NCT06562075

A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Intense Strong

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Bohus Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A post-market Follow up clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile.

Detailed description

This will be a post-market, open label, prospective, interventional, confirmatory, evaluator-blinded,multi - centre, clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile. Subjects desiring correction of their jawline profile at the participating sites will be asked to participate in the clinical investigation. According to national legislation, all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers, as to allow for sufficient reflection time. If the subject decides to participate, the subject will receive treatment on Day 0 (Visit 1). At 1 month visit (Visit 2) an optional touch-up may be given as well as assessments performed. All subjects will be followed for 9 months with follow-up and assessments by visits (Visit 2, Visit 3 and Visit 5) and phone call (Visit 4). Standardized facial photography will be taken prior to and after treatment during Visit 1 and 2 and during each follow-up visit at the clinic (Visit 3 and Visit 5), for evaluation according to GAIS and the exploratory instrumental evaluation of jawline contour. GAIS will be used for blinded-evaluator assessment, treating Investigator assessment and patient satisfaction. Numeric Pain Rating Scale (NRS) at each visit involving an injection (Visit 1 and Visit 2 - optional touch up) will be used to measure pain.

Conditions

• Jawline Contour Deficit

Interventions

Type	Name	Description
DEVICE	Decoria Intense Strong	Decoria® Intense Strong is a HA-based, BDDE-crosslinked dermal filler. Decoria® Intense Strong dermal fillers are injected into dermal tissue to improve and define contouring of jawline profile, supporting overlying tissue to shape facial contours to desired level of correction. Appropriate injection volume for the jawline will be determined by the Treating investigator according to IFU

Timeline

• Start date: 2024-09-06
• Primary completion: 2025-12-12
• Completion: 2025-12-25
• First posted: 2024-08-20
• Last updated: 2026-03-27

Locations

7 sites across 1 country: Sweden