Safety and Efficacy of the HA-based Dermal Fillers HYAPROF® SOFT and HYAPROF® BALANCE (PMCF_HYAPROF)

March 16, 2023 updated by: BioSCIENCE GmbH

Prospective Observational Clinical Trial for Safety and Efficacy of HYAPROF® SOFT and HYAPROF® BALANCE

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Honnef, Germany
        • BioSCIENCE Investigation Site #01
      • Kempten, Germany
        • BioSCIENCE Investigation Site #02

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HYAPROF® SOFT
HYAPROF® SOFT is indicated for volume replacement (filling of folds), fine to medium folds, lip augmentation, periorbital region.
Device: HYAPROF® SOFT and HYAPROF® BALANCE
Dermal filler injection to different facial areas
HYAPROF® BALANCE
HYAPROF® BALANCE is indicated for volume replacement (filling of folds), deep folds, nasolabial folds, cheek area, glabella folds. It is not intended for injection to the periorbital region (eyelid, crow's feet, circles under the eyes).
Device: HYAPROF® SOFT and HYAPROF® BALANCE
Dermal filler injection to different facial areas

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months
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
6 months
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
3 months
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
6 months
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
3 months
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Product safety immediately after the treatment
Time Frame: Immediately after the treatment
Side effects and adverse event recording; degree of severity: mild, moderate, severe
Immediately after the treatment
Product safety 4 weeks
Time Frame: 4 weeks
Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
4 weeks
Product safety 3 months
Time Frame: 3 months
Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
3 months
Product safety 6 months
Time Frame: 6 months
Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioSCIENCE GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HeiMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP HYAPROF SOFT and BALANCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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