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

NCT02497846 | Completed Phase 4

• 1 other identifier: TEO-R1-1404
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crow's Feet Wrinkles

Keywords

Hyaluronic acid; MiconJet needle

Outcome Measures

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.

  Day 63 (end of study)

Secondary Outcomes (2)

• Subject satisfaction for acceptability outcome

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

• Pain evaluated by the subject

  at Day 0, Day 21 and D42

Other Outcomes (6)

• Adverse event

  From Day 0 to Day 63 (end of study)

• Local reactions collected by the subject

  at Day 0, Day 21 and D42

• Change from Baseline of crow's feet scale (Aesthetic Improvement) for efficacy Measurement

  at Day 21, Day 42 and Day 63 (end of study visit)

Study Arms (1)

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: * 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

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.

TEOSYAL® PureSense Redensity [I]/MicronJet®

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Teoxane SA: lead

Study Sites (1)

Docteur MICHEELS

Geneva, 1206, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: July 15, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 8, 2016

Record last verified: 2015-05

Locations

CH (1)