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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEOSYAL® PureSense Redensity [I]/MicronJet® | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEOSYAL® PureSense Redensity [I]/MicronJet® | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 63 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject satisfaction for acceptability outcome | 5-grade Likert scale | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | 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 | at Day 0, Day 21 and D42 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Docteur MICHEELS | Geneva | 1206 | Switzerland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 18, 2016 | |
| Reset | Dec 9, 2016 | |
| Release | May 1, 2017 | |
| Reset | Aug 4, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 18, 2016 | Dec 9, 2016 | |||
| May 1, 2017 |
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| at Day 0, Day 21 and D42 |
| Change from Baseline of crow's feet scale (Aesthetic Improvement) for efficacy Measurement | 7-grade scale | at Day 21, Day 42 and Day 63 (end of study visit) |
| Global Aesthetic Improvement scale for efficacy measurement | 5 grade likert scale | 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 | at Day 63 (end of study visit) |
| Pain sensation at the insertion, in comparison with a classic needle | 4-grade scale | at Day 63 (end of study visit) |
| Aug 4, 2017 |