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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Docteur MICHEELS
Geneva, Switzerland
Crow's feet responder for the feasibility outcome
The crow's feet responder is defined as a crow's feet score with at least one grade of improvement between D0 and D63. As the subject can be treated on each side, each subject can give two answers.
Time frame: Day 63 (end of study)
Subject satisfaction for acceptability outcome
5-grade Likert scale
Time frame: at Day 0, Day 21, D42 and D63 (end of study visit)
Pain evaluated by the subject
Subjective visual analogue scale (0 to 10 cm)
Time frame: at Day 0, Day 21 and D42
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