Safety and Efficacy of the HA-based Dermal Fillers HYAcorp Lips and Face
NCT ID: NCT04546516
Last Updated: 2023-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
167 participants
OBSERVATIONAL
2020-09-08
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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HYAcorp Lips
HYAcorp Lips is indicated for the restoration of volume and contour of the lips.
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).
HYAcorp Lips and HYAcorp Face
Dermal filler injection to different facial areas
Interventions
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HYAcorp Lips and HYAcorp Face
Dermal filler injection to different facial areas
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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HeiMed
UNKNOWN
BioSCIENCE GmbH
INDUSTRY
Responsible Party
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Locations
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BioSCIENCE Investigation Site #01
Bad Honnef, , Germany
BioSCIENCE Investigation Site #02
Kempten, , Germany
Countries
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Other Identifiers
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CIP HYAcorp Lips and Face
Identifier Type: -
Identifier Source: org_study_id
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