NCT02497846

TEOSYAL® PureSense Redensity [I] Injection Using MicronJet® Needle in the Treatment of Crow's Feet Wrinkles

Feasibility and Acceptability of a TEOSYAL® PureSense Redensity [I] Injection Using MicronJet® Needle in the Treatment of Crow's Feet Wrinkles

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Teoxane SA · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the feasibility and acceptability of a TEOSYAL® PureSense Redensity \[I\] injection using MicronJet® needle in the treatment of crow's feet wrinkles. It is a monocentric, open-blind, prospective, pilot study. 3 injections sessions spaced with an interval of 3 weeks. The last visit will be performed 3 weeks after the last injection. Only, one group of 15 healthy volunteers will be included.

Detailed description

TEOSYAL® PureSense Redensity \[I\] is a viscoelastic gel of non-cross-linked hyaluronic acid that is sterile, non pyrogenic, colourless and of non-animal origin and contains 0.3% by mass of lidocaine hydrochloride, for its anaesthetic properties. Each box contains two syringes pre-filled with Teosyal® PureSense Redensity I. The volume of each syringe is shown on the cardboard box as well as on each syringe. Teosyal® PureSense Redensity I is indicated for the prevention of wrinkles and rehydration of the neck, neckline, face and in particular the crow's feet wrinkles. The MicronJet® needle is a 3 micro-needle (0.6 mm of length) device that is mounted on a standard syringe in the same manner as a conventional needle. The MicronJet® needle is used to inject liquid substances, allowing for controlled intradermal delivery in any procedure which requires administration of substances to the dermal compartment. For the first time, the TEOSYAL® PureSense Redensity \[I\] will be injected using the medical device MicronJet® in the superficial wrinkles.

Conditions

• Crow's Feet Wrinkles

Interventions

Type	Name	Description
DEVICE	TEOSYAL® PureSense Redensity [I]/MicronJet®	According the instruction of use, 3 injections of TEOSYAL® PureSense Redensity \[I\]will be performed all the 3 weeks. The used needle will be the MicronJet® microneedles for product injection. And the last visit (of control) will be performed 3 weeks after the last injection.

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-07-15
• Last updated: 2016-04-08

Locations

1 site across 1 country: Switzerland