DMFI150 to reduce nasolabial fold wrinkles

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label interventional study will enroll 30 adults with moderate-to-severe nasolabial folds (WSRS 3–4) to receive a single treatment with the investigational device DMFI150. Investigators will use validated aesthetic scales to rate wrinkle severity at baseline and at scheduled follow-up visits and will record adverse events to characterize safety. Eligible participants must be 18–70 years old, agree to avoid other facial cosmetic procedures during the study, and meet medication and reproductive criteria. The study is conducted at a single center in Marbella, Spain.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ocean Clinic
  Marbella, Spain Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DMFI300 versus Ellansé‑M for nasolabial fold wrinkles

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• Bridging Technique with AILEENE Vol. 2 for Softening Nasolabial Folds

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• RADIESSE Injectable Implant for correcting moderate to severe nasolabial folds

  This study tests RADIESSE Injectable Implant to see if it is safe and effective for adults in China with noticeable nasolabial folds.

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• Safety and effectiveness of NOA LIFT vs VOLIFT for correcting nasolabial folds in adults

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• CelluJuve for moderate to severe Nasolabial Fold Wrinkles

  This study tests CelluJuve® to see if it can improve moderate to severe nasolabial folds in adults.

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• Hyaluronic acid fillers for lips, cheeks, nasolabial folds, perioral lines, and under-eye hollows in everyday practice

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.