AI-Powered Research

Signed informed consent form
- Study participants who are 18 years of age or older and are able to give their consent.
- Study participants who wish to undergo volume augmentation therapy in the nasolabial fold area.
- Understanding of the study procedures and consent to participate in the study procedures.
- Volume deficiency of the nasolabial fold of moderate to very severe intensity (grades 2-4) on the Merz nasolabial folds scale. Established on the day of the baseline visit and prior to the start of the study up to a maximum of 6 months earlier.
- Symmetrical assessment of both nasolabial folds by the investigator (equal intensity of both nasolabial folds on the Merz nasolabial folds scale and no obvious asymmetries).
- The study participant is willing to refrain from interfering facial treatments during the study period, such as filler injections, botulinum toxin treatments, facial ablative or fractional laser treatments, microdermabrasion, chemical peels, plastic aesthetic surgical interventions, and observes contraindications, precautions and warnings.

Exclusion Criteria

- Previous treatment in the past using calcium hydroxyapatite, silicone, polymethyl methacrylate (PMMA), fat injections, poly-L lactic acid in the area of the nasolabial fold.
- Plastic-aesthetic facial surgery in the past, which in the opinion of the investigator has a effect on the appearance of the nasolabial fold
- Treatment with hyaluronic acid containing fillers in the area of the nasolabial fold in the last 12 months as well as planned treatments within the study period
- Treatment within the last 6 months (as well as planned treatments within the study period) with facial dermal therapies (e.g., epilation, ultraviolet irradiation, radiofrequency ablation or non-ablative facial treatment, laser treatment, microdermabrasion, mechanical or chemical peels, non-invasive skin tightening (e.g., Ultherapy, Thermage), or surgical procedures)
- Treatment with botulinum toxin within the last 4 months (as well as planned botulinum toxin therapy within the study period).
- Systemic relevant immunosuppressive treatment (e.g. prednisolone, azahioprine, mycophenolate mofetil, rituximab) within the last 12 months (as well as planned therapy within the study period)
- Cosmetic/topical treatment with fruit/glycolic acid containing topicals in the area of the treated area within the last 30 days as well as 30 days after injection
- Known blood coagulation disorder or use of anticoagulants within the last 10 days before and planned use until 3 days after treatment (e.g., ASS, phenprocoumon, etc.)
- Known and/or documented allergy to any of the ingredients of Juläine®.
- Acute inflammation or infection in the treatment area or acute or chronic skin disease that, in the opinion of the investigator, may lead to an increased risk
- Facial nerve paresis
- Known history of hypertrophic scarring or keloid formation
- Current malignant disease (<5 years since initial diagnosis, except for basal cell carcinoma and squamous cell carcinoma of the skin outside of the treatment area)
- Parallel participation in another clinical trial up to 30 days prior to inclusion and up to 30 days after completion of the present study
- Pregnancy, lactation
- Known severe autoimmune diseases (e.g., scleroderma, lupus erythematosus, rheumatoid arthritis)

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Evaluation of the usability and applicability by the investigators - at all visits where Juläine® is used.<br>- Tolerability (evaluation by investigators and study participants) - at all visits.<br>- Efficacy at the end of the study 26 weeks after the last use of the study product.

Secondary Outcome Measures

Name	Time	Method
Efficacy at the remaining study time points (for up to two applications 2-4 weeks after the previous application and at weeks 4 and 12 after the last application of the study product).