NCT01412190

Study to Evaluate Restylane Vital Light Using an Injector Device

An Open, Randomized, Single-centre, Intra-individual Controlled, Explorative, Safety and Efficacy Study Comparing Restylane Vital White With no Treatment in the Face, Back of the Hands and décolletage, Using an Injector Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety and efficacy of Restylane Vital White administered with an injector device on aged skin in the face, hands and décolletage.

Detailed description

The objectives are to explore the safety and efficacy profile of Restylane Vital White administered with an injector device when one side of the face, one of the hands and one side of the décolletage is treated and the other side of the face, the other hand and the other side of the décolletage is left untreated. The face, the hands and the décolletage will be evaluated separately for both the efficacy and the safety parameters.

Conditions

• Aesthetics

Interventions

Type	Name	Description
DEVICE	Restylane Vital Light	Treatment of up to 4 ml for one side of the face, one hand and one side of the décolletage dispensed by 10ul doses 0.5-1 cm apart. 3 treatment sessions 4 weeks apart.
OTHER	No treatment	One side of face, one hand and one side of the décolletage is left untreated as a control.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2011-08-09
• Last updated: 2022-08-25

Locations

1 site across 1 country: Germany