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

Aesthetics Clinical Trial

— ECLAH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703740
• Other study ID #: 15F/IALE01
• Status: Completed
• Phase: N/A
• Start date: January 11, 2016
• Est. completion date: February 3, 2017

Study information

• Verified date: October 2019
• Source: Laboratoires Genévrier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 3, 2017
• Est. primary completion date: February 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aesthetics

Intervention

Device:
• Hyaluronic acid dermal filler with lidocaine 0.3%
injection in labial fold of a dermal filler

Locations

Country	Name	City	State
France	CREABIO	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Genévrier

Country where clinical trial is conducted

France, 

Outcome

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