AgingMLIDOMNCT05087732
Effectiveness and Safety of STYLAGE® M LIDOCAINE Versus STYLAGE® M in Filling Nasolabial Folds
A study testing STYLAGE® M Lidocaïne and STYLAGE® M in people with Aging, run by Laboratoires Vivacy at 1 site in France.
Trial summary
This clinical investigation is designed to compare the STYLAGE® M Lidocaïne to STYLAGE® M in terms of correction of nasolabial folds severity and pain felt by the subject, and to assess and compare the safety and effectiveness of both products. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- STYLAGE® M Lidocaïne and STYLAGE® M
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2021to 24 Nov 2022
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject.
- Age: between 30 and 65 years.
- Subject with right and left NLF rating grade 3 or 4 (Moderate or Severe) on the Wrinkle Severity Rating Scale (WSRS), as assessed by a Blinded Live Evaluator.
- Subject having the same WSRS grade on both NLFs (i.e., symmetrical NLFs).
- Subject with marionette's lines that do not require to be treated in addition to nasolabial folds, according to the Blinded Live Evaluator.
- Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures (i.e., dermal fillers, toxin treatments, facial ablative or fractional laser, microdermal abrasion, chemical peels, non-invasive skin-tightening) below the level of the lower orbital rim, for the duration of the study.
Show all 13Show fewer
- Subjects agreeing not to take Anti-histamines within 2 weeks prior to touch-up visit
- Subject able to comply with protocol requirements and to complete all required visits.
- Subject, psychologically able to understand the study related information and to give a written informed consent.
- Subject having given freely and expressly his/her informed consent to participate in the study, and use of data privacy, prior to any study-related procedure being performed.
- Subject agreeing to have photographs taken.
- Female of childbearing potential must have a negative urinary pregnancy test (UPT) at Visit 1 and practice a reliable method of contraception throughout the study, and for at least 12 weeks prior to study enrolment.
- Subject affiliated to a health social security.
Who cannot join
- Subject presenting any symptom which can be related to a medical condition that is likely to make the subject not being compliant with the study schedule, at the discretion of the investigator
- Pregnant or breastfeeding woman or planning a pregnancy during the study.
- Had prior surgery in the mid- and/or lower-face area, including the nasolabial fold(s), or has a permanent implant or graft in the mid- and/or lower-face area, or a tattoo, a scar, moles, or anything that could interfere with effectiveness assessments. (NOTE: Rhinoplasty is permitted if the procedure was ≥ 12 months prior to study enrolment).
- Subject in a social or sanitary establishment.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject participating to another research on human beings or who is in an exclusion period of one.
Show all 27Show fewer
- Subject having received 4500 euros indemnities for participation in researches involving human beings in France in the 12 previous months, including participation in the present study.
- Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats with cardiac localisation.
- Subjects suffering from porphyria.
- Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…). Subject with recurrent herpes is not eligible even if asymptomatic at time of inclusion.
- Subject having history of severe allergy or anaphylactic shock including hypersensitivity to hyaluronic acid, to gram positive bacterial proteins, to lidocaine or antiseptic solution or amide type local anaesthetics.
- Subject predisposed to develop keloids or hypertrophic scarring.
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- Subject having received treatment with a laser, a dermabrasion, a surgery, a peeling or other ablative procedure below the inferior orbital rim within the past 6 months prior to study start.
- Subject having received injection with a resorbable filling product (eg, hyaluronic acid, collagen) below the inferior orbital rim within the past 12 months prior to study start.
- Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), etc.) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, etc.).
- Subject having received at any time a treatment with tensor threads below the inferior orbital rim.
- Subject who received oral surgery (tooth extraction, orthodontia or implantation) within 6 weeks prior to study start or who plans to undergo any of these procedures during the study.
- Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to study start or planning to change it during the study.
- Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofen, naproxen, etc.), antiplatelet agents, anticoagulants, vitamin C or other substances known to increase coagulation time within one week prior to treatment dates.
- Subject using medication that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc.).
- Subject undergoing a topical treatment on the test area or a systemic treatment:
- Anti-histamines during the 2 weeks prior to study start;
- Immunosuppressors and/or corticoids during the 4 weeks prior to study start;
- Retinoids during the 6 months prior to study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Triple Blinded, Randomized, Controlled Clinical Study of the Effectiveness and Safety of STYLAGE® M LIDOCAINE Versus STYLAGE® M in Filling Nasolabial Folds
This clinical investigation is designed to compare the STYLAGE® M Lidocaïne to STYLAGE® M in terms of correction of nasolabial folds severity and pain felt by the subject, and to assess and compare the safety and effectiveness of both products.
Subjects with moderate to severe nasolabial folds will receive both treatments in a split-face design at D0, and a touch-up will be done 14 days after if necessary. The subjects will be followed-up over a 12-month period after initial injection.
Read the detailed description
The study will be prospective, triple-blinded (Subject, Treating Investigator, and Blinded Live Evaluator),randomized,within-subjects (split-face),active-controlled, monocenter with blinded subjects and evaluators assessing the efficacy , safety and pain of STYLAGE® M Lidocaïne and STYLAGE® M in the treatment of nasolabial folds.
Sixty five healthy subjects between the age of 30 and 65, with symetrical moderate to severe nasolabial folds with grade 3 or 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled.
STYLAGE® M Lidocaïne will be injected in one nasolabial fold (right or left according to the randomization list). STYLAGE® M will be injected in the contralateral nasolabial fold.
A touch-up is possible if required 14 days after. Subjects will be followed up at 14 days, 3, 6 and 12 months timepoints. All the effectiveness and safety evaluations will be done by a Blinded Live Evaluator (BLE) who will be different from the Treating Investigators.
Variation in severity score of nasolabial folds will be assessed in live by the BLE and retrospectively assessed on photographs (2D) by an Independent Photographic Reviewer using the validated 5-point Wrinkles Severity Rating Scale (WSRS) at each time point The subjects and the independent blinded evaluator will assess the overall aesthetic improvement level of the face, for each side independently, at each time point after treatment initiation The subjects will be asked to score the pain felt during injection, and 5, 15 and 30 minutes after injection on a Visual Analog Scale .
- Conditions
- Aging
- Being tested
- STYLAGE® M Lidocaïne, STYLAGE® M
- Keywords
- hyaluronic acid, Nasolabial Folds, Injection, Healthy subjects, Prospective, Randomized, Pain, Within-subjects
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STYLAGE® M LidocaïneDevice
Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).
STYLAGE® MDevice
Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).
| Study group | Role | What they receive |
|---|---|---|
| Stylage® M Lidocaïne | Experimental | STYLAGE® M Lidocaine is a hyalorunic acid injectable gel with Lidocaine hydrochloride whose intended purpose is the filling of skin depressions on the face by dermal injection. Receives: Device: STYLAGE® M Lidocaïne; Device: STYLAGE® M |
| Stylage® M | Active comparator | STYLAGE® M Lidocaine is a hyalorunic acid injectable gel whose intended purpose is the filling of skin depressions on the face by dermal injection. Receives: Device: STYLAGE® M Lidocaïne; Device: STYLAGE® M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of aesthetic improvement on the Wrinkle Severity Rating Scale (WSRS),
First co-primary endpoint will be the difference of aesthetic improvement on the Wrinkle Severity Rating Scale (WSRS), as evaluated by the BLE, at the side of the face treated with Stylage® M lidocaïne compared to the side of the face treated with Stylage® M, in a double non-inferiority statistical model.
Measured: 6 months
Within-subject difference in injection site pain
Second co-primary endpoint will be the (STYLAGE® M Side - STYLAGE® M lidocaine Side), self-assessed by the subjects on a 100 mm Visual Analogue Scale (VAS), in a superiority statistical model.
Measured: immediatly after injection of each side
Secondary outcomes (14)
WSRS change from baseline
WSRS change from baseline as assessed by the Blinded Live Evaluator (BLE)
Measured: 4 days, 3, and 12 months after baseline
WSRS change from baseline on photographs
WSRS change from baseline as assessed by an Independent Photographic Reviewer (IPR), on photographs.
Measured: 14 days, 3, 6, and 12 months after baseline
Responder rate for WSRS in live
Responder rate for WSRS , as assessed by the BLE. A responder is defined as a subject with at least 1-point improvement from baseline on the WSRS.
Measured: 14 days, 3, 6, and 12 months after baseline
Responder rate for WSRS on photograph
Responder rate for WSRS , as assessed by an Independent Photographic Reviewer (IPR), on photographs.
Measured: 14 days, 3, 6 and 12 months after baseline
Global Aesthetic Improvement assessed by the BLE
Global Aesthetic Improvement assessed by the BLE on the Global Aesthetic Improvement Scale (GAIS).
Measured: 14 days, 3, 6, and 12 months after baseline
Global Aesthetic Improvement assessed by the Subject
Global Aesthetic Improvement assessed by the Subject on the Global Aesthetic Improvement Scale (GAIS).
Measured: 14 days, 3, 6, and 12 months after baseline
Proportions of GAIS responders assessed by the BLE
Proportions of GAIS responders defined as subjects with a GAIS score " Improved ", " Much Improved ", or " Very Much Improved ", as assessed by the BLE
Measured: 14 days, 3, 6, and 12 months after baseline.
Proportions of GAIS responders assessed by the subjects
Proportions of GAIS responders defined as subjects with a Global Aesthetic " Improved ", " Much Improved ", or " Very Much Improved ", as assessed by the subjects
Measured: 14 days, 3, 6, and 12 months after baseline.
Subject Satisfaction questionnaire
Proportion of subjects either " Somehow satisfied ", " Satisfied ", or " Very Satisfied ", as assessed by the subjects
Measured: 14 days, 3, 6, and 12 months
Injection Site Pain self-assessed by the subjects (touch-up)
Injection Site Pain during injection self-assessed by the subjects of each side during optional touch-up treatment (VAS 100mm).
Measured: immediatly after touch-up injection
Injection Site Pain self-assessed by the subjects (initial and touch-up)
Injection Site Pain self-assessed by the subjects at during initial and optional touch-up treatment.
Measured: 5, 15, and 30 minutes post-injection
Proportion of subjects who reported at least 10 mm, 20 mm, and 30 mm less VAS pain (initial and touch-up).
Proportion of subjects who reported at least 10 mm, 20 mm, and 30 mm less VAS pain associated with injections of Stylage® M Lidocaïne compared to Stylage® M, immediately after injection (initial and touch-up).
Measured: immediately after injection, and at 5, 15, and 30 minutes after each injection
Proportion of subjects that reported at least half less VAS pain (initial and touch-up)
Proportion of subjects that reported at least half less VAS pain associated with injections of Stylage® M Lidocaïne compared to Stylage® M (initial and touch-up).
Measured: Immediately after injection, and at 5, 15, and 30 minutes after each injection
Injection site reaction and adverse events reporting
Product tolerance will be assessed by collection of Injection Site Reactions (ISRs) after each injection session, and Adverse Events throughout the study.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start19 Oct 2021
- Primary completion18 May 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Single group
- Model description
- Within-subject study with treatment of one nasolabial fold with STYLAGE® M and STYLAGE® M Lidocaïne of the other nasolabial fold
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siham RHARBAOUI, Principal investigator, Dermscan Pharmascan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087732
- Sponsor's protocol ID
- VIV-STYL-LIDO-01
- Acronym
- MLIDOM
- Status last verified
- Dec 2022
- First submitted
- 12 Oct 2021
- Last updated
- 2 Dec 2022
- Results posted
- No
- 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 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Triple Blinded, Randomized, Controlled Clinical Study of the Effectiveness and Safety of STYLAGE® M LIDOCAINE Versus STYLAGE® M in Filling Nasolabial Folds
- ClinicalTrials.gov ID
- NCT05087732
- Acronym / sponsor ID
- MLIDOM / VIV-STYL-LIDO-01
- Conditions
- Aging
- Keywords
- hyaluronic acid, Nasolabial Folds, Injection, Healthy subjects, Prospective, Randomized, Pain, Within-subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 21 Oct 2021 (actual)
- 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 clinical investigation is designed to compare the STYLAGE® M Lidocaïne to STYLAGE® M in terms of correction of nasolabial folds severity and pain felt by the subject, and to assess and compare the safety and effectiveness of both products.
Subjects with moderate to severe nasolabial folds will receive both treatments in a split-face design at D0, and a touch-up will be done 14 days after if necessary. The subjects will be followed-up over a 12-month period after initial injection.
Detailed description
The study will be prospective, triple-blinded (Subject, Treating Investigator, and Blinded Live Evaluator),randomized,within-subjects (split-face),active-controlled, monocenter with blinded subjects and evaluators assessing the efficacy , safety and pain of STYLAGE® M Lidocaïne and STYLAGE® M in the treatment of nasolabial folds.
Sixty five healthy subjects between the age of 30 and 65, with symetrical moderate to severe nasolabial folds with grade 3 or 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled.
STYLAGE® M Lidocaïne will be injected in one nasolabial fold (right or left according to the randomization list). STYLAGE® M will be injected in the contralateral nasolabial fold.
A touch-up is possible if required 14 days after. Subjects will be followed up at 14 days, 3, 6 and 12 months timepoints. All the effectiveness and safety evaluations will be done by a Blinded Live Evaluator (BLE) who will be different from the Treating Investigators.
Variation in severity score of nasolabial folds will be assessed in live by the BLE and retrospectively assessed on photographs (2D) by an Independent Photographic Reviewer using the validated 5-point Wrinkles Severity Rating Scale (WSRS) at each time point The subjects and the independent blinded evaluator will assess the overall aesthetic improvement level of the face, for each side independently, at each time point after treatment initiation The subjects will be asked to score the pain felt during injection, and 5, 15 and 30 minutes after injection on a Visual Analog Scale .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subject study with treatment of one nasolabial fold with STYLAGE® M and STYLAGE® M Lidocaïne of the other nasolabial fold
| Arm | Type | Receives |
|---|---|---|
| Stylage® M Lidocaïne | Experimental | Device: STYLAGE® M Lidocaïne, Device: STYLAGE® MSTYLAGE® M Lidocaine is a hyalorunic acid injectable gel with Lidocaine hydrochloride whose intended purpose is the filling of skin depressions on the face by dermal injection. |
| Stylage® M | Active comparator | Device: STYLAGE® M Lidocaïne, Device: STYLAGE® MSTYLAGE® M Lidocaine is a hyalorunic acid injectable gel whose intended purpose is the filling of skin depressions on the face by dermal injection. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy subject.
- Age: between 30 and 65 years.
- Subject with right and left NLF rating grade 3 or 4 (Moderate or Severe) on the Wrinkle Severity Rating Scale (WSRS), as assessed by a Blinded Live Evaluator.
- Subject having the same WSRS grade on both NLFs (i.e., symmetrical NLFs).
- Subject with marionette's lines that do not require to be treated in addition to nasolabial folds, according to the Blinded Live Evaluator.
Key exclusion criteria (27 listed)
- Subject presenting any symptom which can be related to a medical condition that is likely to make the subject not being compliant with the study schedule, at the discretion of the investigator
- Pregnant or breastfeeding woman or planning a pregnancy during the study.
- Had prior surgery in the mid- and/or lower-face area, including the nasolabial fold(s), or has a permanent implant or graft in the mid- and/or lower-face area, or a tattoo, a scar, moles, or anything that could interfere with effectiveness assessments. (NOTE: Rhinoplasty is permitted if the procedure was ≥ 12 months prior to study enrolment).
- Subject in a social or sanitary establishment.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
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 |
|---|---|---|
| STYLAGE® M LidocaïneUp to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up). | Device | Stylage® M, Stylage® M Lidocaïne |
| STYLAGE® MUp to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up). | Device | Stylage® M, Stylage® M Lidocaïne |
Primary outcome
Difference of aesthetic improvement on the Wrinkle Severity Rating Scale (WSRS),
Time frame: 6 months
First co-primary endpoint will be the difference of aesthetic improvement on the Wrinkle Severity Rating Scale (WSRS), as evaluated by the BLE, at the side of the face treated with Stylage® M lidocaïne compared to the side of the face treated with Stylage® M, in a double non-inferiority statistical model.
Within-subject difference in injection site pain
Time frame: immediatly after injection of each side
Second co-primary endpoint will be the (STYLAGE® M Side - STYLAGE® M lidocaine Side), self-assessed by the subjects on a 100 mm Visual Analogue Scale (VAS), in a superiority statistical model.
14 secondary outcomes
WSRS change from baseline
Time frame: 4 days, 3, and 12 months after baseline
WSRS change from baseline on photographs
Time frame: 14 days, 3, 6, and 12 months after baseline
Responder rate for WSRS in live
Time frame: 14 days, 3, 6, and 12 months after baseline
Responder rate for WSRS on photograph
Time frame: 14 days, 3, 6 and 12 months after baseline
Global Aesthetic Improvement assessed by the BLE
Time frame: 14 days, 3, 6, and 12 months after baseline
Global Aesthetic Improvement assessed by the Subject
Time frame: 14 days, 3, 6, and 12 months after baseline
Proportions of GAIS responders assessed by the BLE
Time frame: 14 days, 3, 6, and 12 months after baseline.
Proportions of GAIS responders assessed by the subjects
Time frame: 14 days, 3, 6, and 12 months after baseline.
Subject Satisfaction questionnaire
Time frame: 14 days, 3, 6, and 12 months
Injection Site Pain self-assessed by the subjects (touch-up)
Time frame: immediatly after touch-up injection
Injection Site Pain self-assessed by the subjects (initial and touch-up)
Time frame: 5, 15, and 30 minutes post-injection
Proportion of subjects who reported at least 10 mm, 20 mm, and 30 mm less VAS pain (initial and touch-up).
Time frame: immediately after injection, and at 5, 15, and 30 minutes after each injection
Proportion of subjects that reported at least half less VAS pain (initial and touch-up)
Time frame: Immediately after injection, and at 5, 15, and 30 minutes after each injection
Injection site reaction and adverse events reporting
Time frame: up to 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 2 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
Siham RHARBAOUI principal investigator
Dermscan Pharmascan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STYLAGE® M Lidocaïne and STYLAGE® M in people with Aging, run by Laboratoires Vivacy 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 13 inclusion and 27 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 2 Dec 2022. 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?
Difference of aesthetic improvement on the Wrinkle Severity Rating Scale (WSRS), (time frame: 6 months). The study lists 2 primary outcomes in all. 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 2 Dec 2022.