Purpose of This Study is the Demonstration of Safety and Efficacy of the Dermal Fillers DXP01 Temporary Improvement of Moderate to Severe Nasolabial Folds

NCT06885775 | Not Yet Recruiting Phase 2

• 1 other identifier: DXP01_NFE-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of this study is the demonstration of safety and efficacy of the dermal fillers DXP01 Face for restoration of moderate to severe nasolabial folds

Conditions

Dermal Fillers; Nasolabial Folds, Wrinkles

Keywords

NASOLABIAL FOLDS; DXP01

Outcome Measures

Primary Outcomes (1)

• The difference in the WSRS (Wrinkle Severity Rating Scale) between the treatment groups at 24 weeks after device application, as evaluated by an independent assessor.

  The primary objective of the study is to demonstrate the non-inferiority of DXP01 compared to Juvéderm® ULTRA 3 by assessing the mean WSRS (Wrinkle Severity Rating Scale) score at 24 weeks, as evaluated by an independent assessor, in adults with moderate to severe nasolabial folds after administration of DXP01 and Juvéderm® ULTRA 3.\[The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and week 24. A positive value indicated "effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.\]

  Baseline and week 24

Secondary Outcomes (4)

• • Efficacy of DXP01 as assessed by difference in the mean Wrinkle Severity Rating Scale (WSRS) score

  • At 2, 8, 16, 36 and 48 weeks after device application

• • Efficacy of DXP01 as assessed by difference in the mean Global Aesthetic Improvement Scale

  • At 2, 8, 16, 36 and 48 weeks after device application

• • Product safety 2 weeks~48 weeks

  • 2 weeks of treatment and during 48 weeks after treatment.

• • The mean value differences in the Pain Score Using Visual Analog Pain Scale(VAS) between

  • After 15, 30, 45, 60 minutes(Immediate post-injection)

Study Arms (2)

Participant Group/Arm

EXPERIMENTAL

Device: DXP01 DXP01 is an opaque whit, containing polycaprolactone, carboxymethylcellulose, purified water in a injection solution, pre-filled in a syringe. Polycaprolactone is a 100% bioresorbable and highly biocompatible medical polymer that is metabolized and excreted through normal pathways as carbon dioxide (CO2) and water (H2O). Due to these properties, PCL fillers have received European CE certification and U.S. FDA approval as medical devices for dermal and subcutaneous insertion for wrinkle improvement since 2009.

Device: DXP01

Treatment

ACTIVE COMPARATOR

Device: Juvederm ULTRA 3 Description: Juvéderm® ULTRA 3 is a sterile pyrogen-free physiological solution of cross-linked hyaluronic (HA) acid which is not of animal origin. The gel is presented in a graduated, pre-filled, disposable syringe. Juvéderm® ULTRA 3 is an injectable implant used for filling mid and/ or deep depressions of the skin via mid and/or deep dermis injection, as well as for lip definition and enhancement.

Device: Juvederm ULTRA 3

Interventions

DXP01 DEVICE

PCL Dermal Filler

Participant Group/Arm

Juvederm ULTRA 3 DEVICE

HA Dermal filler

Treatment

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 19 to 70 years.
• Subjects with nasolabial folds (NLF) on both sides scored at 3 or 4 on the WSRS (Wrinkle Severity Rating Scale) as evaluated by the investigator at screening (both sides do not need to have the same score but must fall within the 3-4 range).
• Subjects with visually symmetrical nasolabial folds (NLF) on both sides.
• Subjects who can comply with the clinical trial procedures and will not undergo any facial cosmetic procedures/surgeries contraindicated for combination therapy during the clinical trial.
• Males and females of childbearing potential who agree to use medically accepted contraception\* during the clinical trial period. (\*Hormonal contraception, intrauterine device (IUD) or intrauterine system (IUS), tubal ligation, double-barrier methods (such as combining cervical cap or diaphragm with male condom), or single-barrier methods combined with spermicide).
• Subjects who have received a detailed explanation of this clinical trial, understand it, voluntarily decide to participate, and provide written consent.
• For women of childbearing potential, individuals who test negative for pregnancy prior to the administration of the investigational product.

You may not qualify if:

• Subjects with localized wounds or active infections (such as cysts, acne, rashes, hives, etc.) in the nasolabial fold area.
• Subjects with acute, chronic, or recurrent skin conditions (whether infectious or non-infectious).
• Subjects with scars or abnormal skin findings (such as moles, erythema, or telangiectasia) in the nasolabial fold area that may affect treatment outcomes.
• Subjects with a history of keloid formation, hyperpigmentation, or hypertrophic scars.
• Subjects with a history of bleeding disorders (such as liver disease, clotting factor deficiencies, etc.).
• Subjects with a history of herpetic rash.
• Subjects with connective tissue diseases, autoimmune diseases, or suspected immune deficiencies (such as Sjögren's syndrome, systemic lupus erythematosus, etc.).
• Subjects with active sepsis, sarcoidosis, infective endocarditis, or confirmed infections regardless of location, type, or size.
• Subjects with known allergies or hypersensitivity reactions, either localized or systemic, to the components of the investigational medical device or amide-type local anesthetics.
• Subjects who tested positive in skin patch tests for either the investigational device or control device.
• Subjects with a significant history of allergies or anaphylaxis that could affect this clinical trial.
• Subjects with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous systems.
• Subjects with a history of malignancy within 5 years of screening (except for those with basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, thyroid cancer, or prostate cancer, provided there has been no recurrence for over 3 years after complete remission, as judged by the investigator).
• Subjects suffering from untreated epilepsy.
• Subjects suffering from porphyria.

Sponsors & Collaborators

• DEXLEVO: lead

Study Sites (1)

Societatea Civila Medicala Dr. Rosu

Romania, Timisoara, 10 Cozia Street, Building A,, Romania

Location

Central Study Contacts

Mihaela Fratila investigator

CONTACT

+40 740 211 991; fratila31@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant, Investigator are blinded to treatment assignment to each side of their faces.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 20, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-02

Locations

RO (1)