Safety and Effectiveness of ELLANSÉ®-S Dermal Filler in the Treatment of Nasolabial Folds

Launched by AQTIS MEDICAL B.V. · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a product called ELLANSÉ®-S, which is a type of dermal filler used to treat nasolabial folds—those lines that run from the sides of your nose to the corners of your mouth. In this study, 126 participants will have one side of their face treated with ELLANSÉ®-S and the other side treated with a different filler called Radiesse®. Participants will be monitored over a period of 24 months to see how well the treatments work and if there are any side effects.

To be eligible for this trial, participants need to be at least 22 years old and have moderate to severe nasolabial folds. They should also be willing to avoid other facial treatments during the study period. Participants can expect to receive an initial treatment, possibly a touch-up four weeks later, and may have the option for additional treatments after 12 or 18 months if needed. Throughout the trial, there will be regular follow-up visits to check on their safety and the effectiveness of the treatments. This study aims to provide valuable information about how ELLANSÉ®-S can improve the appearance of nasolabial folds and how safe it is for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Only subjects meeting all of the following inclusion criteria will be considered for study enrollment:
• • 1. Subject is male or female aged at least 22 years.
• • 2. Subject has bilateral moderate or severe (symmetric grade 3 or 4) NLFs on the WSRS as scored by the treating investigator.
• • 3. Subject is willing to abstain from other facial aesthetic procedures in the lower face including the NLFs through the study period (up to the final follow-up visit, depending on retreatment) which could interfere with treatment outcomes (e.g. facial fillers, skin laser and radiofrequency therapy such as Thermage, chemical re-surfacing, dermabrasion, Botox injections, aesthetic facial surgery, other facial treatments in the NLFs).
• • 4. Subject understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
• • 5. Subject with facial hair which may obstruct the assessment of the treatment area, must be agreeable with non-laser removal of facial hair prior to assessment visits.
• • 6. Subject agrees to avoid dental procedures (surgery, implants, dental work) for 3 weeks after any treatment.
• • 7. Subject is willing to provide written informed consent for their participation in the study.
• • 8. Subject has best corrected visual acuity of 20/40 or better (in each eye), and have normal confrontational visual fields, and normal extraocular motility.
• Exclusion Criteria:
• Subjects having any of the following criteria, either at screening or at baseline, will not be included in the study:
• • 1. Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods in use at least 30 days prior to injection or barrier methods such as condom and spermicide in use at least 14 days prior to injection) or is pregnant, lactating, or plans to become pregnant during the study.
• • 2. Subject has participated in a clinical study in which an investigational device or drug was received in the 30 days prior to screening or plans to enroll in such a study during the course of the current study.
• • 3. Subject is an employee or direct relative of an employee of the investigational site or study sponsor.
• • 4. Subject has received surgery in the NLFs.
• • 5. Subject has received facial threads or autologous fat injections in the face.
• • 6. Subject has a serious or progressive disease, which, in the investigator's judgment, puts the subject at undue risk (e.g., uncontrolled diabetes, autoimmune disease, cardiac pathologies).
• • 7. Subject has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
• • 8. Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
• • 9. Subject has a history of precancerous lesions/skin malignancies.
• • 10. Subject has had an active skin disease within the past 6 months.
• • 11. Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology in the NLFs that in the Investigator's opinion will affect evaluation or treatment.
• • 12. Subject has facial hair covering the nasolabial folds that they are unwilling to remove for study assessments.
• • 13. Subject has a past history of systemic streptococcal disease or an active streptococcus infection.
• • 14. Subject has had a COVID-19 vaccine within 2 weeks of scheduled injections or plans to receive one 3 weeks after any study injection.
• • 15. Subject was ill with a virus (SARS, COVID, flu) within 2 weeks of scheduled injection.
• • 16. Subject is predisposed to keloidosis or hypertrophic scarring.
• • 17. Subject has a known history of hyper- or hypo-pigmentation in the NLFs.
• • 18. Subject with known allergy to poly (ε-caprolactone), phosphate buffered saline, glycerine, calcium hydroxylapatite (CaHA), or sodium carboxymethylcellulose.
• • 19. Subject has a known history of multiple allergies, allergic/anaphylactic reactions including hypersensitivity to lidocaine or anesthetics of the amide type.
• • 20. Subject has a known bleeding disorder.
• • 21. Subject has received within the past 2 weeks or plans to receive up to 1 week after treatment high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelets, thrombolytics or any other medication that could increase the risk of bleeding.
• • 22. Subject has received any medication which, in the judgement of the investigator, may interfere with the study objectives.
• • 23. Subject has received within the past 12 months or plans to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., hyaluronic acid) or neurotoxin on the face below cheekbone (forehead is acceptable).
• • 24. Subject has received at any time or plans to receive during the study a permanent filler (e.g., PMMA, silicone) on the face below the cheekbone.
• • 25. Subject has received within the past 24 months or plans to receive during the study a semi-permanent or long last filler (e.g. polylactic acid or calcium hydroxylapatite CaHA) on the face.
• • 26. Subject has received within the past 6 months or plans to receive during the study dermal resurfacing procedures or non-invasive skin tightening or energy based or mechanical or chemical aesthetic procedure on the face.
• • 27. Subject has received in the past 4 weeks or plans to receive during the study prescription facial wrinkle therapies (tretinoin), topical steroids,
• • 28. Subject has received within the past 2 weeks skin irritating topical preparations, or self-tanning agents on the face.
• • 29. Subject has received within the past 6 months systemic retinoids.
• • 30. Subject has received within the past 3 months systemic steroids or chemotherapy or immunosuppressive agents.
• • 31. Subject has a known history of ongoing rapid weight loss/gain or plans to begin a weight loss program during the study (5% of body weight).