A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds (NLF) (Decorate01)

A Post-market, Prospective, Observational (Non-interventional), Partly Confirmatory, Multi-centre Clinical Investigation to Confirm the Clinical Safety and Performance Profile of Decoria® Intense Hyaluronic Acid Dermal Filler for the Correction of Nasolabial Folds.

Decoria intense is a class III medical device and is CE-marked and has been on the market since 2014. Decoria intense is a hyaluronic acid filler that will be used according to intended use for correction of nasolabial folds.

According to the new MDR in EU this clinical investigation will confirm efficacy and safety of Decoria intense.

The plan is to recruit 80 subjects to receive 64 evaluable subjects during 6 months recruitment.

The clinical investigation contains 5 visits and the total time per subject is 12 months. All subjects will receive treatment at Visit 1 with the option to receive a touch-up treatment at Visit 2. Evaluation of the nasolabial folds will be performed by PI using the Wrinkle Severity Rating Scale (WSRS)

Study Overview

• Status: Completed
• Conditions: Correction of Nasolabial Folds
• Intervention / Treatment: Device: Decoria intense

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Johansson; Phone Number: +46 526 721 160; Email: quality.manager@bohusbiotech.com
• Study Contact Backup: Name: Kjell Willhed; Phone Number: + 46 709 670037; Email: kjell.willhed@key2compliance.com

Study Locations

• Sweden
  • Halmstad, Sweden, 302 32
    • MyBeauty Clinic
  • Stockholm, Sweden
    • Florakliniken
    • Contact: Lucian Grema, MD; Phone Number: +46 727 336055; Email: grema72@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or Female, ≥18 years of age, of all weight spans, desiring correction of their nasolabial folds.
2. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF).
3. The subject has nasolabial folds considered at least moderate (grade 3) according to the Wrinkle Severity Rating Scale (WSRS), as assessed by the Principal Investigator.

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. Any acute or chronic skin disease or inflammation (such as pimples, rashes or hives) within or close to the area selected for correction.
4. Any bleeding disorder or treatment with thrombolytics or anticoagulants.
5. Any treatment with interferon and ribavirin.
6. Any vaccine taken within 2 weeks prior to the treatment visit.
7. Any other intradermal injection, such as fillers or toxins, received in the same injection area within 6 months of the Screening and Treatment visit (Visit 1).
8. Participation in a clinical investigation study that may affect the safety or performance of this investigation, within one year of enrolment, or planned participation in such investigation at any time during this clinical investigation, as judged by the Principal Investigator.
9. Any other condition or treatment making the subject unsuitable for participation in the clinical investigation, as judged by the Principal Investigator.
10. Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment arm; All subjects receive treatment at V1 and option to receive touch-up at V2.	Device: Decoria intense; All subjects will receive treatment at Visit 1 with the option to receive a touch-up treatment at Visit 2. Evaluation of the nasolabial folds will be performed by PI using the Wrinkle Severity Rating Scale (WSRS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the WSRS score	The primary efficacy endpoint is to measure the change in the WSRS score from pre-treatment baseline, at 3 months post OCR, as assessed by the Principal Investigator. The WSRS range from 1 (absent - no visible fold) to 5 (extreme - extremely deep and long folds). A subject improving 1 score or more is classified as "responder". A stable subject or a subject worsening is classified as "non-responder".	3 months after pre-treatment (baseline)
The rate of adverse events	The primary safety endpoint is to assess the safety of Decoria® intense, evaluated by the rate of adverse events throughout the study period.	12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction with treatment	The subject will assess the satisfaction with the treatment at all visits using the Global Aesthetic Improvement Scale (GAIS) 1 - 5. 1. Exceptional improvement, 2. Very improved patient, 3. Improved patient, 4. Unaltered patient, 5. Worsened patient.	12 months
PI satisfaction with treatment	The PI will assess the satisfaction with the treatment at all visits except for visit 5 (telephone visit) using the Global Aesthetic Improvement Scale (GAIS) 1 - 5. 1. Exceptional improvement, 2. Very improved patient, 3. Improved patient, 4. Unaltered patient, 5. Worsened patient.	6 months

Collaborators and Investigators

• Sponsor: Bohus Biotech AB
• Investigators: Principal Investigator: Lucian Grema, MD, Florakliniken Stockholm Sweden

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Decorate01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No