Clinical Investigation on Lips Treated With HA-filler

NCT07188818 | Active Not Recruiting

• 1 other identifier: CIV-24-04-046794
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Aesthetic Correction of the Lips

Keywords

lips profile; lip augmentation; correction of perioral rhytids; lip volume; lip contour

Outcome Measures

Primary Outcomes (2)

• Primary efficacy endpoint to measure the change/improvement in score using the Global Aesthetic Improvement Scale (GAIS)

  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.

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

• Primary safety endpoint by evaluating Adverse Events

  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.

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

Secondary Outcomes (6)

• Secondary endpoint evaluating pain by Numeric Pain Rating Scale (NRS)

  At baseline (Visit 1, Day 0) and optional touch-up (Visit 2, Day 30)

• Secondary endpoint evaluated improvement by GAIS score

  At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180)

• Secondary endpoint by evaluating improvement by GAIS

  At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180)

• Secondary endpoint evaluating treatment related Adverse Events

  30 days after injection of initial treatment (Day 0-30) and optional touch-up (Day 30-60)

• Secondary endpoint by instrumental evaluation of lips by image analysis.

  From pre-intervention baseline, to post-treatment at Day 1, 30, 90 and 180 respectively

Study Arms (1)

Investigational Medical Device

OTHER

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.

Device: Decoria Essence

Interventions

Decoria Essence DEVICE

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).

Investigational Medical Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects receiving interferon and ribavirin treatment.
• Features that may interfere with the visual assessment such as recent cosmetic treatment, scarring, abscess, piercing or tattoo below the nose.
• Participation in a clinical investigation that may affect the safety or performance of this investigation, as judged by the Principal Investigator, or authorized designee.
• Employees of the study site or the sponsor directly involved with the conduct of the investigation

Sponsors & Collaborators

• Bohus Biotech AB: lead
• Key2Compliance: collaborator

Study Sites (6)

Advanced Clinic

Gothenburg, 41122, Sweden

Location

Svenska Hudkliniker Karlstad

Karlstad, 65225, Sweden

Location

Hansa Estetik

Malmo, 21138, Sweden

Location

Svenska Hudkliniker

Stockholm, 114 46, Sweden

Location

Dr Filip

Stockholm, 11456, Sweden

Location

Peri Estetik

Västerås, 72212, Sweden

Location

Study Officials

• Lucian Grema, M.D.

  Diagnostiskt Centrum Hud, Konsult LBG vard AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: September 23, 2025
• Study Start: December 9, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-01

Locations

SE (6)