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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Frankfurt, Tyskland, 60318
- Merz Pharmaceuticals GmbH
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Moderate to severe glabellar frown lines
Exclusion Criteria:
- Previous insertion of permanent material in the glabellar area
- Neuromuscular function disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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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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Eksperimentel: 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.
Andre navne:
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Eksperimentel: 10 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.
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS
Tidsramme: 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
Tidsramme: Baseline (Day 0) to Day 90
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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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Merz Pharmaceuticals, Merz Pharmaceuticals GmbH
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Membrantransportmodulatorer
- Acetylcholin-frigivelseshæmmere
- Neuromuskulære midler
- Botulinum toksiner
- Botulinumtoksiner, type A
- abobotulinumtoxinA
- incobotulinumtoxinA
Andre undersøgelses-id-numre
- MRZ 60201-0527/1
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