AestheticsECLAHNCT02703740
Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds
A study testing Hyaluronic acid dermal filler with lidocaine 0.3% in people with Aesthetics, run by Laboratoires Genévrier at 1 site in France.
Trial summary
This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aesthetics
- What is being tested?
- Hyaluronic acid dermal filler with lidocaine 0.3%
- 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
- 1 siteFrance
- Study dates
- 11 Jan 2016to 3 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is at least 19 years of age.
- Has Fitzpatrick Skin Type IV, V, or VI.
- Has a WSRS score > or = to 3 for both NLF
- Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months
Who cannot join
- Has keloid formation, or hypertrophic scarring or dyschromic scaring. Has hypersensitivity to hyaluronic acid, Chlorhexidine lidocaine or local anaesthetic drugs
- Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
- Has nasolabial folds that are too severe to be corrected in one treatment session.
- Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold during the last year.
- Is pregnant, lactating, or not using acceptable contraception.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).
Read the detailed description
Interventional, monocentric, double blind, randomised study Evaluation of safety the 1st month (primary criteria) and until 12 month Evaluation of performance at baseline, month 3, month 6, month 9 and month 12 : WSRS (wrinkle scale), profilometry (image measuring wrinkle depth and area), GAIS : satisfaction scale
- Conditions
- Aesthetics
- Being tested
- Hyaluronic acid dermal filler with lidocaine 0.3%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid dermal filler with lidocaine 0.3%Device
injection in labial fold of a dermal filler
| Study group | Role | What they receive |
|---|---|---|
| HA 20 mg/mL | Experimental | Not described Receives: Device: Hyaluronic acid dermal filler with lidocaine 0.3% |
| HA 24 mg/mL | Experimental | Not described Receives: Device: Hyaluronic acid dermal filler with lidocaine 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and description of adverse events that are related to treatment
Measured: 1 month
Secondary outcomes (2)
Number and description of adverse events that are related to treatment
Measured: 72h/3 months/6 Months/9 months/12 months
Treatment efficacy assessed by WSRS
WSRS (wrinkle severity rating scale) : a 5-point validated scale ranging from 1 (absent) to 5 (extreme).
Measured: 1/3/6/9/12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start11 Jan 2016
- Primary completion3 Feb 2017
- Study completion3 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AestheticsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Genévrier
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703740
- Sponsor's protocol ID
- 15F/IALE01
- Acronym
- ECLAH
- Status last verified
- Oct 2019
- First submitted
- 18 Jan 2016
- Last updated
- 14 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT02703740
- Acronym / sponsor ID
- ECLAH / 15F/IALE01
- Conditions
- Aesthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Laboratoires GenévrierIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).
Detailed description
Interventional, monocentric, double blind, randomised study Evaluation of safety the 1st month (primary criteria) and until 12 month Evaluation of performance at baseline, month 3, month 6, month 9 and month 12 : WSRS (wrinkle scale), profilometry (image measuring wrinkle depth and area), GAIS : satisfaction scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA 20 mg/mL | Experimental | Device: Hyaluronic acid dermal filler with lidocaine 0.3% |
| HA 24 mg/mL | Experimental | Device: Hyaluronic acid dermal filler with lidocaine 0.3% |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is at least 19 years of age.
- Has Fitzpatrick Skin Type IV, V, or VI.
- Has a WSRS score > or = to 3 for both NLF
- Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months
Key exclusion criteria (5 listed)
- Has keloid formation, or hypertrophic scarring or dyschromic scaring. Has hypersensitivity to hyaluronic acid, Chlorhexidine lidocaine or local anaesthetic drugs
- Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
- Has nasolabial folds that are too severe to be corrected in one treatment session.
- Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold during the last year.
- Is pregnant, lactating, or not using acceptable contraception.
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 with lidocaine 0.3%injection in labial fold of a dermal filler | Device | HA 20 mg/mL, HA 24 mg/mL |
Primary outcome
Number and description of adverse events that are related to treatment
Time frame: 1 month
2 secondary outcomes
Number and description of adverse events that are related to treatment
Time frame: 72h/3 months/6 Months/9 months/12 months
Treatment efficacy assessed by WSRS
Time frame: 1/3/6/9/12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 with lidocaine 0.3% in people with Aesthetics, run by Laboratoires Genévrier at 1 site in France.
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 4 inclusion and 5 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 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number and description of adverse events that are related to treatment (time frame: 1 month). 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 14 Oct 2019.