Healthy VolunteersNCT02565784
Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population
A study testing Restylane and Perlane in people with Healthy Volunteers, run by Galderma R&D at 2 sites in Taiwan.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Restylane and Perlane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- Dec 2015to 28 Sep 2018
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects intent to undergo facial filler treatment for either volume loss or contouring
- Subjects requiring treatment in two to four of pre-defined areas in the face (upper cheeks, nasolabial folds, temples, nose and chin)
- Require 3-5 ml of investigational products to achieve a clinically meaningful improvement in appearance
- Facial appearance as Han Chinese
- Non-pregnant, non-breast feeding female
- Signed informed consent
Who cannot join
- Previous facial surgery (e.g. rhinoplasty) or permanent implant in the area to be treated.
- History of chronic sinusitis or rhinitis (only applicable for subjects injected in the nose).
- Subjects who needs to use heavy glasses during the study (only applicable for subjects injected in the nose).
- Previous tissue augmenting therapy or contouring with permanent filler or fat injection in the facial area.
- Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skinboosters in the facial area within 12 months before treatment.
- Previous treatment with non-HA fillers such as CaHA (Calcium Hydroxylapatite) or PLLA (Poly L-Lactic Acid) within 24 months before treatment.
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- Previous revitalization with neurotoxin in the facial area within six (6) months before treatment.
- Previous tissue revitalization treatment with laser or light, mesotherapy, chemical peeling or dermabrasion in the facial area within six (6) months before treatment.
- Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Galderma Research Site
Kaohsiung City
Galderma Research Site
Taipei
About this study
Official title: An Open, Evaluator-blinded, Non-comparative, Multi-center Study to Assess the Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population
The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.
- Conditions
- Healthy Volunteers
- Being tested
- Restylane, Perlane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestylaneDevice
Facial tissue augmentation
PerlaneDevice
Facial tissue augmentation
| Study group | Role | What they receive |
|---|---|---|
| Intradermal injection | Experimental | Restylane and/or Perlane Receives: Device: Restylane; Device: Perlane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant
Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment.
The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse.
A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.
Measured: 6 Months
Secondary outcomes (2)
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator
The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is "No folds" and 4 is "Very severe folds".
A participant is considered improved if she scores at least one grade improvement from baseline.
Measured: 6 and 12 Months after first and second treatment, respectively
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator
The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is "Full upper cheek" and 4 is "Very severely sunken upper cheek".
A participant is assessed as improved if she scores at least one grade improvement from baseline.
Measured: 6 and 12 Months after first and second treatment, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startDec 2015
- Primary completion29 Dec 2016
- Study completion28 Sep 2018
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 Healthy VolunteersStudies 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
- 100 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
- NCT02565784
- Sponsor's protocol ID
- 05DF1315
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2015
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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
- An Open, Evaluator-blinded, Non-comparative, Multi-center Study to Assess the Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population
- ClinicalTrials.gov ID
- NCT02565784
- Acronym / sponsor ID
- 05DF1315
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Posted 3 Oct 2019
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 this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intradermal injection | Experimental | Device: Restylane, Device: PerlaneRestylane and/or Perlane |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects intent to undergo facial filler treatment for either volume loss or contouring
- Subjects requiring treatment in two to four of pre-defined areas in the face (upper cheeks, nasolabial folds, temples, nose and chin)
- Require 3-5 ml of investigational products to achieve a clinically meaningful improvement in appearance
- Facial appearance as Han Chinese
- Non-pregnant, non-breast feeding female
Key exclusion criteria (9 listed)
- Previous facial surgery (e.g. rhinoplasty) or permanent implant in the area to be treated.
- History of chronic sinusitis or rhinitis (only applicable for subjects injected in the nose).
- Subjects who needs to use heavy glasses during the study (only applicable for subjects injected in the nose).
- Previous tissue augmenting therapy or contouring with permanent filler or fat injection in the facial area.
- Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skinboosters in the facial area within 12 months before treatment.
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 |
|---|---|---|
| RestylaneFacial tissue augmentation | Device | Intradermal injection |
| PerlaneFacial tissue augmentation | Device | Intradermal injection |
Primary outcome
Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant
Time frame: 6 Months
Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.
2 secondary outcomes
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator
Time frame: 6 and 12 Months after first and second treatment, respectively
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator
Time frame: 6 and 12 Months after first and second treatment, respectively
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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Screening Protocol
Pain
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane and Perlane in people with Healthy Volunteers, run by Galderma R&D at 2 sites in Taiwan.
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 6 inclusion and 9 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 2 sites in Taiwan. 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 3 Oct 2019). 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 Improved in "Global Facial Aesthetic Appearance" - Judged by Participant (time frame: 6 Months). 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.