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

NCT05235126 | Completed

• 1 other identifier: Decorate01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Correction of Nasolabial Folds

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Subject satisfaction with treatment

  12 months

• PI satisfaction with treatment

  6 months

Study Arms (1)

Treatment arm

OTHER

All subjects receive treatment at V1 and option to receive touch-up at V2.

Device: Decoria intense

Interventions

Decoria intense DEVICE

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).

Treatment arm

Eligibility Criteria

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

You may qualify if:

• Male or Female, ≥18 years of age, of all weight spans, desiring correction of their nasolabial folds.
• 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).
• 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.

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.
• Any acute or chronic skin disease or inflammation (such as pimples, rashes or hives) within or close to the area selected for correction.
• Any bleeding disorder or treatment with thrombolytics or anticoagulants.
• Any treatment with interferon and ribavirin.
• Any vaccine taken within 2 weeks prior to the treatment visit.
• 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).
• 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.
• Any other condition or treatment making the subject unsuitable for participation in the clinical investigation, as judged by the Principal Investigator.
• Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.

Sponsors & Collaborators

• Bohus Biotech AB: lead

Study Sites (2)

MyBeauty Clinic

Halmstad, 302 32, Sweden

Location

Florakliniken

Stockholm, Sweden

Location

Study Officials

• Lucian Grema, MD

  Florakliniken Stockholm Sweden

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All subjects will receive open treatment with Decoria intense for correction of nasolabial folds at Visit 1 with optional touch-up at Visit 2.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 11, 2022
• Study Start: February 17, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: March 27, 2026

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)