Long Term Safety and Efficacy Assessment of Hyaluronic Ac... | NCT02703740

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

NCT02703740

Sponsor

Laboratoires Genévrier

Status

Completed

Last Update Posted

Oct 14, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Aesthetics

Interventions

Hyaluronic acid dermal filler with lidocaine 0.3%

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2016Actual

Primary Completion Date

Feb 3, 2017Actual

Completion Date

Feb 3, 2017Actual

First Submitted Date

Jan 18, 2016

First Submission Date that Met QC Criteria

Mar 3, 2016

First Posted Date

Mar 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2019

Last Update Posted Date

Oct 14, 2019Actual

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HA 20 mg/mL	Experimental		Device: Hyaluronic acid dermal filler with lidocaine 0.3%
HA 24 mg/mL	Experimental		Device: Hyaluronic acid dermal filler with lidocaine 0.3%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronic acid dermal filler with lidocaine 0.3%	Device	injection in labial fold of a dermal filler	HA 20 mg/mL HA 24 mg/mL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and description of adverse events that are related to treatment		1 month

Secondary Outcomes

Measure	Description	Time Frame
Number and description of adverse events that are related to treatment		72h/3 months/6 Months/9 months/12 months
Treatment efficacy assessed by WSRS	WSRS (wrinkle severity rating scale) : a 5-point validated scale ranging from 1 (absent) to 5 (extreme).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided