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Clinical Trials/NCT02703740
NCT02703740CompletedNot Applicable

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

Laboratoires Genévrier1 site in 1 country60 target enrollmentStarted: January 11, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Number and description of adverse events that are related to treatment

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

HA 20 mg/mL

Experimental

Intervention: Hyaluronic acid dermal filler with lidocaine 0.3% (Device)

HA 24 mg/mL

Experimental

Intervention: Hyaluronic acid dermal filler with lidocaine 0.3% (Device)

Outcomes

Primary Outcomes

Number and description of adverse events that are related to treatment

Time Frame: 1 month

Secondary Outcomes

  • 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(1/3/6/9/12 months)

Investigators

Sponsor
Laboratoires Genévrier
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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