Volume Deficiency of the Midface05DF1707NCT03869450
A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers
A study testing Restylane Volyme, Restylane Defyne and Restylane Lyft Lidocaine in people with Volume Deficiency of the Midface, run by Galderma R&D at 3 sites in 3 countries.
Trial summary
The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring). Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Volume Deficiency of the Midface
- What is being tested?
- Restylane Volyme, Restylane Defyne and Restylane Lyft Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 Nov 2018to 30 Aug 2019
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface
- Signed and dated informed consent
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain
- Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area
- Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery
- Any medical condition that in the opinion of the Investigator would make the participant unsuitable for inclusion
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Multi-center, Evaluator-blinded Study to Evaluate Effectiveness and Safety of HA Fillers for Lifting, Contouring and Correcting Volume Deficiency of the Midface Using an Individualized Treatment Algorithm
The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).
- Conditions
- Volume Deficiency of the Midface
- Being tested
- Restylane Volyme, Restylane Defyne, Restylane Lyft Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane VolymeDevice
Hyaluronic based filler
Restylane DefyneDevice
Hyaluronic based filler
Restylane Lyft LidocaineDevice
Hyaluronic based filler
| Study group | Role | What they receive |
|---|---|---|
| Restylane Volyme | Experimental | According to the treatment algorithm, treated with Restylane Volyme Receives: Device: Restylane Volyme |
| Restylane Defyne | Experimental | According to the treatment algorithm, treated with Restylane Defyne Receives: Device: Restylane Defyne |
| Restylane Lyft Lidocaine | Experimental | According to the treatment algorithm, treated with Restylane Lyft Lidocaine Receives: Device: Restylane Lyft Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Aesthetic Improvement of Midface
A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.
Measured: 8 weeks
Secondary outcomes (2)
Percentage of Participants With Improved Midface Volume
A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness.
Improved midface volume was defined as at least a 1-grade decrease from baseline.
Measured: 8 weeks
Percentage of Participants Assessed as Having Natural Treatment Results
Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question "Are the subject's treatment results natural looking?". Having natural treatment results is defined as being assessed with answers Strongly agree or Agree.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start9 Nov 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
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 Deficiency of the MidfaceStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Q-Med AB, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869450
- Sponsor's protocol ID
- 05DF1707
- Acronym
- 05DF1707
- Status last verified
- Apr 2020
- First submitted
- 14 Nov 2018
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Evaluator-blinded Study to Evaluate Effectiveness and Safety of HA Fillers for Lifting, Contouring and Correcting Volume Deficiency of the Midface Using an Individualized Treatment Algorithm
- ClinicalTrials.gov ID
- NCT03869450
- Acronym / sponsor ID
- 05DF1707 / 05DF1707
- Conditions
- Volume Deficiency of the Midface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 2 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Restylane Volyme | Experimental | Device: Restylane VolymeAccording to the treatment algorithm, treated with Restylane Volyme |
| Restylane Defyne | Experimental | Device: Restylane DefyneAccording to the treatment algorithm, treated with Restylane Defyne |
| Restylane Lyft Lidocaine | Experimental | Device: Restylane Lyft LidocaineAccording to the treatment algorithm, treated with Restylane Lyft Lidocaine |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface
- Signed and dated informed consent
Key exclusion criteria (4 listed)
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain
- Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area
- Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery
- Any medical condition that in the opinion of the Investigator would make the participant unsuitable for inclusion
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 |
|---|---|---|
| Restylane VolymeHyaluronic based filler | Device | Restylane Volyme |
| Restylane DefyneHyaluronic based filler | Device | Restylane Defyne |
| Restylane Lyft LidocaineHyaluronic based filler | Device | Restylane Lyft Lidocaine |
Primary outcome
Percentage of Participants With Aesthetic Improvement of Midface
Time frame: 8 weeks
A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.
2 secondary outcomes
Percentage of Participants With Improved Midface Volume
Time frame: 8 weeks
Percentage of Participants Assessed as Having Natural Treatment Results
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Q-Med AB study director
Galderma R&D
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Volyme, Restylane Defyne and Restylane Lyft Lidocaine in people with Volume Deficiency of the Midface, run by Galderma R&D at 3 sites in 3 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 4 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 26 Aug 2022. 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 Germany, Italy, United Kingdom. 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 2 Apr 2020). 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?
Percentage of Participants With Aesthetic Improvement of Midface (time frame: 8 weeks). 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 26 Aug 2022.