CClinicalTrials.gg
CompletedNCT02497846Updated Apr 8, 2016

TEOSYAL® PureSense Redensity [I] Injection Using MicronJet® Needle in the Treatment of Crow's Feet Wrinkles

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

Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
25 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Crow's Feet Wrinkles

Keywords

  • Hyaluronic acid
  • MiconJet needle
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteer (desiring an aesthetic improvement of crow's feet area).
  • Crow's feet score between 3 to 5 on both sides.
  • Psychologically able to understand the study related information (For example, it will be difficult to include a foreigner who does not speak French, unaccompanied by a translator or subject who can't read the information note and the volunteer diary).
  • Having given his informed consent.
  • Female subjects of childbearing potential should use a medically accepted contraceptive regimen (for example, hormonal contraception, intrauterine contraceptive device or surgical sterilization...), during all the study and at least 1 month after the study end.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing woman or planning a pregnancy during the study (according to the product IFU).
  • Volunteer having a previous history of cutaneous cancer or all others type of cancer. (to verify that the volunteer is healthy)
  • Suffering from a serious or progressive diseases, which, put the subject at undue risk (as for example diabetes, auto-immune pathology, cardiac pathologies, hepatic deficiency, epilepsy )(to verify that the volunteer is healthy)
  • With scars, infection, or other pathology on the injection sites. (as rosacea, herpes, acne, blotches on the injection sites. (the product injection can't be performed on a damaged skin and the wrinkles can be seen by the investigator - according to the product IFU)
  • With active skin disease within 6 months prior to study entry. (according to the product IFU)
  • With severe rheumatism fever.
  • Predisposed to keloidosis (itchy skin or skin rash and hives) or hypertrophic scarring. (
  • With a known allergy to one of the ingredients of the tested products (as hyaluronic acid hypersensitivity or lidocaine or local anesthetic: 70° Alcohol or Chlorhexidine allergy). (according to the product IFU)
  • With multiple allergies or anaphylactic shock history. (according to the product IFU)
  • With coagulation troubles, abnormal bleeding as hemophiliac or von Willebrand disease.
  • Under an anti-coagulant treatment in the 2 weeks preceding the study.
  • Under >30,000 IU/day oral vitamin E in the 1 week preceding the study.
  • Under corticosteroids in the 2 weeks preceding the study and used in the severe allergy treatment.
  • Under interferon in the 1 month preceding the study and used for antiinfectious or antioncogene proprieties.
  • Having an aspirin (ASA - Acetyl Salicylic Acid) or a non-steroidal anti-inflammatory treatment in the last 15 days (the subject can still be bled easily).
  • Having a peeling, laser or ultrasound-based treatment. (according to the product IFU)
  • Having any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety tolerance (currently, the interactions with an other HA product are not tested, it is not possible to inject Teosyal® PureSense Redensity I into sites where other filling implants are present - according to the product IFU).
  • Suspected to be non-compliant according to the investigator's judgment (for example, a subject for which the investigator knows that he cannot come to all the visits in reason of holidays or moving, can be not include in this study)
  • Enrolled in another clinical trial or being in an exclusion period for a previous study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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: * 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®

Interventions

  • DeviceTEOSYAL® 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.

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. Subject satisfaction for acceptability outcome

    5-grade Likert scale

    Time frame: at Day 0, Day 21, D42 and D63 (end of study visit)

  2. Pain evaluated by the subject

    Subjective visual analogue scale (0 to 10 cm)

    Time frame: at Day 0, Day 21 and D42

Other outcomes

  1. Adverse event

    Time frame: From Day 0 to Day 63 (end of study)

  2. 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

  3. 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)

  4. 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)

  5. Product leakage at the skin area, in comparison with a classic needle

    4-grade scale

    Time frame: at Day 63 (end of study visit)

  6. Pain sensation at the insertion, in comparison with a classic needle

    4-grade scale

    Time frame: at Day 63 (end of study visit)

07

Study locations

1 site
  • Docteur MICHEELS
    Geneva, 1206, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02497846
Lead sponsor
Teoxane SA
Responsible party
Sponsor
First posted
Jul 15, 2015
Start date
May 2015
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Apr 8, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion