CompletedNot Applicable

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

Sweden114 participantsStarted 2024-09-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Primary efficacy endpoint

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

Primary safety endpoint

Timeframe: From baseline to end of study (9 months)

Trial details

NCT IDNCT06562075

SponsorBohus Biotech AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-12

View on ClinicalTrials.gov More Jawline Contour Deficit trials