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OpenTrials
Completed

NCT Number: NCT02703740

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

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).

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Key information

Conditions

Aesthetics

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CREABIO

Lyon, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic acid dermal filler with lidocaine 0.3%

Device

injection in labial fold of a dermal filler

Primary outcomes

  1. Number and description of adverse events that are related to treatment

    Time frame: 1 month

Secondary outcomes

  1. Number and description of adverse events that are related to treatment

    Time frame: 72h/3 months/6 Months/9 months/12 months

  2. Treatment efficacy assessed by WSRS

    Time frame: 1/3/6/9/12 months

    WSRS (wrinkle severity rating scale) : a 5-point validated scale ranging from 1 (absent) to 5 (extreme).

Sponsors and collaborators

Lead sponsor

Laboratoires Genévrier

Industry

Registry information

Acronym: ECLAH

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2016
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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