 48202 | United States |
| Montclair | New Jersey | 07042 | United States |
| Verona | New Jersey | 07044 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| New York | New York | 10022 | United States |
| The Bronx | New York | 10458 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Cleveland | Ohio | 44121 | United States |
| Hazleton | Pennsylvania | 18201 | United States |
| Chattanooga | Tennessee | 37421 | United States |
| Goodlettsville | Tennessee | 37072 | United States |
| Austin | Texas | 78746 | United States |
| New Braunfels | Texas | 78130 | United States |
| Port Arthur | Texas | 77640 | United States |
| San Antonio | Texas | 78229 | United States |
| Sugar Land | Texas | 77479 | United States |
| Salt Lake City | Utah | 84117 | United States |
| Seattle | Washington | 98104 | United States |
| Santo Domingo | Dominican Republic |
| COMPLETED |
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| NOT COMPLETED |
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| Open-Label Phase |
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Double-blind participants (Intent-to-Treat population [ITT]) were moved to open-label (safety population). An ITT population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | FMX-101, 4% Minocycline Foam | Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed. |
| BG001 | Vehicle Foam | Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12 | 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. | An ITT population: included all randomized participants. | Posted | Least Squares Mean | Standard Error | Lesions | Baseline and Week 12 |
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| Primary | Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12 | 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. | An ITT population: included all randomized participants. | Posted | Number | Percentage of participants | Baseline and Week 12 |
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| Secondary | Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | 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). | An ITT Population: included all randomized participants. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline and Week 12 |
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| Secondary | Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9 | 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. | An ITT population: included all randomized population. | Posted | Least Squares Mean | Standard Error | Lesions | Baseline, Week 6 and Week 9 |
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| Secondary | Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9 | 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. | An ITT population: included all randomized population. | Posted | Number | Percentage of participants | Baseline, Week 6 and Week 9 |
|
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | 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. | 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. | Posted | Count of Participants | Participants | Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52 |
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Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-blind-FMX-101, 4% Minocycline Foam | Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed. | 0 | 333 | 4 | 333 | 40 | 333 |
| EG001 | Double-blind-Vehicle Foam | Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed. | 0 | 162 | 2 | 162 | 15 | 162 |
| EG002 | 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. | 0 | 373 | 1 | 373 | 38 | 373 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | General disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Intestinal perforation | General disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
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| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 19.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iain Stuart, PhD. | Foamix Pharmaceuticals, Inc. | 1 800-775-7936 | Iain.Stuart@foamix.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2017 | Oct 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Withdrawal by Subject |
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| Protocol Violation |
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| Administrative |
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| Positive pregnancy test; subject- noncompliance; withdrew consent; lack of efficacy etc. |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 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. |
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