Volume Loss (Soft Tissue Ptosis or Atrophy )EVENCT01545557
Pan Facial Volume Restoration
A study testing Hyaluronic acid dermal filler gel in people with Volume Loss (Soft Tissue Ptosis or Atrophy ), run by Galderma R&D at 3 sites in Brazil.
Trial summary
The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Volume Loss (Soft Tissue Ptosis or Atrophy )
- What is being tested?
- Hyaluronic acid dermal filler gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesBrazil
- Study dates
- 21 Feb 2012to 3 Mar 2014
- 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
- Subjects seeking treatment for correction of volume loss.
- Subjects presenting a score of at least 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on Lemperle rating scale) if cheekbones are injected.
Who cannot join
- Subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device,
- Subjects who underwent previous injection of permanent filler in the injected area.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Galderma Investigational Center
Botucatu
Galderma Investigational Center
Rio de Janeiro
Galderma Investigational Center
Saö Paulo
About this study
Official title: Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler
The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.
Read the detailed description
Clinical hypothesis: The global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators.
This device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly).
Study duration will be up to 19 months. Injections will be performed at baseline. If necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).
- Being tested
- Hyaluronic acid dermal filler gel
- Keywords
- Volume loss
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid dermal filler gelDevice
Also called Study filler is Emervel Volume Lidocaine.
1 Emervel Volume injection per indication and 1 touch-up injection if necessary
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid dermal filler | Experimental | One Emervel Volume injection at baseline and touch up injections 3 weeks after if needed Receives: Device: Hyaluronic acid dermal filler gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Volume Loss Assessment
Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.
Measured: Baseline and 18 Months after last injection
Secondary outcomes (4)
Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection
Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question ; Rate overall, full face aesthetic outcome using the following options: not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full face aesthetic outcome at 3 weeks after last injection were reported.
Measured: At 3 Weeks after last injection
Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler
The study investigators (injectors) were requested to complete a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler (Emervel® Volume Lidocaine). The percentage of investigators who agreed to use Emervel® Volume Lidocaine again were reported in this outcome measure.
Measured: Baseline up to 18 Months after last injection
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Baseline up to 18 Months after last injection
Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection
Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question; rate overall, full face aesthetic outcome using the following options : not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full-face aesthetic outcome at 18 Months after last injection were reported.
Measured: At 18 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.
- First posted6 Mar 2012 (estimated)
- Study start21 Feb 2012
- Primary completion3 Mar 2014
- Study completion3 Mar 2014
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 Volume Loss (Soft Tissue Ptosis or Atrophy )Studies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Scientist, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545557
- Sponsor's protocol ID
- RD.03.CIP.29090
- Acronym
- EVE
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2012
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler
- ClinicalTrials.gov ID
- NCT01545557
- Acronym / sponsor ID
- EVE / RD.03.CIP.29090
- Keywords
- Volume loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2012 (actual)
- Primary completion
- 3 Mar 2014 (actual)
- Study completion
- 3 Mar 2014 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.
Detailed description
Clinical hypothesis: The global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators.
This device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly).
Study duration will be up to 19 months. Injections will be performed at baseline. If necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).
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 dermal filler | Experimental | Device: Hyaluronic acid dermal filler gelOne Emervel Volume injection at baseline and touch up injections 3 weeks after if needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects seeking treatment for correction of volume loss.
- Subjects presenting a score of at least 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on Lemperle rating scale) if cheekbones are injected.
Key exclusion criteria (2 listed)
- Subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device,
- Subjects 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 filler gelAlso: Study filler is Emervel Volume Lidocaine.1 Emervel Volume injection per indication and 1 touch-up injection if necessary | Device | Hyaluronic acid dermal filler |
Primary outcome
Mean Change From Baseline in Volume Loss Assessment
Time frame: Baseline and 18 Months after last injection
Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.
4 secondary outcomes
Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection
Time frame: At 3 Weeks after last injection
Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler
Time frame: Baseline up to 18 Months after last injection
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to 18 Months after last injection
Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection
Time frame: At 18 Months after last injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Volume Loss (Soft Tissue Ptosis or Atrophy )
RecruitingPhase 4
Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
Volume Loss (Soft Tissue Ptosis or Atrophy )
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.
Clinical Scientist study director
Galderma R&D
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid dermal filler gel in people with Volume Loss (Soft Tissue Ptosis or Atrophy ), run by Galderma R&D at 3 sites in Brazil.
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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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 1 Mar 2023). 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?
Mean Change From Baseline in Volume Loss Assessment (time frame: Baseline and 18 Months after last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2023.