Ellansé S for Nasolabial Folds

Recruiting at 6 trial locations

Overseen By Stuart R Boothman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AQTIS Medical B.V.

Must not be taking: Steroids, Chemotherapy, Immunosuppressants, others

Disqualifiers: Pregnancy, Diabetes, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of a new dermal filler, ELLANSÉ®-S, for treating nasolabial folds (the lines running from the sides of the nose to the corners of the mouth). Participants will receive ELLANSÉ®-S on one side of the face and a standard filler, Radiesse®, on the other, enabling researchers to compare results. The trial seeks individuals with noticeable nasolabial folds who have not recently undergone facial aesthetic procedures and are willing to avoid them during the study. As an unphased trial, this study offers participants the chance to contribute to the scientific understanding of new aesthetic treatments.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications like high-dose Vitamin E, aspirin, anti-inflammatories, and others that could increase bleeding risk should not be taken within two weeks before or one week after treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Ellansé S is well-tolerated for treating nasolabial folds (NLFs), the lines from the sides of the nose to the corners of the mouth. Research indicates that the treatment is generally safe, with common side effects including minor issues like bruising, swelling, tenderness, or small lumps at the injection site. These effects are typical with dermal fillers and usually resolve on their own.

Polycaprolactone, a key ingredient in Ellansé S, has been tested and found effective and safe in other studies, including those with Chinese patients who had moderate-to-severe NLFs, providing reassurance about its safety.

The control treatment, Radiesse, a well-known filler made from calcium hydroxylapatite, is also generally well-tolerated. Like Ellansé S, it may cause minor side effects such as swelling or tenderness.

Overall, both treatments in this trial have demonstrated a good safety record in past research, though individual experiences can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other treatments for nasolabial folds, ELLANSÉ®-S is unique because it combines polycaprolactone with carboxymethylcellulose gel. This combination is designed to provide both immediate volume and stimulate collagen production over time, potentially offering longer-lasting results than standard options like hyaluronic acid fillers. Researchers are excited about ELLANSÉ®-S as it not only fills wrinkles but also encourages the skin to rejuvenate itself, potentially leading to more natural and durable improvements.

What evidence suggests that Ellansé S might be an effective treatment for nasolabial folds?

Research has shown that Ellansé S, a type of dermal filler, effectively treats smile lines around the mouth, known as nasolabial folds (NLFs). In this trial, participants will receive either Ellansé S or Calcium Hydroxylapatite, another dermal filler. Previous studies demonstrated that when one side of the face was treated with Ellansé S, patients had fewer wrinkles at 6, 9, and 12 months compared to other treatments. By 24 months, all participants showed improvement in their wrinkles based on a standard improvement scale. Overall, Ellansé S proved more effective in reducing wrinkles and increasing patient satisfaction. These results suggest that Ellansé S is a promising choice for improving the appearance of NLFs. ^{1 2 6 7 8}

Who Is on the Research Team?

Jeremy B Green

Principal Investigator

Skin Research Institute LLC

Are You a Good Fit for This Trial?

This trial is for men and women with nasolabial folds who want to try a new dermal filler. Participants must be suitable for the treatment based on certain health criteria, but specifics are not provided here. People with darker skin types (at least 20% of participants) are encouraged to join.

Inclusion Criteria

I can attend all required follow-up visits and meet study needs.

Subject is willing to provide written informed consent for their participation in the study.

I have moderate to severe facial wrinkles.

Exclusion Criteria

Subject is predisposed to keloidosis or hypertrophic scarring.

Subject has participated in a clinical study involving an investigational device or drug in the 30 days prior to screening or plans to enroll in such a study during the current study.

I am not using effective birth control, am pregnant, breastfeeding, or plan to become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Subjects receive initial treatment with ELLANSÉ®-S or Radiesse® in one NLF and control in the contralateral NLF. Optional touch-up at 4 weeks.

4 weeks

1 initial visit, 1 optional touch-up visit

Follow-up

Participants are monitored for safety and effectiveness after treatment. Primary effectiveness assessed at 6 months.

24 months

Visits at 6 weeks, 3, 6, 9, 12, 18, and 24 months

Retreatment

Eligible subjects may receive retreatment at 12 or 18 months if criteria are met, with optional touch-up at 4 weeks post-retreatment.

12-18 months

Retreatment visit, 2-week safety visit, 3 and 6-month follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• ELLANSÉ®-S

Trial Overview

The study tests ELLANSÉ®-S, a calcium hydroxylapatite-based filler, against Radiesse®, another filler. It's done by treating one side of the face with ELLANSÉ®-S and the other side with Radiesse® in a double-blind setup where neither doctors nor patients know which product is used on which side.

How Is the Trial Designed?

Group I: Ellanse S Experimental Treatment 1 Intervention

Polycaprolactone and carboxymethylcellulose gel based dermal filler

Group II: Calcium Hydroxylapatite Active Control 1 Intervention

Calcium Hydroxylapatite and carboxymethylcellulose gel based dermal filler

Who Is Running the Clinical Trial?

AQTIS Medical B.V.

Lead Sponsor

Trials

2

Recruited

560+

Sinclair Pharmaceuticals Limited

Industry Sponsor

Trials

2

Recruited

360+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06984835

Safety and Effectiveness of ELLANSÉ®-S Dermal Filler in ...

The study will be a prospective, randomized, multi-center, split-face, controlled, double-blind clinical trial to evaluate the safety and effectiveness of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10171959/

Efficacy and Safety of Polycaprolactone in Treating ...

In a split-face trial, the polycaprolactone-based dermal filler showed better WSRS scores at 6 (2.0 vs. 2.3), 9 (2.2 vs. 2.9), and 12 (2.6 vs. 3.1) months than ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3615178/

Polycaprolactone for the Correction of Nasolabial Folds

GAIS assessments found 100% of subjects showing improvement in wrinkle severity at 24 months for PCL-2 and 90% of subjects showing improvement ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/jocd.70414?af=R

Comparing the Safety and Effectiveness of PCL and PLLA ...

PCL injections demonstrated superior effectiveness in reducing NLF wrinkle severity and achieving higher patient satisfaction compared to PLLA ...

5.

researchgate.net

researchgate.net/publication/359941911_A_randomized_participant-and_evaluator-blinded_matched-pair_prospective_study_to_compare_the_safety_and_efficacy_between_polycaprolactone-based_fillers_in_the_correction_of_nasolabial_folds

A randomized, participant‐and evaluator‐blinded, matched ...

Results: At month 12, both SF-01-and Ellansé-M®-treated groups showed statistically significant improvements in the WSRS, GAIS, and 3D scanner ...

6.

re-aesthetic.com

re-aesthetic.com/img/Aesthetic-Filler/1605-Ellanse-eSafety-report.pdf

ELLANSÉ® SAFETY

The present report is aimed at providing information to support the safety of ELLANSÉ® and defining its safety profile as a bioresorbable medical device ...

7.

sinclair.com

sinclair.com/media/dzunuwow/e-mdd-sscp-02-ellanse-mdd-sscp_digital-version-copy.pdf

Ellansé® Summary of Safety and Clinical Performance (SSCP

Pivotal data from equivalent devices indicates how safe and effective dermal fillers containing polyester micro particles perform in treating ...

8.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/jocd.13518

Polycaprolactone‐based dermal filler complications: A ...

Dermal fillers are generally considered as safe; immediate injection-related reactions such as bruising, swelling, tenderness and lumps are ...