A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Intense Strong

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-06

Study Completion Date

2025-09-30

Brief Summary

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A post-market Follow up clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile.

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Detailed Description

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This will be a post-market, open label, prospective, interventional, confirmatory, evaluator-blinded,multi - centre, clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile.

Subjects desiring correction of their jawline profile at the participating sites will be asked to participate in the clinical investigation. According to national legislation, all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers, as to allow for sufficient reflection time.

If the subject decides to participate, the subject will receive treatment on Day 0 (Visit 1). At 1 month visit (Visit 2) an optional touch-up may be given as well as assessments performed. All subjects will be followed for 9 months with follow-up and assessments by visits (Visit 2, Visit 3 and Visit 5) and phone call (Visit 4).

Standardized facial photography will be taken prior to and after treatment during Visit 1 and 2 and during each follow-up visit at the clinic (Visit 3 and Visit 5), for evaluation according to GAIS and the exploratory instrumental evaluation of jawline contour. GAIS will be used for blinded-evaluator assessment, treating Investigator assessment and patient satisfaction.

Numeric Pain Rating Scale (NRS) at each visit involving an injection (Visit 1 and Visit 2 - optional touch up) will be used to measure pain.

Conditions

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Jawline Contour Deficit

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational Medical Device

All eligable subjects desiring correction of their jawline profile will receive intradermal injection of Decoria Intense Strong on either one or both sides of the face (including or not including the chin).

Group Type OTHER

Decoria Intense Strong

Intervention Type DEVICE

Decoria® Intense Strong is a HA-based, BDDE-crosslinked dermal filler. Decoria® Intense Strong dermal fillers are injected into dermal tissue to improve and define contouring of jawline profile, supporting overlying tissue to shape facial contours to desired level of correction.

Appropriate injection volume for the jawline will be determined by the Treating investigator according to IFU

Interventions

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Decoria Intense Strong

Decoria® Intense Strong is a HA-based, BDDE-crosslinked dermal filler. Decoria® Intense Strong dermal fillers are injected into dermal tissue to improve and define contouring of jawline profile, supporting overlying tissue to shape facial contours to desired level of correction.

Appropriate injection volume for the jawline will be determined by the Treating investigator according to IFU

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults ≥18 years, males and females.
2. Able and willing to give written informed consent for participation in the investigation.
3. Treating investigator considers the subject's jaw (including or not including chin) amenable to an improvement of at least 1 grade on GAIS. At least one side with either potential to enhance contouring or moderate to severe loss of jawline definition. The grades do not have to be the same on both sides.
4. Ability to follow study instructions and likely to complete all required visits.

Exclusion Criteria

1. Pregnant or lactating females.
2. Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anesthetic products.
3. 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.
4. 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.
5. Has an ongoing episode/relapse, recently diagnosed or newly started medication of an autoimmune disease, as judged by the investigator.
6. Has any chronic or acute skin disease or inflammation (such as pimples, rashes or hives) within or close to the treatment area.
7. Has any treatments (thrombolytics, anticoagulants etc) or disease related to the coagulation system.
8. Subjects that have taken any type of vaccine within two weeks prior injection with the IMD.
9. Patients receiving interferon and ribavirin treatment.
10. Features that may interfere with the visual assessment such as recent cosmetic treatment, scarring, abscess, piercing or tattoo.
11. Participation in a clinical investigation that may affect the safety or performance of this investigation, as judged by the Principal Investigator, or authorized designee.
12. Employees of the study site or the sponsor directly involved with the conduct of the investigation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucian Grema, M.D

Role: PRINCIPAL_INVESTIGATOR

Florakliniken, Stockholm, Sweden

Locations

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