AgingFLASHNCT05809739
Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck
A study testing STYLAGE Hydro in people with Aging, run by Laboratoires Vivacy at 2 sites in France.
Trial summary
FLASH Study is a Post-Market Follow-Up PCMF designed to evaluate the tolerance and efficacy of STYLAGE Hydro by using a satisfaction questionnaire. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- STYLAGE Hydro
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Feb 2023to 1 Feb 2024
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject.
- Sex: female.
- Age: between 30 and 70 years.
- Subject having given freely and expressly her informed consent and data privacy consent.
- Subject with signs of cutaneous dryness and lack of elasticity on the face, on the neckline area and if applicable on the neck (if neck is planned to be treated) following investigator assessment.
- Subject willing to have photographs of the face, neck and neckline taken.
Show all 12Show fewer
- Subject psychologically able to understand the study related information and to give a written informed consent.
- Subject affiliated to a health social security system.
- Subject agreeing not to receive another aesthetic procedure (e.g., laser, dermabrasion, surgery, deep chemical peeling, surface peel, tensor threads, injection with a filling product) on the face, the neckline area and if applicable on the neck (if neck is planned to be treated) during the whole study.
- Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before screening visit and during the whole study.
- Subject agreeing to keep their usual cleansing / care products during the whole study period.
- Subject agreeing to apply a SPF50 cream during non-intensive exposure to sunlight.
Who cannot join
- Pregnant or breastfeeding woman or planning a pregnancy during the study.
- Subject with a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject participating to another research on human beings or who is in an exclusion period of one.
- Subject having received 6000 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study. (France only)
Show all 28Show fewer
- Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- Subject suffering from autoimmune disease and/or immune deficiency.
- Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…). Subject with recurrent herpes is eligible if asymptomatic at time of inclusion.
- Subject having history of hypersensitivity to hyaluronic acid or to one of the components of the tested device, anaesthetic product or antiseptic solution.
- Subject having history of anaphylactic shock or severe and/or evolutive / unstable / recent allergy.
- Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats.
- Subject predisposed to develop keloids or hypertrophic scars.
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- Subject having received treatment with a laser on the face, the neckline area or if applicable the neck within the past 6 months prior to screening visit.
- Subject having received a superficial, medium, or deep peeling on the face, the neckline area or if applicable the neck within the past month, 3 or 12 months respectively prior to screening visit.
- Subject having received injection with a reticulated hyaluronic acid (HA), on the face, the neckline area or if applicable the neck within the past 12 months prior to screening visit.
- Subject having received injection with a non-reticulated hyaluronic acid (HA) or botulinum toxin on the face, the neckline area or if applicable the neck within the past 6 months prior to screening visit.
- Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of HA and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …),a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …) or tensor threads on the face, the neckline area or if applicable the neck.
- Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit.
- Subject using medication such as aspirin, NSAIDs (ibuprofen, ketoprofen, naproxen…), platelet aggregation inhibitors, anticoagulants, vitamin C within one week prior to injection visit (V1) and agreeing not to take such treatments within 1 week prior to the second (V2) and third injections (V3).
- Subject having history of immunosuppressors taking.
- Subject undergoing a topical treatment on the test area or a systemic treatment:
- Anti-histamines during the 3 days prior to injection visit (V1) and agreeing not to take such treatment during the study as far as possible;
- Corticoids during the 4 weeks prior to screening visit;
- Retinoids during the 6 months prior to screening visit.
- Subject having changed her topical cleansing / care products within the month prior to screening visit.
- Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Eurofins Dermscan
Aix-en-Provence, 13290
Eurofins Dermscan Pharmascan
Villeurbanne, 69100
About this study
Official title: FLASH Study: Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck
FLASH Study is a Post-Market Follow-Up PCMF designed to evaluate the tolerance and efficacy of STYLAGE Hydro by using a satisfaction questionnaire.
Read the detailed description
This is a prospective, in open, single arm and multicentric study designed to evaluate the tolerance and efficacy of STYLAGE Hydro.
Patients will be injected up to 2 mL of STYLAGE Hydro per area at each session. Three injection sessions 2 weeks apart are planned: one at visit 1 (D0), one at visit 2 (W2) and one at visit 3 (W4).
Proportions of subjects who are satisfied on the face 6 weeks after treatment initiation will be assessed. For each question of the questionnaire, the subjects who are satisfied are defined as subjects who rated "Somewhat agree", "Agree" or "Totally agree". Global aesthetic improvement according to independent evaluator and subjects' satisfaction will also be done during other visits. Safety parameters will be evaluated during the study period.
- Conditions
- Aging
- Being tested
- STYLAGE Hydro
- Keywords
- hyaluronic acid, Injection, Healthy subjects, Prospective, Single arm, ISR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STYLAGE HydroDevice
3 sessions of injections (J0, J14 and J28)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Device: STYLAGE® Hydro
1 mL up to 2.0 mL per area will be injected in the face, neckline and neck (optionally) at each injection session. Receives: Device: STYLAGE Hydro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's satisfaction with STYLAGE® HYDRO on the face
Proportions of subjects who are satisfied after treatment using a questionnaire (question 1 to 7)
Measured: 6 weeks after treatment initiation
Secondary outcomes (15)
Subject's satisfaction with STYLAGE® HYDRO on the face
Proportions of subjects who are satisfied after treatment using a questionnaire (since question 8 on week 7) and mean changes from baseline in subject's scores for satisfaction using the FACE-Q satisfaction with skin questionnaire.
For FACE-Q questionnaire, the minimum score of 1 means a worse outcome and the maximum score of 4 means a better outcome.
Measured: 6, 9 and 12 weeks after treatment initiation
Subject's satisfaction with STYLAGE® HYDRO on the neckline area and if applicable on the neck
Proportions of subjects who are satisfied on the neckline area and if applicable on the neck after treatment using a questionnaire
Measured: 6, 9 and 12 weeks after treatment initiation
Investigator's satisfaction on the face, the neckline area and if applicable on the neck
Proportions of subjects for whom the investigator is satisfied on the face, the neckline area and if applicable on the neck after treatment using a questionnaire
Measured: 6 and12 weeks after treatment initiation
Effectiveness of STYLAGE® HYDRO in improving the subject's aesthetic appearance on the face, the neckline area and if applicable the neck
Proportions of GAIS responders on the face, the neckline area and if applicable on the neck as assessed by subject and investigator
Measured: 6, 9 and 12 weeks after treatment initiation for subject and at 7 and 12 weeks after treatment initiation for investigator
Effectiveness of STYLAGE® HYDRO on skin thickness on the face and neckline area
Mean change from baseline in average thickness of the epidermis and dermis (mm) on the face and neckline area after treatment using DermaScan C USB®
Measured: 6 and 12 weeks after treatment initiation
Effectiveness of STYLAGE® HYDRO on skin density on the face and neckline area
Mean changes from baseline in proportion of non-echogenic tissues (%) on the face and neckline area after treatment using DermaScan C USB®
Measured: 6 and 12 weeks after treatment initiation
Mean change in average roughness on the face
Mean change from baseline in average roughness (micrometer) on the face after treatment using Dermatop®
Measured: 6 and 12 weeks after treatment initiation
Mean change in average height of the roughness on the face
Mean change from baseline in average height of the roughness (micrometer) on the face after treatment using Dermatop®
Measured: 6 and 12 weeks after treatment initiation
Mean change in maximum height of the roughness profile on the face
Mean change from baseline in maximum height of the roughness profile (micrometer) on the face after treatment using Dermatop®
Measured: 6 and 12 weeks after treatment initiation
Mean change in arithmetic mean height of the roughness on the face and neckline area
Mean change from baseline in arithmetic mean height (micrometer) on the face and neckline area after treatment using C-Cube®
Measured: 6 and 12 weeks after treatment initiation
Mean change in root mean square height of roughness on the face and neckline area
Mean change from baseline in root mean square height (dimensionless) on the face and neckline area after treatment using C-Cube®
Measured: 6 and 12 weeks after treatment initiation
Mean change in ratio of the developed interfacial area on the face and neckline area
Mean changes from baseline in ratio of the developed interfacial area (%) on the face and neckline area after treatment using C-Cube®
Measured: 6 and 12 weeks after treatment initiation
Mean change in the depth of crow's feet wrinkles
Mean changes from baseline in the severity of crow's feet wrinkles after treatment using Dermatop®
Measured: 6 and 12 weeks after treatment initiation
Injection pain with STYLAGE® HYDRO
Mean pain scores during injection assessed by subject on a 100 mm Visual Analogue Scale (VAS).
Minimum value is 0 mm and maximum value is 100 mm. Higher scores mean a worse outcome.
Measured: Day 0, Day 14 and Day 28
Incidence of injection site reactions and adverse events
Product tolerance will be assessed by collection of Injection Site Reactions (ISRs) after each injection session and of Adverse Events (AEs) throughout the study
Measured: Through study completion, an average of 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start28 Feb 2023
- Primary completion31 Dec 2023
- Study completion1 Feb 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zunaid M. ALLI, MD, Principal investigator, Harley Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809739
- Sponsor's protocol ID
- VIV-STYL-HYD-01
- Other IDs
- 21E3942
- Acronym
- FLASH
- Status last verified
- Feb 2024
- First submitted
- 17 Feb 2023
- Last updated
- 16 Feb 2024
- 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 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLASH Study: Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck
- ClinicalTrials.gov ID
- NCT05809739
- Acronym / sponsor ID
- FLASH / VIV-STYL-HYD-01
- Conditions
- Aging
- Keywords
- hyaluronic acid, Injection, Healthy subjects, Prospective, Single arm, ISR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 12 Apr 2023 (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.
FLASH Study is a Post-Market Follow-Up PCMF designed to evaluate the tolerance and efficacy of STYLAGE Hydro by using a satisfaction questionnaire.
Detailed description
This is a prospective, in open, single arm and multicentric study designed to evaluate the tolerance and efficacy of STYLAGE Hydro.
Patients will be injected up to 2 mL of STYLAGE Hydro per area at each session. Three injection sessions 2 weeks apart are planned: one at visit 1 (D0), one at visit 2 (W2) and one at visit 3 (W4).
Proportions of subjects who are satisfied on the face 6 weeks after treatment initiation will be assessed. For each question of the questionnaire, the subjects who are satisfied are defined as subjects who rated "Somewhat agree", "Agree" or "Totally agree". Global aesthetic improvement according to independent evaluator and subjects' satisfaction will also be done during other visits. Safety parameters will be evaluated during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: STYLAGE HydroDevice: STYLAGE® Hydro 1 mL up to 2.0 mL per area will be injected in the face, neckline and neck (optionally) at each injection session. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy subject.
- Sex: female.
- Age: between 30 and 70 years.
- Subject having given freely and expressly her informed consent and data privacy consent.
- Subject with signs of cutaneous dryness and lack of elasticity on the face, on the neckline area and if applicable on the neck (if neck is planned to be treated) following investigator assessment.
Key exclusion criteria (28 listed)
- Pregnant or breastfeeding woman or planning a pregnancy during the study.
- Subject with a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject participating to another research on human beings or who is in an exclusion period of one.
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 Hydro3 sessions of injections (J0, J14 and J28) | Device | Treatment Group |
Primary outcome
Subject's satisfaction with STYLAGE® HYDRO on the face
Time frame: 6 weeks after treatment initiation
Proportions of subjects who are satisfied after treatment using a questionnaire (question 1 to 7)
15 secondary outcomes
Subject's satisfaction with STYLAGE® HYDRO on the face
Time frame: 6, 9 and 12 weeks after treatment initiation
Subject's satisfaction with STYLAGE® HYDRO on the neckline area and if applicable on the neck
Time frame: 6, 9 and 12 weeks after treatment initiation
Investigator's satisfaction on the face, the neckline area and if applicable on the neck
Time frame: 6 and12 weeks after treatment initiation
Effectiveness of STYLAGE® HYDRO in improving the subject's aesthetic appearance on the face, the neckline area and if applicable the neck
Time frame: 6, 9 and 12 weeks after treatment initiation for subject and at 7 and 12 weeks after treatment initiation for investigator
Effectiveness of STYLAGE® HYDRO on skin thickness on the face and neckline area
Time frame: 6 and 12 weeks after treatment initiation
Effectiveness of STYLAGE® HYDRO on skin density on the face and neckline area
Time frame: 6 and 12 weeks after treatment initiation
Mean change in average roughness on the face
Time frame: 6 and 12 weeks after treatment initiation
Mean change in average height of the roughness on the face
Time frame: 6 and 12 weeks after treatment initiation
Mean change in maximum height of the roughness profile on the face
Time frame: 6 and 12 weeks after treatment initiation
Mean change in arithmetic mean height of the roughness on the face and neckline area
Time frame: 6 and 12 weeks after treatment initiation
Mean change in root mean square height of roughness on the face and neckline area
Time frame: 6 and 12 weeks after treatment initiation
Mean change in ratio of the developed interfacial area on the face and neckline area
Time frame: 6 and 12 weeks after treatment initiation
Mean change in the depth of crow's feet wrinkles
Time frame: 6 and 12 weeks after treatment initiation
Injection pain with STYLAGE® HYDRO
Time frame: Day 0, Day 14 and Day 28
Incidence of injection site reactions and adverse events
Time frame: Through study completion, an average of 14 weeks
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 16 Feb 2024.
- 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.
Zunaid M. ALLI, MD principal investigator
Harley Street Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STYLAGE Hydro in people with Aging, run by Laboratoires Vivacy at 2 sites 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 12 inclusion and 28 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 16 Feb 2024. 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 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?
Subject's satisfaction with STYLAGE® HYDRO on the face (time frame: 6 weeks after treatment initiation). 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 16 Feb 2024.