NCT02297503

Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster

An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure Alone or Restylane/Emervel Filler Alone

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 35 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.

Conditions

• Facial Aesthetic Treatment

Interventions

Type	Name	Description
DRUG	Azzalure	Glabellar lines
DEVICE	Restylane/Emervel filler	Facial tissue augmentation
DEVICE	Restylane Skinbooster	Facial skin rejuvenation

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-11-21
• Last updated: 2022-08-26
• Results posted: 2019-09-23

Locations

3 sites across 2 countries: France, Sweden