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

NCT ID: NCT04546516

Last Updated: 2023-03-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-08

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dermal Filler

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Dermal filler injection to different facial areas

Interventions

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HYAcorp Lips and HYAcorp Face

Dermal filler injection to different facial areas

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HeiMed

UNKNOWN

Sponsor Role collaborator

BioSCIENCE GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BioSCIENCE Investigation Site #01

Bad Honnef, , Germany

Site Status

BioSCIENCE Investigation Site #02

Kempten, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CIP HYAcorp Lips and Face

Identifier Type: -

Identifier Source: org_study_id

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