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Recruiting NCT07292779

A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds

No phase Interventional Nasolabial Folds, Wrinkles

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: DMFI150.
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, Clinical Investigation to Evaluate the Performance and Safety of DMFI150 for the Treatment of Nasolabial Folds

Overview

This is a prospective clinical investigation designed to evaluate the performance and safety of DMFI150 for the treatment of nasolabial folds. 30 adult participants will receive a single treatment with the investigational device. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.

Interventions

  • Device DMFI150
    Injection of DMFI150 for nasolabial folds.

Primary outcome measures

  • Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator Investigator (EI) [Time frame: Baseline to Month 12]
Secondary outcome measures (3)
  • Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluator Investigator (EI) and the Treating Investigator (TI) [Time frame: Baseline to Month 1,3,6,9,12]
  • Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and by the Subject [Time frame: Baseline to Month 1,3,6,9,12]
  • 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 WSRS (1 = absent, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme) for both nasolabial folds.
  • Able and willing to provide written informed consent.
  • Willing to refrain from facial cosmetic procedures during the study.

Exclusion criteria

  • Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or 2 weeks after treatment.
  • History or current bleeding disorders.
  • Participation in another clinical trial within 1 month before screening.
  • Pregnant or breastfeeding women, or planning pregnancy.
  • Women of childbearing potential not using effective 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
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Ocean Clinic — Marbella

Identifiers

NCT: NCT07292779 · LF15_NLF_EU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗