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Completed

NCT Number: NCT04546516

Safety and Efficacy of the HA-based Dermal Fillers HYAcorp Lips and Face

Purpose of this study is the demonstration of safety and efficacy of the dermal fillers HYAcorp Lips and HYAcorp Face for restoration of the facial volume and contour.

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Key information

Conditions

Dermal Filler

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BioSCIENCE Investigation Site #01, Bad Honnef, Germany

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About this study

This is a prospective, multicenter, observational, open label, two-arm, crossover, PMCF clinical trial for demonstration of the safety and efficacy of the HA-based dermal fillers HYAcorp Lips and HYAcorp Face for restoration of the facial volume and contour. Besides safety aspects, evaluated immediately after the treatment, 4 weeks, 3 and 6 months after the treatment, the performance of the demal fillers are evaluated in the 3 and 6 months follow-up by using GAIS and WSRS.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects intended for the treatment with HYAcorp Lips and/or Face according to the instructions for use of the product
  • decision for the treatment with HYAcorp Lips and/or Face was made before the subject was recruited for the clinical trial
  • subjects signed written informed consent
  • adult subjects at least 18 years old
  • all Fitzpatrick skin types
  • area treated with one investigational device - no combination of products in one treatment area

Exclusion criteria

  • tendency to hypertrophic and keloid scarring
  • intolerance to gram-positive bacteria
  • prone to active inflammatory or infectious processes
  • suffering from acute or chronic skin diseases
  • undergoing anti-coagulant therapy
  • known allergy to hyaluronic acid
  • suffering from autoimmune diseases
  • multiple allergies
  • pregnancy or lactating women
  • subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits

Treatment and study plan

HYAcorp Lips and HYAcorp Face

Device

Dermal filler injection to different facial areas

Primary outcomes

  1. Global aesthetic improvement 3 months

    Time frame: 3 months

    Global aesthetic improvement assessment acc. to the Global Aesthetic Improvement Scale (GAIS); 3: very much improved, 2: much improved, 1: improved, 0 unchanged, -1: worse

  2. Global aesthetic improvement 6 months

    Time frame: 6 months

    Global aesthetic improvement assessment acc. to the Global Aesthetic Improvement Scale (GAIS); 3: very much improved, 2: much improved, 1: improved, 0 unchanged, -1: worse

  3. Wrinkle severity assessment 3 months

    Time frame: 3 months

    Wrinkle severity assessment acc. to the Wrinkle Severity Rating Scale (WSRS); 1: wrinkles absent, 2: slight wrinkles, 3: moderate wrinkles, 4: severe wrinkles, 5: very severe wrinkles

  4. Wrinkle severity assessment 6 months

    Time frame: 6 months

    Wrinkle severity assessment acc. to the Wrinkle Severity Rating Scale (WSRS); 1: wrinkles absent, 2: slight wrinkles, 3: moderate wrinkles, 4: severe wrinkles, 5: very severe wrinkles

  5. Number of subjects with wrinkle severity improvement 3 months

    Time frame: 3 months

    Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline

  6. Number of subjects with wrinkle severity improvement 6 months

    Time frame: 6 months

    Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline

Secondary outcomes

  1. Product safety immediately after the treatment

    Time frame: Immediately after the treatment

    Side effects and adverse event recording; degree of severity: mild, moderate, severe

  2. Product safety 4 weeks

    Time frame: 4 weeks

    Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event

  3. Product safety 3 months

    Time frame: 3 months

    Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event

  4. Product safety 6 months

    Time frame: 6 months

    Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event

Sponsors and collaborators

Lead sponsor

BioSCIENCE GmbH

Industry

Collaborators

  • HeiMed

Registry information

Official study title

Prospective Observational Clinical Trial for Safety and Efficacy of HYAcorp Lips and HYAcorp Face

Acronym: PMCF_HYAcorp

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2020
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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