Active — Not RecruitingNot Applicable

Clinical Investigation on Lips Treated With HA-filler

Sweden100 participantsStarted 2024-12-09

Plain-language summary

A post-market-clinical follow-up investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 lips amenable to an improvement of at least 1 grade on the GAIS. At least one lip should either have a potential to change (augmentation, contouring or both) or have moderate to severe volume deficit. The grades do not have to be the same on both lips.
✓. 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 anaesthetic 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 to measure the change/improvement in score using the Global Aesthetic Improvement Scale (GAIS)

Timeframe: From pre-intervention baseline (Visit 1, Day 0) to month 3 (Visit 3, Day 90).

Primary safety endpoint by evaluating Adverse Events

Timeframe: From inclusion until the end of the study (6 months)

Trial details

NCT IDNCT07188818

SponsorBohus Biotech AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Aesthetic Correction of the Lips trials