Clinical Trials in Sweden / NCT07188818
Active, not recruiting
Not applicable
Clinical Investigation on Lips Treated With HA-filler
NCT07188818 · tracked via the Priya Life Science Sweden tracker
Condition(s) studied
Aesthetic Correction of the Lips
Investigational drug(s) / intervention(s)
Decoria Essence
Decoria Essence: Decoria® Essence is a hyaluronic acid based, BDDE-crosslinked dermal filler. Decoria® Essence dermal fillers are injected into dermal tissue to improve the volume and the contouring of the lips to desired level of correction by supporting the overlying tissue. Injection volume will be determined by the treating investigator according to the instructions for Use (IFU).
Study 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.
Eligibility
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 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.
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 anaesthetic 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. Subjects receiving interferon and ribavirin treatment.
10. Features that may interfere with the visual assessment such as recent cosmetic treatment, scarring, abscess, piercing or tattoo below the nose.
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
Primary outcome measure(s)
- Primary efficacy endpoint to measure the change/improvement in score using the Global Aesthetic Improvement Scale (GAIS) — From pre-intervention baseline (Visit 1, Day 0) to month 3 (Visit 3, Day 90).
The primary efficacy endpoint is to measure the change/improvement in score from pre-treatment baseline to 3 months post treatment by an independent evaluator, 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 (unaltered) and 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in the lips according to the GAIS grading. Each lip (upper and lower) will be assessed independently. - Primary safety endpoint by evaluating Adverse Events — From inclusion until the end of the study (6 months)
The primary safety endpoint is to assess the safety of Decoria® Essence, evaluated by the incidence, intensity, duration, and time of onset of related adverse events (AEs), including injection site reactions, collected during study duration.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Advanced Clinic | Gothenburg | Sweden | |
| Svenska Hudkliniker Karlstad | Karlstad | Sweden | |
| Hansa Estetik | Malmö | Sweden | |
| Svenska Hudkliniker | Stockholm | Sweden | |
| Dr Filip | Stockholm | Sweden | |
| Peri Estetik | Västerås | Sweden |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07188818 on ClinicalTrials.gov ↗ ← All trials in Sweden