Calendario›SNY›NADGL
NADGL
A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)
Ensayo de Sanofi en Facial Wrinkles (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 45
- Centros
- 1
previstos
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en ene 2007.
Qué mide
To evaluate the pain experienced during and after the injection procedure for NADGL as compared to Captique® Injectable Gel in subjects undergoing cutaneous correction of nasolabial folds (NLFs). (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this research study is to compare subject comfort during and after injection with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield, NJ). NADGL is a new product (not FDA approved) with lidocaine and is also manufactured by Genzyme Biosurgery. We do not know which of these treatments results in less pain during and after injection. The safety of NADGL is also being studied.
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Ficha completa en ClinicalTrials.gov (NCT00417469), actualizada en mar 2015.