A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds (NLF) — Decorate01

Correction of Nasolabial Folds Clinical Trial

Official title:
A Post-market, Prospective, Observational (Non-interventional), Partly Confirmatory, Multi-centre Clinical Investigation to Confirm the Clinical Safety and Performance Profile of Decoria® Intense Hyaluronic Acid Dermal Filler for the Correction of Nasolabial Folds.

Status Completed

Clinical Trial Summary

Decoria intense is a class III medical device and is CE-marked and has been on the market since 2014. Decoria intense is a hyaluronic acid filler that will be used according to intended use for correction of nasolabial folds. According to the new MDR in EU this clinical investigation will confirm efficacy and safety of Decoria intense. The plan is to recruit 80 subjects to receive 64 evaluable subjects during 6 months recruitment. The clinical investigation contains 5 visits and the total time per subject is 12 months. All subjects will receive treatment at Visit 1 with the option to receive a touch-up treatment at Visit 2. Evaluation of the nasolabial folds will be performed by PI using the Wrinkle Severity Rating Scale (WSRS)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Correction of Nasolabial Folds

Clinical Trial Details

NCT number	NCT05235126
Study type	Interventional
Source	Bohus Biotech AB
Contact
Status	Completed
Phase	N/A
Start date	February 17, 2022
Completion date	March 3, 2023

View Details

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