Investigation of Decoria® Intense Strong for improving jawline profile

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

This study is testing if Decoria® Intense Strong can safely improve the jawline shape for people looking to enhance their facial contour.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bohus Biotech AB (Industry-sponsored)
• Locations: 7 sites (Göteborg and 6 other locations)
• Trial ID: NCT06562075 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to confirm the safety and performance of Decoria® Intense Strong in enhancing jawline contour. It is a post-market, open-label, prospective, interventional study that involves multiple centers. Participants will receive treatment and undergo follow-up assessments over a period of 9 months, including standardized facial photography and evaluations of patient satisfaction. The study will also measure pain levels associated with the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who seek enhancement of their jawline contour and can provide informed consent.

Not a fit: Patients who are pregnant, lactating, or have a history of hypersensitivity to the treatment components may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide patients with a safe and effective option for improving their jawline profile.

How similar studies have performed: Other studies involving similar injectable treatments have shown positive outcomes, suggesting potential for success in this investigation.

Eligibility criteria

Inclusion Criteria:

1. Adults ≥18 years, males and females.
2. Able and willing to give written informed consent for participation in the investigation.
3. 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.
4. Ability to follow study instructions and likely to complete all required visits.

Exclusion Criteria:

1. Pregnant or lactating females.
2. Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anesthetic products.
3. 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.
4. 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.
5. Has an ongoing episode/relapse, recently diagnosed or newly started medication of an autoimmune disease, as judged by the investigator.
6. Has any chronic or acute skin disease or inflammation (such as pimples, rashes or hives) within or close to the treatment area.
7. Has any treatments (thrombolytics, anticoagulants etc) or disease related to the coagulation system.
8. Subjects that have taken any type of vaccine within two weeks prior injection with the IMD.
9. Patients receiving interferon and ribavirin treatment.
10. Features that may interfere with the visual assessment such as recent cosmetic treatment, scarring, abscess, piercing or tattoo.
11. Participation in a clinical investigation that may affect the safety or performance of this investigation, as judged by the Principal Investigator, or authorized designee.
12. Employees of the study site or the sponsor directly involved with the conduct of the investigation.

Where this trial is running

Göteborg and 6 other locations

• Inskinity — Göteborg, Sweden (Not_yet_recruiting)
• Göteborg Laser & Estetik — Göteborg, Sweden (Not_yet_recruiting)
• Svenska Hudkliniker — Karlstad, Sweden (Not_yet_recruiting)
• Inskinity — Stockholm, Sweden (Not_yet_recruiting)
• Florakliniken — Stockholm, Sweden (Not_yet_recruiting)
• The Faculty — Stockholm, Sweden (Recruiting)
• Svenska Hudkliniker — Stockholm, Sweden (Recruiting)

Study contacts

• Principal investigator: Lucian Grema, M.D — Florakliniken, Stockholm, Sweden
• Study coordinator: Maria Lindgren, PhD

Conditions Jawline Contour Deficit; jawline profile