A Phase 4 interventional study of TEOSYAL® PureSense Redensity [I]/MicronJet® in Crow's Feet Wrinkles, sponsored by Teoxane SA. Completed at 1 site in Switzerland. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-08.
Sponsored by Teoxane SA · Phase 4, Interventional, and Treatment
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.
Teoxane SA is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
injection of the acid hyaluronic gel with lidocaine as an anesthetic and a "dermo-restructuring complex (including 8 amino acids , 3 antioxidants Acid, vitamin B6 and 2 minerals). Product will be injected in a unique device group: * in crow's feet in order to cover the zone to be treated. Quantity of product injected will be determined by the injector and noted (up to 1 ml by side). A subject can be injected in the left or/and right side. * using a MicronJet microneedle for the superficial wrinkles.
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.
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
Adverse event
Time frame: From Day 0 to Day 63 (end of study)
Local reactions collected by the subject
Local reactions collected by the subject on a 14-day subject diary
Time frame: at Day 0, Day 21 and D42
Change from Baseline of crow's feet scale (Aesthetic Improvement) for efficacy Measurement
7-grade scale
Time frame: at Day 21, Day 42 and Day 63 (end of study visit)
Global Aesthetic Improvement scale for efficacy measurement
5 grade likert scale
Time frame: at Day 21, Day 42 and Day 63 (end of study visit)
Product leakage at the skin area, in comparison with a classic needle
4-grade scale
Time frame: at Day 63 (end of study visit)
Pain sensation at the insertion, in comparison with a classic needle
4-grade scale
Time frame: at Day 63 (end of study visit)
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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