NCT05235126

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Bohus Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Conditions

• Correction of Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	Decoria intense	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).

Timeline

• Start date: 2022-02-17
• Primary completion: 2023-03-03
• Completion: 2023-03-03
• First posted: 2022-02-11
• Last updated: 2026-03-27

Locations

2 sites across 1 country: Sweden