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NCT06984835 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of ELLANSÉ®-S Dermal Filler in the Treatment of Nasolabial Folds
A NA study of Nasolabial Folds, sponsored by AQTIS Medical B.V..
- Recruiting
- Registry status
- NA
- Development phase
- 126
- Enrollment target
- 7
- Study locations
NCT06984835 is a NA study of Nasolabial Folds that is actively recruiting participants, run by AQTIS Medical B.V.. The registered enrollment target is 126 participants, above the 35-participant average among 4 other Nasolabial Folds trials with a reported enrollment target (260% higher). The trial reports 7 study locations across 7 states.
The verdict
NCT06984835, a NA study of Nasolabial Folds, is actively recruiting participants, sponsored by AQTIS Medical B.V..
- RECRUITING
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
- 7
- Study locations
Study Summary
The study will be a prospective, randomized, multi-center, split-face, controlled, double-blind clinical trial to evaluate the safety and effectiveness of ELLANSÉ®-S for the treatment of NLFs. Subjects will be randomized to receive treatment (ELLANSÉ®-S) in one NLF and control (Radiesse®) in the contralateral NLF. A total of 126 subjects will be treated. The control and test articles will be supplied in sterile ready-to-use, pre-filled syringes. Initial treatment and any 4-week touch-up will be done consistent with initial randomization. Any retreatment(s) in either NLF will be with ELLANSÉ®-S. Subjects who meet Inclusion/Exclusion criteria will receive an initial treatment, an optional touch up at the 4-week visit, and may be eligible to receive retreatment at either 12 or 18 months after treatment (determined by when the fold has returned to baseline score, or the fold has lost at least 1 point on the Wrinkle Severity Rating Scale (WSRS) from optimal improvement). Retreatment to one side is allowed if only one side qualifies, but the other side may not be retreated at a later visit. If retreatment occurs, the subject may also be eligible to receive an optional touch up at the 4-week follow up visit. If a touch up occurs after the initial or retreatment injection, the subject will return for an additional safety visit 2 weeks after each injection. A week 4 safety visit will occur after retreatment touch-up. Primary effectiveness will be assessed at 6 months. All subjects will be followed for a minimum of 24 months after the initial treatment phase. After each injection, subjects will be contacted by telephone call/email after 72 hours and will return for a safety visit 2 weeks after treatment. At the week 4 visit, subjects will be assessed for a touch up. If a touch up is indicated as determined by the investigator, the investigator will use the same material as that used for initial treatment for the respective side. In addition, subjects will be seen at 6 weeks
Conditions Studied
Interventions
- DEVICE Ellanse S
- DEVICE Calcium Hydroxylapatite-based filler
Study Locations (7)
Arizona
- Investigate MD - Scottsdale
California
- Clinical Testing of Beverly Hills - Encino
Connecticut
- DMR Research, PLLC - Westport
Florida
- Skin Research Institute LLC - Miami
Maryland
- Callender Center for Clinical Research - Glenn Dale
Massachusetts
- Skincare Physicians - Chestnut Hill
Michigan
- Advanced Dermatology of Michigan - Warren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2025-03-31 |
| Est. Completion | 2027-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06984835
The ClinicalTrials.gov registry entry for NCT06984835 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 35-participant average among 4 other Nasolabial Folds trials with a reported enrollment target (260% higher). The listed sponsor is AQTIS Medical B.V., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nasolabial Folds appearing as the primary indexed condition, and to 2 interventions - of which Ellanse S is the first listed.
NCT06984835 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Arizona, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06984835 about?
NCT06984835 is a clinical study titled "Safety and Effectiveness of ELLANSÉ®-S Dermal Filler in the Treatment of Nasolabial Folds". The study will be a prospective, randomized, multi-center, split-face, controlled, double-blind clinical trial to evaluate the safety and effectiveness of ELLANSÉ®-S for the treatment of NLFs. Subjects will be randomized to receive treatment (ELLANSÉ®-S) in one NLF and control (Radiesse®) in the con...
What is the current status of trial NCT06984835?
This trial is currently recruiting. It is a NA study. The enrollment target is 126 participants. The study started on 2025-03-31. Estimated completion is 2027-12.
What conditions does trial NCT06984835 study?
This clinical trial studies the following conditions: Nasolabial Folds.
What interventions are being tested in trial NCT06984835?
The interventions under investigation include: Ellanse S (DEVICE), Calcium Hydroxylapatite-based filler (DEVICE).
Who is sponsoring clinical trial NCT06984835?
This trial is sponsored by AQTIS Medical B.V., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06984835 being conducted?
This trial has 7 study locations across Arizona, California, Connecticut, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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