What is ELLANSAE-S studying for nasolabial folds?

ELLANSAE-S is being studied to evaluate its safety and effectiveness in treating nasolabial folds. The trial compares ELLANSAE-S to another dermal filler, RadiesseAE, to see how well it improves wrinkle severity and patient satisfaction. This research is sponsored by AQTIS Medical B.V.

Who may be eligible for this nasolabial folds clinical trial?

Adults aged 22 years or older with moderate to severe nasolabial folds on both sides of the face may be eligible. Both males and females can participate. Key requirements include willingness to avoid other lower face treatments during the study and ability to attend all visits. Please review eligibility criteria for more details.

Is there any cost to participate in this nasolabial folds clinical trial?

Study-related care, including the dermal fillers and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 22Years +

All Genders

ID06984835

Safety and Effectiveness of ELLANSAE-S Dermal Filler Compared to RadiesseAE for Treating Nasolabial Folds in a Randomized, Double-Blind Split-Face Study

Led by AQTIS Medical B.V. · Updated on 2025-05-22

126

Participants Needed

Research Sites

78 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of ELLANSAE-S, a dermal filler, for treating nasolabial folds NLFs, which are the lines that appear around the nose and mouth. This is a prospective, randomized, multi-center, split-face, double-blind clinical trial comparing ELLANSAE-S to another dermal filler called RadiesseAE. The study will enroll 126 men and women aged 22 and older with moderate to severe NLFs. The trial aims to evaluate wrinkle improvement using the Wrinkle Severity Rating Scale WSRS and other aesthetic measures over time. Participants will receive ELLANSAE-S treatment on one side of the face and RadiesseAE on the other side. Initial treatment will be followed by an optional touch-up at 4 weeks, and some may receive retreatment at 12 or 18 months if the folds return to baseline or worsen by at least one point on the WSRS. Retreatment and touch-ups will be with ELLANSAE-S only. Safety visits and telephone follow-ups are scheduled at various intervals including 72 hours, 2 weeks, 4 weeks, and multiple months up to 24 months. The study will last about 30 months with all subjects followed for at least 24 months after initial treatment. Throughout the study, participants will undergo assessments including wrinkle severity scoring by masked reviewers, global aesthetic improvement ratings, pain evaluations, and questionnaires on satisfaction and appraisal of nasolabial folds. Safety is monitored closely with scheduled visits after each injection and touch-up. The primary effectiveness endpoint is the change in WSRS score at 6 months, with multiple secondary measures assessed up to 24 months. The study includes a diverse population with at least 20 having darker skin types Fitzpatrick IV-VI.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 22Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged at least 22 years
Bilateral moderate or severe (grade 3 or 4) nasolabial folds on the Wrinkle Severity Rating Scale
Willing to avoid other facial aesthetic procedures in the lower face through the study period
Able and willing to attend all scheduled follow-up visits
Agree to non-laser removal of facial hair if it obstructs assessment
Willing to avoid dental procedures for 3 weeks after treatment
Able to provide written informed consent
Best corrected visual acuity of 20/40 or better in each eye, with normal visual fields and eye movement

You will not qualify if you...

Female of childbearing potential not using effective birth control, pregnant, lactating, or planning pregnancy during the study
Participation in another clinical study with investigational device or drug within 30 days prior to screening or planned during this study
Employee or direct relative of employee at study site or sponsor
Previous surgery in the nasolabial folds
Prior facial threads or autologous fat injections in the face
Serious or progressive disease posing undue risk
Acute or chronic inflammatory or infectious conditions affecting results
Disorders impacting wound healing like connective tissue or immunosuppressive disorders
History of precancerous lesions or skin malignancies
Active skin disease within past 6 months
Scars, infection, rosacea, herpes, acne, or other pathologies in the nasolabial folds affecting assessment
Unwillingness to remove facial hair covering nasolabial folds
History of streptococcal disease or active infection
Recent COVID-19 vaccination or viral illness
Predisposition to keloid or hypertrophic scarring
Known pigmentation disorders in the nasolabial folds
Allergy to study materials or anesthetics
Bleeding disorders
Recent use of medications increasing bleeding risk
Use of medications interfering with study objectives
Recent or planned use of facial injections outside study protocol
Recent or planned use of permanent, semi-permanent, or long-lasting fillers
Recent dermal resurfacing or skin tightening procedures
Recent use of prescription facial wrinkle treatments, topical steroids, or irritating topical agents
Recent systemic retinoids, steroids, chemotherapy, or immunosuppressants
Ongoing or planned rapid weight change of 5% body weight during the study

Research Team

Paul Morris

Stuart R Boothman

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