Clinical Investigation on Lips Treated With HA-filler (DAG-ESS)

Bohus Biotech

Status: Invitation-only

Conditions: Aesthetic Correction of the Lips

Treatments: Device: Decoria Essence

Study type: Interventional

Funder types: Industry

Identifiers

NCT07188818

CIV-24-04-046794

Details and patient eligibility

About

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.

Full description

A post-market, open-label, prospective, interventional, confirmatory, evaluator-blinded, multi - centre, clinical investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.

Subjects desiring correction and improvement of their lip profile at the participating sites will be asked to participate in the clinical investigation. According to national legislation, all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers, as to allow for sufficient reflection time.

If the subject decides to participate, the subject will receive treatment on Day 0 (Visit 1). At 1 month visit (Visit 2) an optional touch-up may be given as well as assessments performed. All subjects will be followed for 6 months with follow-up and assessments by visits in the clinic (Visit 2, Visit 3 and Visit 4).

Standardized facial photography will be taken prior to and after treatment during Visit 1 and 2 and during each follow-up visit at the clinic (Visit 3, Visit 4 and Visit 5). The photographs will be used for the evaluation of the primary efficacy endpoint of the blinded-evaluator using the Global Aesthetic Improvement Scale (GAIS) as well as the exploratory instrumental evaluation of the lip contour. GAIS will be used for blinded-evaluator assessment, treating Investigator assessment and patient satisfaction.

Numeric Pain Rating Scale (NRS) at each visit involving an injection (Visit 1 and Visit 2 - optional touch up) will be used to measure pain.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Investigational Medical Device

Other group

Description:

All eligible subjects desiring improvement and correction of their lip profile will receive injection of Decoria Essence in either one or both lips (upper, lower) and/or vermillion lines and/or perioral wrinkles/rhytids.

Treatment:

Device: Decoria Essence