Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Determine the Optimal Dose of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Frankfurt, Deutschland, 60318
- Merz Pharmaceuticals GmbH
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Moderate to severe glabellar frown lines
Exclusion Criteria:
- Previous insertion of permanent material in the glabellar area
- Neuromuscular function disease
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Placebo-Komparator: Placebo
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Single treatment with Placebo given as intramuscular treatment injections of equal amount to 5 sites on Day 0. A volume of reconstituted 0.6 mL per subject was administered.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL Placebo per injection site.
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Experimental: 20 U NT 201
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Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
Andere Namen:
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Experimental: 10 U NT 201
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Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
Andere Namen:
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Experimental: 30 U NT 201
|
Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
Zeitfenster: Baseline (Day 0) to Day 30
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Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1). The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints. |
Baseline (Day 0) to Day 30
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Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale
Zeitfenster: Baseline (Day 0) to Day 30
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Responders will be subjects with at least a 1-point improvement compared to Day 0. The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints. |
Baseline (Day 0) to Day 30
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS
Zeitfenster: Baseline (Day 0) to Day 90
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Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1). Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint. |
Baseline (Day 0) to Day 90
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Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment
Zeitfenster: Baseline (Day 0) to Day 90
|
Responders will be subjects with at least a 1-point improvement compared to Day 0. Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint. |
Baseline (Day 0) to Day 90
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Merz Pharmaceuticals, Merz Pharmaceuticals GmbH
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Agenten des peripheren Nervensystems
- Cholinerge Wirkstoffe
- Membrantransportmodulatoren
- Acetylcholinfreisetzungshemmer
- Neuromuskuläre Wirkstoffe
- Botulinumtoxine
- Botulinumtoxine, Typ A
- AbobotulinumtoxinA
- incobotulinumtoxinA
Andere Studien-ID-Nummern
- MRZ 60201-0527/1
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