Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck

NCT05809739 | Completed

• 2 other identifiers: VIV-STYL-HYD-0121E3942
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Aging

Keywords

hyaluronic acid; Injection; Healthy subjects; Prospective; Single arm; ISR

Outcome Measures

Primary Outcomes (1)

• Subject's satisfaction with STYLAGE® HYDRO on the face

  Proportions of subjects who are satisfied after treatment using a questionnaire (question 1 to 7)

  6 weeks after treatment initiation

Secondary Outcomes (15)

• Subject's satisfaction with STYLAGE® HYDRO on the face

  6, 9 and 12 weeks after treatment initiation

• Subject's satisfaction with STYLAGE® HYDRO on the neckline area and if applicable on the neck

  6, 9 and 12 weeks after treatment initiation

• Investigator's satisfaction on the face, the neckline area and if applicable on the neck

  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

  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

  6 and 12 weeks after treatment initiation

Study Arms (1)

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.

Device: STYLAGE Hydro

Interventions

STYLAGE Hydro DEVICE

3 sessions of injections (J0, J14 and J28)

Treatment Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 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)
• 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 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.

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (2)

Eurofins Dermscan

Aix-en-Provence, 13290, France

Location

Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

Location

Study Officials

• Zunaid M. ALLI, MD

  Harley Street Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: April 12, 2023
• Study Start: February 28, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 1, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)