IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines.
J Drugs Dermatol
; 19(10): 985-991, 2020 10 01.
Article
en En
| MEDLINE
| ID: mdl-33026771
ABSTRACT
BACKGROUND:
Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy. A 2-stage Phase 2, randomized, double-blind study investigated the duration of effect and safety of IncobotulinumtoxinA (INCO; Xeomin®, Bocouture®; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) at doses higher than the approved 20 units (U) for glabellar frown lines (GFL). Primary safety and efficacy endpoints of Stage 1 are reported here.METHODS:
151 subjects with moderate-to-severe GFL were randomized 122 to receive a single treatment with 20U, 50U, or 75U INCO. The primary efficacy endpoint was median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale.RESULTS:
The median duration of effect was 185 days for the 50U dose group (95% CI[182, 205]) and 210 days for the 75U dose group (95% CI[182, 217]). Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups. Duration of effect was also longer for 50U vs 20U, however; statistical significance was not reached (P=0.4349). The incidence of treatment-related adverse events was low across all doses (20U2[6.7%], 50U6[10.0%] and 75U8[13.1%]).CONCLUSIONS:
These results demonstrate a dose effect of at least 6 months duration with higher doses in the majority of GFL subjects. All doses were well tolerated and safety was consistent with the known safety profile of 20U INCO for GFL. J Drugs Dermatol. 2020;19(10)985-991. doi10.36849/JDD.2020.5454.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Envejecimiento de la Piel
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Técnicas Cosméticas
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Toxinas Botulínicas Tipo A
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Fármacos Neuromusculares
Tipo de estudio:
Clinical_trials
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Observational_studies
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Risk_factors_studies
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Drugs Dermatol
Asunto de la revista:
DERMATOLOGIA
Año:
2020
Tipo del documento:
Article