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A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds

NCT ID: NCT07292779

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nasolabial Folds, Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DMFI150

Single injection of DMFI150

Group Type EXPERIMENTAL

DMFI150

Intervention Type DEVICE

Injection of DMFI150 for nasolabial folds.

Interventions

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DMFI150

Injection of DMFI150 for nasolabial folds.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ocean Clinic

Marbella, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Vanessa

Role: primary

Other Identifiers

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LF15_NLF_EU

Identifier Type: -

Identifier Source: org_study_id