Enrolling by invitation

DAG-ESSDecoria® Essence for Lip Profile Enhancement

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What is being tested

Decoria Essence

Device
Who is being recruted

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorBohus Biotech AB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 9, 2024

Actual date on which the first participant was enrolled.

This clinical study aims to verify how safe and effective Decoria® Essence is for enhancing the appearance of lips. People interested in improving their lip profile are invited to participate. The study seeks to ensure that this treatment performs well and causes no significant issues. This is important because it might offer a reliable option for those looking to enhance their lips, addressing a common cosmetic concern with validated safety and performance. Participants will undergo an initial treatment, and an optional touch-up may be given after one month if needed. The study involves clinic visits over six months to monitor progress and outcomes. During these visits, standardized photos will be taken to assess changes using the Global Aesthetic Improvement Scale (GAIS), which helps evaluate the effectiveness of the treatment. The study also measures any pain experienced during the injections using a Numeric Pain Rating Scale. This approach ensures that both the safety and the satisfaction of the participants are thoroughly evaluated.

Official TitleA Post-market-clinical Follow-up Investigation of Safety and Performance of Decoria® Essence
NCT07188818
Principal SponsorBohus Biotech AB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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.
12 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Advanced Clinic

Gothenburg, SwedenOpen Advanced Clinic in Google Maps
Suspended

Svenska Hudkliniker Karlstad

Karlstad, Sweden
Suspended

Hansa Estetik

Malmo, Sweden
Suspended

Svenska Hudkliniker

Stockholm, Sweden
Enrolling by invitation6 Study Centers