A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
13. januar 2022 opdateret af: Vyne Therapeutics Inc.
A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
466
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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San Cristobal, Dominikanske republik
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
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California
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Fremont, California, Forenede Stater, 94538
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Fullerton, California, Forenede Stater, 92835
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Connecticut
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Shelton, Connecticut, Forenede Stater, 06484
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20037
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Florida
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Boynton Beach, Florida, Forenede Stater, 33437
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Miami, Florida, Forenede Stater, 33015
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Miami, Florida, Forenede Stater, 33174
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Miramar, Florida, Forenede Stater, 33027
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Sanford, Florida, Forenede Stater, 32771
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Georgia
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Savannah, Georgia, Forenede Stater, 31406
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Illinois
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Oakbrook Terrace, Illinois, Forenede Stater, 60181
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Indiana
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Evansville, Indiana, Forenede Stater, 47713
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70006
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Maryland
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Rockville, Maryland, Forenede Stater, 20850
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Michigan
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Bay City, Michigan, Forenede Stater, 48706
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89117
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New York
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New York, New York, Forenede Stater, 10075
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New York, New York, Forenede Stater, 10012
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North Carolina
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High Point, North Carolina, Forenede Stater, 27262
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Ohio
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Columbus, Ohio, Forenede Stater, 43213
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Oregon
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Gresham, Oregon, Forenede Stater, 97030
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Rhode Island
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Johnston, Rhode Island, Forenede Stater, 02919
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Tennessee
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Murfreesboro, Tennessee, Forenede Stater, 37130
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Texas
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Dallas, Texas, Forenede Stater, 75234
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Plano, Texas, Forenede Stater, 75024
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San Antonio, Texas, Forenede Stater, 78229
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Utah
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West Jordan, Utah, Forenede Stater, 84088
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West Virginia
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Bridgeport, West Virginia, Forenede Stater, 26330
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
9 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Has facial acne vulgaris with:
- 20 to 50 inflammatory lesions (papules, pustules, and nodules);
- 25 to 100 noninflammatory lesions (open and closed comedones);
- no more than 2 nodules on the face; and
- IGA score of moderate (3) to severe (4)
- 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:
- 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
- Sunburn on the face
- Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
- Abnormal baseline laboratory values that are considered clinically significant
- Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
- Pseudomembranous colitis or antibiotic-associated colitis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: FMX-101, 4% minocycline foam
Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed
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FMX-101, 4% minocyclinskum påført topisk én gang dagligt i 12 uger
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Placebo komparator: Vehicle foam
Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed
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Køretøjsskum påført topisk én gang dagligt i 12 uger
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Absolut ændring fra baseline i antallet af inflammatoriske læsioner i uge 12
Tidsramme: Baseline og uge 12
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For at evaluere effektiviteten i behandlingen af acne sammenlignet med vehikel af topisk FMX101 4% administreret dagligt i 12 uger.
Ændringer fra baseline beregnes som basislinjeværdi minus post-baselineværdi, således at fald vises som positive værdier.
Antal inflammatoriske læsioner inkluderede: papler, pustler og knuder.
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Baseline og uge 12
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Procentdel af deltagere, der opnår Investigator's Global Assessments (IGA) behandlingssucces i uge 12
Tidsramme: Baseline og uge 12
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IGA-skalaen for acne vulgaris blev brugt af efterforskerne til at vurdere sværhedsgraden af en deltagers acne vulgaris.
Skalaen går fra 0 (Klar): normal, klar hud uden tegn på acne vulgaris til 5 (Meget Alvorlig): stærkt inflammatoriske læsioner dominerer, variabelt antal komedoner, mange papler/pustler og mange nodulocystiske læsioner.
Højere score indikerede alvorlige udfald.
Behandlingssucces blev defineret som en IGA-score på 0 (score for clear) eller 1 (næsten klar) og mindst en 2-grads forbedring (reduktion) fra baseline.
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Baseline og uge 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Tidsramme: Baseline and Week 12
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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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Baseline and Week 12
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Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9
Tidsramme: Baseline, at Week 6 and at Week 9
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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.
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Baseline, at Week 6 and at Week 9
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Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
Tidsramme: Baseline, at Week 6 and at Week 9
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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.
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Baseline, at Week 6 and at Week 9
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)
Tidsramme: Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52
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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.
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Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2016
Primær færdiggørelse (Faktiske)
13. oktober 2017
Studieafslutning (Faktiske)
13. oktober 2017
Datoer for studieregistrering
Først indsendt
24. maj 2016
Først indsendt, der opfyldte QC-kriterier
23. juni 2016
Først opslået (Skøn)
28. juni 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FX2014-04
Plan for individuelle deltagerdata (IPD)
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