Facial WrinklesFRESHNCT01151436

Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers

A study testing hyaluronic acid dermal fillers in people with Facial Wrinkles, run by Galderma R&D at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Facial Wrinkles
What is being tested?: hyaluronic acid dermal fillers
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 5 sitesin 2 countries
Study dates: Mar 2010to Feb 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

France3 sites

Galderma investigational site
Arras
Galderma investigational site
Nice
Galderma investigational site
Paris

Other trials in France

Germany2 sites

Galderma investigational site
Berlin
Galderma investigational site
Darmstadt

Other trials in Germany

About this study

Official title: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction

Read the detailed description

The range of fillers tested in this study includes 5 different hyaluronic acid dermal fillers: Emervel Touch, Emervel Classic, Emervel Deep, Emervel Volume and Emervel Lips.

The study will last 6 month.

Injections will be performed at baseline. If necessary, the investigator will perform touch-up injections at the following visit (3 weeks later).

Investigator and subject satisfaction will be collected through questionnaires.

Conditions: Facial Wrinkles
Being tested: hyaluronic acid dermal fillers
Keywords: Facial wrinkle correction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

hyaluronic acid dermal fillersDevice
Also called Facial wrinkles
1 injection per indication and 1 touch-up injection if necessary

Study groups in NCT01151436
Study group	Role	What they receive
hyaluronic acid	Experimental	Not described Receives: Device: hyaluronic acid dermal fillers

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 6 months after last injection

Secondary outcomes (24)

NASOLABIAL FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: baseline
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 weeks after last injection
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 months after last injection
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 6 months after last injection
PERIORBITAL LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: baseline
PERIORBITAL LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 weeks after last injection
PERIORBITAL LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 MONTHS AFTER LAST INJECTION
PERIORBITAL LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 6 MONTHS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: BASELINE
MARIONETTE LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 WEEKS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 MONTHS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 6 MONTHS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: BASELINE
UPPER LIP LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 WEEKS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 MONTHS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 6 MONTHS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: BASELINE
CHEEK FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 WEEKS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 3 MONTHS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale:
0: no wrinkles
1. just perceptible wrinkle
2. shallow wrinkle
3. moderately deep wrinkle
4. deep wrinkle, well-defined edges
5. very deep wrinkle redundant fold
Measured: 6 MONTHS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Lip fullness grading scale score:
0: very thin lip
1. thin lip
2. moderately thick lip
3. thick lip
4. full lip
Measured: baseline
LIP ENHANCEMENT ASSESSMENT
Lip fullness grading scale score:
0: very thin lip
1. thin lip
2. moderately thick lip
3. thick lip
4. full lip
Measured: 3 WEEKS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Lip fullness grading scale score:
0: very thin lip
1. thin lip
2. moderately thick lip
3. thick lip
4. full lip
Measured: 3 MONTHS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Lip fullness grading scale score:
0: very thin lip
1. thin lip
2. moderately thick lip
3. thick lip
4. full lip
Measured: 6 MONTHS AFTER LAST INJECTION

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Feb 2011

First posted28 Jun 2010 (estimated)
Study startMar 2010
Primary completionNov 2010
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Facial WrinklesStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01151436
Sponsor's protocol ID: RD.03.CIP.29089
Other IDs: 2009-018163-28, 2009
Acronym: FRESH
Status last verified: May 2012
First submitted: 24 Jun 2010
Last updated: 10 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of MD60002 Device for Facial Skin Aging
Facial Wrinkles, Skin Aging
Recruiting
Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality
Photoaged Facial Skin, Photoaging
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Antioxidant Nutrition and Facial Exercise for Skin Aging
Facial Skin Aging and Wrinkle Severity
Not yet recruitingObservational study
Comparing Facial Aging Between Identical Twins With 3D Imaging
Facial Skin Aging, Facial Volume Loss
Not yet recruiting
Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
Facial Wrinkles, Jawline Contour

All Facial Wrinkles trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction
ClinicalTrials.gov ID: NCT01151436
Acronym / sponsor ID: FRESH / RD.03.CIP.29089
Conditions: Facial Wrinkles
Keywords: Facial wrinkle correction
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Nov 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 28 Jun 2010 (estimated)
Results: Posted 7 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The range of fillers tested in this study includes 5 different hyaluronic acid dermal fillers: Emervel Touch, Emervel Classic, Emervel Deep, Emervel Volume and Emervel Lips.

The study will last 6 month.

Injections will be performed at baseline. If necessary, the investigator will perform touch-up injections at the following visit (3 weeks later).

Investigator and subject satisfaction will be collected through questionnaires.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
hyaluronic acid	Experimental	Device: hyaluronic acid dermal fillers

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
hyaluronic acid dermal fillersAlso: Facial wrinkles1 injection per indication and 1 touch-up injection if necessary	Device	hyaluronic acid

Primary outcome

Full Face Global Aesthetic Improvement
Time frame: 3 weeks after last injection
Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved
Full Face Global Aesthetic Improvement
Time frame: 3 months after last injection
Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved
Full Face Global Aesthetic Improvement
Time frame: 6 months after last injection
Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved

24 secondary outcomes

NASOLABIAL FOLDS SEVERITY ASSESSMENT
Time frame: baseline
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Time frame: 3 weeks after last injection
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Time frame: 3 months after last injection
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Time frame: 6 months after last injection
PERIORBITAL LINES SEVERITY ASSESSMENT
Time frame: baseline
PERIORBITAL LINES SEVERITY ASSESSMENT
Time frame: 3 weeks after last injection
PERIORBITAL LINES SEVERITY ASSESSMENT
Time frame: 3 MONTHS AFTER LAST INJECTION
PERIORBITAL LINES SEVERITY ASSESSMENT
Time frame: 6 MONTHS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Time frame: BASELINE
MARIONETTE LINES SEVERITY ASSESSMENT
Time frame: 3 WEEKS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Time frame: 3 MONTHS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Time frame: 6 MONTHS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Time frame: BASELINE
UPPER LIP LINES SEVERITY ASSESSMENT
Time frame: 3 WEEKS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Time frame: 3 MONTHS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Time frame: 6 MONTHS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Time frame: BASELINE
CHEEK FOLDS SEVERITY ASSESSMENT
Time frame: 3 WEEKS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Time frame: 3 MONTHS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Time frame: 6 MONTHS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Time frame: baseline
LIP ENHANCEMENT ASSESSMENT
Time frame: 3 WEEKS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Time frame: 3 MONTHS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Time frame: 6 MONTHS AFTER LAST INJECTION

Results and safety

Results posted to the registry on 7 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hyaluronic Acid	77	76

Primary outcome: Full Face Global Aesthetic Improvement

Time frame: 3 weeks after last injection. Mean (Standard Deviation). Unit: units on a scale

Measure	Hyaluronic Acid n = 77
Value	2.5 (0.6)

Population analysed: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

Primary outcome: Full Face Global Aesthetic Improvement

Time frame: 3 months after last injection. Mean (Standard Error). Unit: units on a scale

Measure	Hyaluronic Acid n = 75
Value	2.4 (0.6)

Population analysed: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

Primary outcome: Full Face Global Aesthetic Improvement

Time frame: 6 months after last injection. Mean (Standard Deviation). Unit: units on a scale

Measure	Hyaluronic Acid n = 76
Value	1.8 (0.9)

Population analysed: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the study period (maximum of 24 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hyaluronic Acid	0 of 77 (0%)	5 of 77 (6.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Facial Wrinkles

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Evaluation of MD60002 Device for Facial Skin Aging
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Recruiting
Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality
Photoaged Facial Skin, Photoaging
Not yet recruiting
Antioxidant Nutrition and Facial Exercise for Skin Aging
Facial Skin Aging and Wrinkle Severity
Not yet recruitingObservational study
Comparing Facial Aging Between Identical Twins With 3D Imaging
Facial Skin Aging, Facial Volume Loss
Not yet recruiting
Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
Facial Wrinkles, Jawline Contour

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philippe KESTEMONT principal investigator

Investigational site Nice France

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing hyaluronic acid dermal fillers in people with Facial Wrinkles, run by Galderma R&D at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Full Face Global Aesthetic Improvement (time frame: 3 weeks after last injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01151436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.