TEOSYAL® PureSense Redensity [I] Injection Using MicronJet® Needle in the Treatment of Crow's Feet Wrinkles
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|ClinicalTrials.gov Identifier: NCT02497846|
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : April 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Crow's Feet Wrinkles||Device: TEOSYAL® PureSense Redensity [I]/MicronJet®||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Acceptability of a TEOSYAL® PureSense Redensity [I] Injection Using MicronJet® Needle in the Treatment of Crow's Feet Wrinkles|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: TEOSYAL® PureSense Redensity [I]/MicronJet®
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:
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 [ Time Frame: Day 63 (end of study) ]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.
- Subject satisfaction for acceptability outcome [ Time Frame: at Day 0, Day 21, D42 and D63 (end of study visit) ]5-grade Likert scale
- Pain evaluated by the subject [ Time Frame: at Day 0, Day 21 and D42 ]Subjective visual analogue scale (0 to 10 cm)
- Adverse event [ Time Frame: From Day 0 to Day 63 (end of study) ]
- Local reactions collected by the subject [ Time Frame: at Day 0, Day 21 and D42 ]Local reactions collected by the subject on a 14-day subject diary
- Change from Baseline of crow's feet scale (Aesthetic Improvement) for efficacy Measurement [ Time Frame: at Day 21, Day 42 and Day 63 (end of study visit) ]7-grade scale
- Global Aesthetic Improvement scale for efficacy measurement [ Time Frame: at Day 21, Day 42 and Day 63 (end of study visit) ]5 grade likert scale
- Product leakage at the skin area, in comparison with a classic needle [ Time Frame: at Day 63 (end of study visit) ]4-grade scale
- Pain sensation at the insertion, in comparison with a classic needle [ Time Frame: at Day 63 (end of study visit) ]4-grade scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497846
|Geneva, Switzerland, 1206|