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

NCT04546152 | Completed DMC

• 1 other identifier: CIP HYAPROF SOFT and BALANCE
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 2

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.

Conditions

Dermal Filler

Keywords

Volume Replacement; Facial Filler; Soft Tissue Filler; Hyaluronic Acid

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Product safety immediately after the treatment

  Immediately after the treatment

• Product safety 4 weeks

  4 weeks

• Product safety 3 months

  3 months

• Product safety 6 months

  6 months

Study Arms (2)

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

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

Interventions

HYAPROF® SOFT and HYAPROF® BALANCE DEVICE

Dermal filler injection to different facial areas

HYAPROF® BALANCE; HYAPROF® SOFT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioSCIENCE GmbH: lead
• HeiMed: collaborator

Study Sites (2)

BioSCIENCE Investigation Site #01

Bad Honnef, Germany

Location

BioSCIENCE Investigation Site #02

Kempten, Germany

Location

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 11, 2020
• Study Start: September 16, 2020
• Primary Completion: January 22, 2022
• Study Completion: December 31, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)