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