Clinical trial NCT04546152: Safety and Efficacy of the HA-based Dermal Fillers HYAPROF® SOFT and HYAPROF® BALANCE
Official title: Prospective Observational Clinical Trial for Safety and Efficacy of HYAPROF® SOFT and HYAPROF® BALANCE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermal Filler
Keywords: Volume Replacement
Facial Filler
Soft Tissue Filler
Hyaluronic Acid
Lead sponsor: BioSCIENCE GmbH
Sponsor class: INDUSTRY
Collaborators: name: HeiMed
First posted: 2020-09-11
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects intended for the treatment with HYAPROF® SOFT and BALANCE according to the instructions for use of the products.

Brief summary: Purpose of this study is the demonstration of safety and efficacy of the dermal fillers HYAPROF® SOFT and HYAPROF® BALANCE for restoration of the facial volume and contour.

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 HYAPROF® SOFT and HYAPROF® BALANCE 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.

Eligibility criteria: Inclusion Criteria:

* subjects intended for the treatment with HYAPROF® SOFT and/or BALANCE according to the instructions for use of the product
* decision for the treatment with HYAPROF® SOFT and/or BALANCE 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 either with HYAPROF® SOFT or HYAPROF® BALANCE - no combination of the products in one treated 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

Primary outcomes:
measure: Global aesthetic improvement 3 months
timeFrame: 3 months
measure: Global aesthetic improvement 6 months
timeFrame: 6 months
measure: Wrinkle severity assessment 3 months
timeFrame: 3 months
measure: Wrinkle severity assessment 6 months
timeFrame: 6 months
measure: Number of subjects with wrinkle severity improvement 3 months
timeFrame: 3 months
measure: Number of subjects with wrinkle severity improvement 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Product safety immediately after the treatment
timeFrame: Immediately after the treatment
measure: Product safety 4 weeks
timeFrame: 4 weeks
measure: Product safety 3 months
timeFrame: 3 months
measure: Product safety 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Bad Honnef
country: Germany
facility: BioSCIENCE Investigation Site #01
city: Kempten
country: Germany
facility: BioSCIENCE Investigation Site #02
Study officials:
References: