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

NCT05235126 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-03-27

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Bohus Biotech AB

    lead INDUSTRY

Principal Investigators

  • Lucian Grema, MD · Florakliniken Stockholm Sweden

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2023-03-03
Completion
2023-03-03

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05235126 on ClinicalTrials.gov