Dermal FillerPMCF_HYAPROFNCT04546152
Safety and Efficacy of the HA-based Dermal Fillers HYAPROF® SOFT and HYAPROF® BALANCE
An observational study of Dermal Filler, run by BioSCIENCE GmbH at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermal Filler
- What is being tested?
- HYAPROF® SOFT and HYAPROF® BALANCE
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 170 participants
- Where
- 2 sitesGermany
- Study dates
- 16 Sep 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects intended for the treatment with HYAPROF® SOFT and BALANCE according to the instructions for use of the products.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
BioSCIENCE Investigation Site #01
Bad Honnef
BioSCIENCE Investigation Site #02
Kempten
About this study
Official title: 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.
Read the 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.
- Conditions
- Dermal Filler
- Being tested
- HYAPROF® SOFT and HYAPROF® BALANCE
- Keywords
- Volume Replacement, Facial Filler, Soft Tissue Filler, Hyaluronic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYAPROF® SOFT and HYAPROF® BALANCEDevice
Dermal filler injection to different facial areas
| Study group | Role | What they receive |
|---|---|---|
| HYAPROF® SOFT | HYAPROF® SOFT is indicated for volume replacement (filling of folds), fine to medium folds, lip augmentation, periorbital region. Receives: Device: HYAPROF® SOFT and HYAPROF® BALANCE | |
| 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). Receives: Device: HYAPROF® SOFT and HYAPROF® BALANCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global aesthetic improvement 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
Measured: 3 months
Global aesthetic improvement 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
Measured: 6 months
Wrinkle severity assessment 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
Measured: 3 months
Wrinkle severity assessment 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
Measured: 6 months
Number of subjects with wrinkle severity improvement 3 months
Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline
Measured: 3 months
Number of subjects with wrinkle severity improvement 6 months
Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline
Measured: 6 months
Secondary outcomes (4)
Product safety immediately after the treatment
Side effects and adverse event recording; degree of severity: mild, moderate, severe
Measured: Immediately after the treatment
Product safety 4 weeks
Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
Measured: 4 weeks
Product safety 3 months
Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
Measured: 3 months
Product safety 6 months
Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start16 Sep 2020
- Primary completion22 Jan 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermal FillerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSCIENCE GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HeiMed
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546152
- Sponsor's protocol ID
- CIP HYAPROF SOFT and BALANCE
- Acronym
- PMCF_HYAPROF
- Status last verified
- Mar 2023
- First submitted
- 26 Aug 2020
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Clinical Trial for Safety and Efficacy of HYAPROF® SOFT and HYAPROF® BALANCE
- ClinicalTrials.gov ID
- NCT04546152
- Acronym / sponsor ID
- PMCF_HYAPROF / CIP HYAPROF SOFT and BALANCE
- Conditions
- Dermal Filler
- Keywords
- Volume Replacement, Facial Filler, Soft Tissue Filler, Hyaluronic Acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- BioSCIENCE GmbHIndustry (pharma, biotech, devices)
- Collaborators
- HeiMed
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYAPROF® SOFT | – | Device: HYAPROF® SOFT and HYAPROF® BALANCEHYAPROF® SOFT is indicated for volume replacement (filling of folds), fine to medium folds, lip augmentation, periorbital region. |
| HYAPROF® BALANCE | – | Device: HYAPROF® SOFT and HYAPROF® BALANCEHYAPROF® 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects intended for the treatment with HYAPROF® SOFT and BALANCE according to the instructions for use of the products.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYAPROF® SOFT and HYAPROF® BALANCEDermal filler injection to different facial areas | Device | HYAPROF® BALANCE, HYAPROF® SOFT |
Primary outcome
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
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
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
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
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
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
4 secondary outcomes
Product safety immediately after the treatment
Time frame: Immediately after the treatment
Product safety 4 weeks
Time frame: 4 weeks
Product safety 3 months
Time frame: 3 months
Product safety 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermal Filler, run by BioSCIENCE GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global aesthetic improvement 3 months (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.