AgingHYDRELANCT04088006
The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity
A study testing Injection of STYLAGE® HydroMax in people with Aging, run by Laboratoires Vivacy at 1 site in France.
Trial summary
STYLAGE® HydroMax is a CE-marketed hyaluronic acid gel intended to improve skin moisturization and elasticity through injection into the dermis of the face, neck, neckline area and back of the hand. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Injection of STYLAGE® HydroMax
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2019to 8 Jul 2020
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject.
- Female between 35 and 65 years.
- Having given freely and expressly her informed consent.
- With signs of cutaneous dryness on the cheeks and neckline area (checked by measurements using Corneometer® <60 arbitrary unit (AU) on each cheek).
- With signs of a mild to moderate lack of elasticity on face and neckline area following investigator assessment.
- Psychologically able to understand the study related information and to give a written informed consent.
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- Affiliated to a health social security system.
- Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study.
- Agreeing not to change any hormonal treatment (including contraceptive treatment) during the whole study.
- Agreeing to keep their usual cleansing / care products during the whole study period.
- Agreeing to apply a sun protection factor SFP50 cream during non-intensive exposure to sunlight.
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study.
- With a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
- Who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- In a social or sanitary establishment.
- Having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
- Participating to another research on human beings or who is in an exclusion period of one.
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- Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
- Suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- With known history of or suffering from autoimmune disease and/or immune deficiency.
- 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.
- Having history of severe allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or to one of the component of the tested device, antiseptic solution or anaesthesia product if applicable.
- With fructose intolerance.
- With a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats.
- Predisposed to keloids or hypertrophic scarring.
- Prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- Having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the cheeks or the neckline area within the past 12 months prior to study start.
- Having received injection with a resorbable filling product in the cheeks or the neckline area within the past 18 months prior to study start.
- 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), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …).
- Having received at any time a treatment with tensor threads on the face or the neckline area.
- Having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to study start.
- Using medication such as aspirin, NSAIDs (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants, vitamin C within one week prior to study start and agreeing not to take such treatments within 1 week prior to the second and third injections or being a chronic user.
- 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, Monocentric, Intra-individual, Randomized Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® HydroMax on Skin Moisturization and Elasticity
STYLAGE® HydroMax is a CE-marketed hyaluronic acid gel intended to improve skin moisturization and elasticity through injection into the dermis of the face, neck, neckline area and back of the hand. In this study, 47 female healthy subjects between the ages of 35 and 65, who have signs of cutaneous dryness and lack of elasticity on the cheek and on the neckline area, who have given her informed consent and met all the eligibility criteria, will be enrolled. One month apart subjects will randomly receive 3 injections of product in one cheek and in one side of the neckline area. Subjects will come to a total of 8 visits over a period of 9 months. Variation of moisturization, elasticity and roughness of treated areas in comparison with non-treated areas will be measured using specific devices by independent evaluators. Global aesthetic improvement, subject satisfaction, pain at injection and safety will also be assessed.
Read the detailed description
This is a prospective, single center, randomized, intra-individual study with blinded evaluators assessing the efficacy and safety of STYLAGE® HydroMax on skin moisturization and elasticity on the cheek and neckline area. Forty seven female subjects will be enrolled and will receive 3 injections of product one month apart on the cheek and neckline area in a randomized fashion with the contralateral non-treated cheek and neckline area. Injection will be performed into the mid to deep dermis of the cheek and neckline area (1 mL per session and per area) by micro-papular injection technique. Subjects will be followed up at 1, 2, 3, 4, 6 and 9 months timepoints. Variation of moisturization, elasticity and roughness of treated areas in comparison with non-treated areas will be measured using Corneometer®, Cutometer®, Dermatop® or Primos Lite® respectively. Global aesthetic improvement, subject satisfaction, pain at injection and safety will also be assessed.
- Conditions
- Aging
- Being tested
- Injection of STYLAGE® HydroMax
- Keywords
- Aging, Skin dryness, Skin elasticity, Hyaluronic acid, Injection, Cheek, Neckline area, Healthy subjects, Intra-individual, Independent evaluators, Prospective, Randomized study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of STYLAGE® HydroMaxDevice
Also called Injection of hyaluronic acid gel
STYLAGE® HydroMax is a hyaluronic acid injectable gel intended to improve skin moisturization and elasticity of the face and neckline area in this study.
A total of 3 injection sessions will be performed one month apart for each subject.
At each injection session, 1 mL of product will be injected in the mid to deep dermis of one cheek and another 1 mL in one site of neckline area for each subject.
| Study group | Role | What they receive |
|---|---|---|
| Treated cheek and neckline area | Experimental | Intra-individual study with one cheek and one side of neckline area treated Receives: Device: Injection of STYLAGE® HydroMax |
| Non-treated cheek and neckline area | No intervention | Intra-individual study with one cheek and one side of neckline area non-treated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of cheek cutaneous moisturization
Variation from baseline before treatment (D0) to 3 months after treatment initiation of the cutaneous moisturization on the cheek, in comparison with the non-treated cheek, by an independent evaluator using Corneometer®.
Measured: Month 3
Secondary outcomes (9)
Variation of cheek cutaneous moisturization
Variation from baseline to 1, 2, 4, 6 and 9 months after treatment initiation of the cutaneous moisturization on the cheek in comparison with the non-treated cheek by a blinded independent evaluator using Corneometer®.
Measured: Month 1, Month 2, Month 4, Month 6, Month 9
Variation of neckline area cutaneous moisturization
Variation from baseline to 1, 2, 3, 4, 6 and 9 months after treatment initiation of the cutaneous moisturization on the neckline area in comparison with the non-treated neckline area by a blinded independent evaluator using Corneometer®.
Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Variation of cheek and neckline area cutaneous elasticity
Variation from baseline to 1, 2, 3, 4, 6 and 9 months after treatment initiation of the cutaneous elasticity on the cheek and neckline area in comparison with the non-treated cheek and neckline area by a blinded independent evaluator using Cutometer®.
Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Variation of cheek cutaneous roughness
Variation from baseline to 1, 2, 3, 4, 6 and 9 months after treatment initiation of the cutaneous roughness on the cheek in comparison with the non-treated cheek by a blinded independent evaluator using Dermatop®.
Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Variation of neckline area cutaneous roughness
Variation from baseline to 1, 2, 3, 4, 6 and 9 months after treatment initiation of the cutaneous roughness on the neckline area in comparison with the non-treated neckline area by a blinded independent evaluator using Primos Lite®.
Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Evaluation of global aesthetic improvement
Evaluation by the subject and by the blinded independent evaluator of the global aesthetic improvement of treated and non-treated zones 1, 2, 3, 4, 6 and 9 months after treatment initiation using the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a 5-score scale (from score 1 to score 5) with minimum scores representing a better outcome. Score 1 corresponds to "Very much improved", score 2 to "Much improved", score 3 to "Improved", score 4 to "No change" and score 5 to "Worse".
Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Evaluation of subject's satisfaction
Evaluation of subject's satisfaction 1, 2, 3, 4, 6 and 9 months after treatment initiation using a questionnaire.
Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Evaluation of pain during injection
Evaluation of the pain during injection by the subject using a numerical rating scale from 0 to 10.
Measured: Day 0, Month 1, Month 2
Report of adverse events
Evaluation of product tolerance by collection of adverse events assessed by subject and independent evaluator.
Measured: Up to Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start3 Sep 2019
- Primary completion10 Jan 2020
- Study completion8 Jul 2020
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
- Intra-individual study with treatment of one cheek and one side of neckline area per subject in a randomly fashion. Variation of moisturization, elasticity and roughness between treated areas and non-treated areas of each subject measured at different study timepoints.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sophie CONVERSET-VIETHEL, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088006
- Sponsor's protocol ID
- 2018-A02934-51
- Acronym
- HYDRELA
- Status last verified
- Aug 2020
- First submitted
- 6 Sep 2019
- Last updated
- 4 Aug 2020
- 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 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Monocentric, Intra-individual, Randomized Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® HydroMax on Skin Moisturization and Elasticity
- ClinicalTrials.gov ID
- NCT04088006
- Acronym / sponsor ID
- HYDRELA / 2018-A02934-51
- Conditions
- Aging
- Keywords
- Aging, Skin dryness, Skin elasticity, Hyaluronic acid, Injection, Cheek, Neckline area, Healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 12 Sep 2019 (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.
STYLAGE® HydroMax is a CE-marketed hyaluronic acid gel intended to improve skin moisturization and elasticity through injection into the dermis of the face, neck, neckline area and back of the hand. In this study, 47 female healthy subjects between the ages of 35 and 65, who have signs of cutaneous dryness and lack of elasticity on the cheek and on the neckline area, who have given her informed consent and met all the eligibility criteria, will be enrolled. One month apart subjects will randomly receive 3 injections of product in one cheek and in one side of the neckline area. Subjects will come to a total of 8 visits over a period of 9 months. Variation of moisturization, elasticity and roughness of treated areas in comparison with non-treated areas will be measured using specific devices by independent evaluators. Global aesthetic improvement, subject satisfaction, pain at injection and safety will also be assessed.
Detailed description
This is a prospective, single center, randomized, intra-individual study with blinded evaluators assessing the efficacy and safety of STYLAGE® HydroMax on skin moisturization and elasticity on the cheek and neckline area. Forty seven female subjects will be enrolled and will receive 3 injections of product one month apart on the cheek and neckline area in a randomized fashion with the contralateral non-treated cheek and neckline area. Injection will be performed into the mid to deep dermis of the cheek and neckline area (1 mL per session and per area) by micro-papular injection technique. Subjects will be followed up at 1, 2, 3, 4, 6 and 9 months timepoints. Variation of moisturization, elasticity and roughness of treated areas in comparison with non-treated areas will be measured using Corneometer®, Cutometer®, Dermatop® or Primos Lite® respectively. Global aesthetic improvement, subject satisfaction, pain at injection and safety will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intra-individual study with treatment of one cheek and one side of neckline area per subject in a randomly fashion. Variation of moisturization, elasticity and roughness between treated areas and non-treated areas of each subject measured at different study timepoints.
| Arm | Type | Receives |
|---|---|---|
| Treated cheek and neckline area | Experimental | Device: Injection of STYLAGE® HydroMaxIntra-individual study with one cheek and one side of neckline area treated |
| Non-treated cheek and neckline area | No intervention | –Intra-individual study with one cheek and one side of neckline area non-treated |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy subject.
- Female between 35 and 65 years.
- Having given freely and expressly her informed consent.
- With signs of cutaneous dryness on the cheeks and neckline area (checked by measurements using Corneometer® <60 arbitrary unit (AU) on each cheek).
- With signs of a mild to moderate lack of elasticity on face and neckline area following investigator assessment.
Key exclusion criteria (25 listed)
- Pregnant or nursing woman or planning a pregnancy during the study.
- With a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
- Who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- In a social or sanitary establishment.
- Having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
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 |
|---|---|---|
| Injection of STYLAGE® HydroMaxAlso: Injection of hyaluronic acid gelSTYLAGE® HydroMax is a hyaluronic acid injectable gel intended to improve skin moisturization and elasticity of the face and neckline area in this study. A total of 3 injection sessions will be performed one month apart for each subject. At each injection session, 1 mL of product will be injected in the mid to deep dermis of one cheek and another 1 mL in one site of neckline area for each subject. | Device | Treated cheek and neckline area |
Primary outcome
Variation of cheek cutaneous moisturization
Time frame: Month 3
Variation from baseline before treatment (D0) to 3 months after treatment initiation of the cutaneous moisturization on the cheek, in comparison with the non-treated cheek, by an independent evaluator using Corneometer®.
9 secondary outcomes
Variation of cheek cutaneous moisturization
Time frame: Month 1, Month 2, Month 4, Month 6, Month 9
Variation of neckline area cutaneous moisturization
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Variation of cheek and neckline area cutaneous elasticity
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Variation of cheek cutaneous roughness
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Variation of neckline area cutaneous roughness
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Evaluation of global aesthetic improvement
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Evaluation of subject's satisfaction
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Evaluation of pain during injection
Time frame: Day 0, Month 1, Month 2
Report of adverse events
Time frame: Up to Month 9
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 4 Aug 2020.
- 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.
Sophie CONVERSET-VIETHEL, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of STYLAGE® HydroMax 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 11 inclusion and 25 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 4 Aug 2020. 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?
Variation of cheek cutaneous moisturization (time frame: Month 3). 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 4 Aug 2020.