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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546516
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : December 24, 2020
Sponsor:
Collaborator:
HeiMed
Information provided by (Responsible Party):
BioSCIENCE GmbH

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Dermal Filler Device: HYAcorp Lips and HYAcorp Face

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 132 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Prospective Observational Clinical Trial for Safety and Efficacy of HYAcorp Lips and HYAcorp Face
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : July 31, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
HYAcorp Lips
HYAcorp Lips is indicated for the restoration of volume and contour of the lips.
 Device: HYAcorp Lips and HYAcorp Face
Dermal filler injection to different facial areas
HYAcorp Face
HYAcorp Face is indicated for volume replacement (filling of folds), medium to deep folds, nasolabial folds, cheek area, glabella. It is not intended for injection to the periorbital region (eyelid, crow's feet, circles under the eyes).
 Device: HYAcorp Lips and HYAcorp Face
Dermal filler injection to different facial areas


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects intended for the treatment with HYAcorp Lips and Face according to the instructions for use of the products.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546516


Contacts
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Contact: Clinical Trial Registry & Maintenance Team: CRO@heimed.de
Contact: Study Principle Investigator: LCI.PMCF_HYAcorp@heimed.de

Locations
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Germany
BioSCIENCE Investigation Site #01 Recruiting
Bad Honnef, Germany
Contact: Study Principle    Investigator    LCI.PMCF_HYAcorp@heimed.de   
BioSCIENCE Investigation Site #02 Recruiting
Kempten, Germany
Contact: Study Principle    Investigator    LCI.PMCF_HYAcorp@heimed.de   
Sponsors and Collaborators
BioSCIENCE GmbH
HeiMed
More Information
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Responsible Party: BioSCIENCE GmbH
ClinicalTrials.gov Identifier: NCT04546516    
Other Study ID Numbers: CIP HYAcorp Lips and Face
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by BioSCIENCE GmbH:
Volume Replacement
Facial Filler
Soft Tissue Filler
Hyaluronic Acid