NCT02703740

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2017

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

January 18, 2016

Last Update Submit

October 10, 2019

Conditions

Aesthetics

Outcome Measures

Primary Outcomes (1)

  • Number and description of adverse events that are related to treatment

    1 month

Secondary Outcomes (2)

  • 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

Study Arms (2)

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

Hyaluronic acid dermal filler with lidocaine 0.3%DEVICE

injection in labial fold of a dermal filler

HA 20 mg/mLHA 24 mg/mL

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CREABIO

Lyon, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

March 9, 2016

Study Start

January 11, 2016

Primary Completion

February 3, 2017

Study Completion

February 3, 2017

Last Updated

October 14, 2019

Record last verified: 2019-10

Locations

FR(1)