NCT01151436

Brief Summary

The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
2 countries

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 7, 2012

Completed
Last Updated

March 10, 2021

Status Verified

May 1, 2012

Enrollment Period

8 months

First QC Date

June 24, 2010

Results QC Date

April 10, 2012

Last Update Submit

February 16, 2021

Conditions

Facial Wrinkles

Keywords

Facial wrinkle correction

Outcome Measures

Primary Outcomes (3)

  • Full Face Global Aesthetic Improvement

    Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved

    3 weeks after last injection

  • Full Face Global Aesthetic Improvement

    Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved

    3 months after last injection

  • Full Face Global Aesthetic Improvement

    Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved

    6 months after last injection

Secondary Outcomes (24)

  • NASOLABIAL FOLDS SEVERITY ASSESSMENT

    baseline

  • NASOLABIAL FOLDS SEVERITY ASSESSMENT

    3 weeks after last injection

  • NASOLABIAL FOLDS SEVERITY ASSESSMENT

    3 months after last injection

  • NASOLABIAL FOLDS SEVERITY ASSESSMENT

    6 months after last injection

  • PERIORBITAL LINES SEVERITY ASSESSMENT

    baseline

  • +19 more secondary outcomes

Study Arms (1)

hyaluronic acid

EXPERIMENTAL
Device: hyaluronic acid dermal fillers

Interventions

hyaluronic acid dermal fillersDEVICE

1 injection per indication and 1 touch-up injection if necessary

Also known as: Facial wrinkles
hyaluronic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seeking tissue augmentation treatment on the face,
  • Presenting a score of 3 (Moderately deep wrinkle)or 4 (Deep wrinkle) on the Lemperle Rating Scale (LRS) of both nasolabial folds.

You may not qualify if:

  • At risk in term of precautions, warnings and contra-indication referred in the package insert of the study devices,
  • Who underwent previous injection of permanent filler in the injected area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Galderma investigational site

Arras, France

Location

Galderma investigational site

Nice, France

Location

Galderma investigational site

Paris, France

Location

Galderma investigational site

Berlin, Germany

Location

Galderma investigational site

Darmstadt, Germany

Location

Results Point of Contact

Title
Ma May
Organization
Galderma
may.ma@galderma.com
+33 4 92 38 67 33

Study Officials

  • Philippe KESTEMONT

    Investigational site Nice France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2010

First Posted

June 28, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2010

Study Completion

February 1, 2011

Last Updated

March 10, 2021

Results First Posted

May 7, 2012

Record last verified: 2012-05

Locations

FR(3)DE(2)