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

NCT06562075 | Completed

• 1 other identifier: CIV-24-03-046499
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Jawline Contour Deficit

Keywords

jawline profile

Outcome Measures

Primary Outcomes (2)

• Primary efficacy endpoint

  The primary efficacy endpoint is the blinded-evaluator assessment of improvement using the Global Aesthetic Improvement Scale (GAIS). GAIS is a comparative scale, based on assessment of change since before pre-intervention, ranges from 1 (exceptional improvement) to 4 (no change) and 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in the jawline according to the GAIS grading. Each side (left and right) will be assessed independently.

  From pre-intervention baseline, at Visit 3 (3 months post baseline).

• Primary safety endpoint

  The primary safety endpoint is to assess the safety of Decoria® Intense Strong, evaluated by the incidence, intensity, duration, and time of onset of related AEs, including injection site reactions, collected during the study duration.

  From baseline to end of study (9 months)

Secondary Outcomes (5)

• Secondary endpoint

  From baseline to visit 2 (1 month optional touch-up)

• Secondary endpoint

  90 days respectively 270 days after IMD injection

• Secondary endpoint

  90 days respectively 270 days after IMD injection

• Secondary endpoint

  30 days between visit 1 and visit 2

• Secondary endpoint

  30 days, 90 days and 270 days post-treatment

Study Arms (1)

Investigational Medical Device

OTHER

All eligable subjects desiring correction of their jawline profile will receive intradermal injection of Decoria Intense Strong on either one or both sides of the face (including or not including the chin).

Device: Decoria Intense Strong

Interventions

Decoria Intense Strong DEVICE

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

Investigational Medical Device

Eligibility Criteria

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

You may qualify if:

• Adults ≥18 years, males and females.
• Able and willing to give written informed consent for participation in the investigation.
• Treating investigator considers the subject's jaw (including or not including chin) amenable to an improvement of at least 1 grade on GAIS. At least one side with either potential to enhance contouring or moderate to severe loss of jawline definition. The grades do not have to be the same on both sides.
• Ability to follow study instructions and likely to complete all required visits.

You may not qualify if:

• Pregnant or lactating females.
• Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anesthetic products.
• Performed or planned surgery below the nose, permanent implant, injection with fat, and deoxycholic acid that may confound the evaluation of safety and performance of the IMD.
• Any other intradermal injection, such as semi-permanent fillers or botulinum toxins (no complications are allowed), received in the same injection area within 9 months of the Treatment visit (Visit 1) that may confound the evaluation of safety and performance of the IMD.
• Has an ongoing episode/relapse, recently diagnosed or newly started medication of an autoimmune disease, as judged by the investigator.
• Has any chronic or acute skin disease or inflammation (such as pimples, rashes or hives) within or close to the treatment area.
• Has any treatments (thrombolytics, anticoagulants etc) or disease related to the coagulation system.
• Subjects that have taken any type of vaccine within two weeks prior injection with the IMD.
• Patients receiving interferon and ribavirin treatment.
• Features that may interfere with the visual assessment such as recent cosmetic treatment, scarring, abscess, piercing or tattoo.
• Participation in a clinical investigation that may affect the safety or performance of this investigation, as judged by the Principal Investigator, or authorized designee.
• Employees of the study site or the sponsor directly involved with the conduct of the investigation.

Sponsors & Collaborators

• Bohus Biotech AB: lead
• Key2Compliance: collaborator

Study Sites (7)

Inskinity

Gothenburg, 411 07, Sweden

Location

Göteborg Laser & Estetik

Gothenburg, 411 08, Sweden

Location

Svenska Hudkliniker

Karlstad, 652 25, Sweden

Location

Inskinity

Stockholm, 111 28, Sweden

Location

Florakliniken

Stockholm, 113 28, Sweden

Location

The Faculty

Stockholm, 114 46, Sweden

Location

Svenska Hudkliniker

Stockholm, Sweden

Location

Study Officials

• Lucian Grema, M.D

  Florakliniken, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: September 6, 2024
• Primary Completion: December 12, 2025
• Study Completion: December 25, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-01

Locations

SE (7)