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

Correction of Nasolabial Folds Clinical Trial

— Decorate01  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235126
• Other study ID #: Decorate01
• Status: Completed
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: July 2023
• Source: Bohus Biotech AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Correction of Nasolabial Folds

Intervention

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).

Locations

Country	Name	City	State
Sweden	MyBeauty Clinic	Halmstad
Sweden	Florakliniken	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Bohus Biotech AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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