A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DMFI300, Ellansé-M.
- Who it may be relevant to
- Registry conditions: Nasolabial Folds, Wrinkles. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Participant- and Evaluator-blinded, Randomized, Controlled, Split-face Clinical Investigation to Evaluate the Performance and Safety of Polycaprolactone 300 (DMFI300) for the Treatment of Nasolabial Folds
Overview
This is a prospective, randomized, controlled clinical investigation designed to evaluate the performance and safety of DMFI300 for the treatment of nasolabial folds. 30 adult participants will receive treatment with the investigational device and the comparator device using a split-face design. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
Interventions
- Device DMFI300
Injection of DMFI300 for nasolabial folds. - Device Ellansé-M
Injection of Ellansé-M for nasolabial folds.
Primary outcome measures
- Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluating Investigator (EI) [Time frame: Baseline to Month 12]
Secondary outcome measures (5)
- Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluating Investigator (EI) and the Treating Investigator (TI) [Time frame: Baseline to Month 1,3,6,9]
- Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and the Subject [Time frame: Month 1,3,6,9,12]
- Subject Satisfaction With Treatment Using a Five-Point Likert Scale [Time frame: Month 12]
- Proportion of Subjects Receiving Touch-up Treatment [Time frame: Month 1]
- Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs) [Time frame: Baseline through Month 12]
Eligibility criteria
Inclusion criteria
- Men and women aged 18-70 years.
- Score of 3 to 4 on the Wrinkle Severity Rating Scale (WSRS) for both nasolabial folds.
- Willing and able to provide written informed consent.
- Willing to comply with study procedures and follow-up visits.
- Willing to refrain from other facial cosmetic procedures affecting the nasolabial folds during the study.
Exclusion criteria
- Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or planned use within 2 weeks after treatment.
- History or presence of bleeding disorders.
- Participation in another clinical investigation within 1 month prior to screening.
- Pregnant or breastfeeding women, or women planning pregnancy during the study.
- Women of childbearing potential not using an effective method of contraception.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Ocean Clinic — Marbella
Identifiers
NCT: NCT07467239 · LF30_NLF_EU