Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds

NCT ID: NCT02703740

Last Updated: 2019-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-11

Study Completion Date

2017-02-03

Brief Summary

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This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).

Detailed Description

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Interventional, monocentric, double blind, randomised study Evaluation of safety the 1st month (primary criteria) and until 12 month Evaluation of performance at baseline, month 3, month 6, month 9 and month 12 : WSRS (wrinkle scale), profilometry (image measuring wrinkle depth and area), GAIS : satisfaction scale

Conditions

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Aesthetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HA 20 mg/mL

Group Type EXPERIMENTAL

Hyaluronic acid dermal filler with lidocaine 0.3%

Intervention Type DEVICE

injection in labial fold of a dermal filler

HA 24 mg/mL

Group Type EXPERIMENTAL

Hyaluronic acid dermal filler with lidocaine 0.3%

Intervention Type DEVICE

injection in labial fold of a dermal filler

Interventions

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Hyaluronic acid dermal filler with lidocaine 0.3%

injection in labial fold of a dermal filler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is at least 19 years of age.
* Has Fitzpatrick Skin Type IV, V, or VI.
* Has a WSRS score \> or = to 3 for both NLF
* Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months

Exclusion Criteria

Has keloid formation, or hypertrophic scarring or dyschromic scaring. Has hypersensitivity to hyaluronic acid, Chlorhexidine lidocaine or local anaesthetic drugs

* Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
* Has nasolabial folds that are too severe to be corrected in one treatment session.
* Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold during the last year.
* Is pregnant, lactating, or not using acceptable contraception.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratoires Genévrier

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CREABIO

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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15F/IALE01

Identifier Type: -

Identifier Source: org_study_id

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