Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04546516
Other study ID # CIP HYAcorp Lips and Face
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 8, 2020
Est. completion date December 31, 2022

Study information

Verified date March 2023
Source BioSCIENCE GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 167
Est. completion date December 31, 2022
Est. primary completion date January 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HYAcorp Lips and HYAcorp Face
Dermal filler injection to different facial areas

Locations

Country Name City State
Germany BioSCIENCE Investigation Site #01 Bad Honnef
Germany BioSCIENCE Investigation Site #02 Kempten

Sponsors (2)

Lead Sponsor Collaborator
BioSCIENCE GmbH HeiMed

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months
Primary 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 6 months
Primary 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 3 months
Primary 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 6 months
Primary 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 3 months
Primary 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 6 months
Secondary Product safety immediately after the treatment Side effects and adverse event recording; degree of severity: mild, moderate, severe Immediately after the treatment
Secondary Product safety 4 weeks Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event 4 weeks
Secondary Product safety 3 months Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event 3 months
Secondary Product safety 6 months Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event 6 months
See also
  Status Clinical Trial Phase
Completed NCT04546152 - Safety and Efficacy of the HA-based Dermal Fillers HYAPROF® SOFT and HYAPROF® BALANCE
Active, not recruiting NCT05694286 - A Prospective Evaluation of Infraorbital Filler Injection N/A
Completed NCT02654522 - The Use of a Recombinant DNA-based Hyaluronidase to Dissolve Fixed Amounts of Hyaluronic Acid Dermal Fillers Phase 1
Completed NCT05822778 - Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation N/A
Completed NCT05294562 - China Post-Market Clinical Follow-up of FACILLE®
Completed NCT04569045 - Evaluate the Safety and Effectiveness of Sodium Hyaluronate When Used for the Correction of Nasolabial Folds N/A
Completed NCT04622085 - The Evaluation of the Safety and Effectiveness of ANIMERS Chiara LA and JUVÉDERM VOLUMA® for Aging Mid-Face N/A
Completed NCT04599335 - The Evaluation of the Safety and Effectiveness of a Novel Gel-type Sodium Hyaluronate for the Correction of Aging Mid-face N/A
Recruiting NCT05853224 - An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel N/A