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Dermal FillersPhase 2DXP01NCT06885775

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

A Phase 2 study testing DXP01 and Juvederm ULTRA 3 in people with Dermal Fillers and Nasolabial Folds, Wrinkles, run by DEXLEVO at 1 site in Romania.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Dermal Fillers, Nasolabial Folds, Wrinkles
What is being tested?
DXP01 and Juvederm ULTRA 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteRomania
Study dates
28 Apr 2025to 1 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.
  • Subjects with a history of alcohol or drug addiction.
  • Subjects with a history of psychiatric disorders that, in the investigator's opinion, could significantly affect this clinical trial.
  • Subjects who have undergone cosmetic procedures contraindicated for this clinical trial within 24 weeks of screening (except for upper eyelid surgery, rhinoplasty performed more than 24 months postoperatively, or lower eyelid correction).
  • Subjects who have undergone skin augmentation or permanent/semi-permanent implant-based cosmetic surgery (such as fillers based on CaHA, PLLA, PMMA, etc.) or PCL fillers or HA fillers on the face within 12 months of screening - CaHA (calcium hydroxyl apatite), PLLA (poly L-lactide), PMMA (polymethyl methacrylate), PCL (polycaprolactone), HA (Hyaluronic Acid)
  • Subjects who have taken any of the following medications within 1 week before the application of the investigational medical device or who are scheduled to take them within 3 days after application (however, if the medication is being taken at the time of screening and, in the investigator's judgment, a temporary discontinuation does not pose a medical risk, the individual may participate in the clinical trial after a 10-day wash-out period): *Anticoagulants, antiplatelet agents, thrombolytics (e.g., warfarin), oral/injectable corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) (low-dose aspirin up to 300 mg/day is permitted), and substances that delay blood coagulation time (such as vitamin E preparations of 400 IU/day or more, including multivitamins, garlic, and ginkgo biloba extracts).
  • Subjects who have received systemic corticosteroids or immune-suppressants within 12 weeks of screening.
  • Subjects who have applied oral or topical preparations or cosmetics with anti-wrinkle effects to the facial area within 12 weeks of screening (however, the use of sunscreen and certain cosmetics such as alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids, which have been continuously used for more than 90 days prior to screening, is permitted).
  • Subjects who have undergone chemotherapy within 12 weeks of screening.
  • Subjects who have received botulinum toxin injections in the face within 24 weeks of screening.
  • Subjects who have taken other investigational drugs or had investigational medical devices applied within 4 weeks of screening.
  • Pregnant women, women planning to become pregnant during the clinical trial period, or breastfeeding women.
  • Subjects who, for any other reason, are deemed unsuitable by the investigator for inclusion in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mihaela Fratila investigator contact

+40 740 211 991

fratila31@yahoo.com

Romania1 site

  • Societatea Civila Medicala Dr. Rosu

    Romania, Timisoara, 10 Cozia Street, Building A,

    +40 740 211 991, fratila31@yahoo.com

Other trials in Romania

About this study

Official title: A Multicenter, Randomized, Evaluator- and Subject-blinded, Active-controlled, Paired, Confirmatory Clinical Trial to Compare and Evaluate the Efficacy and Safety of DXP01 Versus Juvéderm® ULTRA 3 in Adults Requiring the Temporary Improvement of Moderate to Severe Nasolabial Folds

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

Read the detailed description

This is a prospective, multi-center, observational, two-arm, evaluator- and subject-blinded, active-controlled, paired clinical trial for demonstration of safety and efficacy of the dermal fillers DXP01 Face for restoration of moderate to severe nasolabial folds. Besides safety aspects, evaluated immediately after the treatment, 2 weeks, 8, 16, 24, 36 and 12 months after the treatment, the performance of the dermal fillers are evaluated in the 2, 8, 16, 24, 36 weeks and 12 months follow-up by using GAIS and WSRS.

Being tested
DXP01, Juvederm ULTRA 3
Keywords
NASOLABIAL FOLDS, DXP01

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DXP01Device

    PCL Dermal Filler

  • Juvederm ULTRA 3Device

    HA Dermal filler

Study groups in NCT06885775
Study groupRoleWhat they receive
Participant Group/ArmExperimentalDevice: 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.
Receives: Device: DXP01
TreatmentActive comparatorDevice: 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.
Receives: Device: Juvederm ULTRA 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.]

    Measured: Baseline and week 24

Secondary outcomes (4)

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

    • The mean value differences in the WSRS scores between group / The investigators calculated the mean value differences in the WSRS scores[Wrinkle severity assessment acc. to the Wrinkle Severity Rating Scale (WSRS); 1: wrinkles absent, 2: slight wrinkles, 3: moderate wrinkles, 4: severe wrinkles, 5: very severe wrinkles]

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

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

    • The mean value differences in the GAIS scores between group / The investigators calculated the mean value differences in the GAIS scores[GAIS: 3: very much improved, 2: much improved, 1: improved, 0 unchanged, -1: worse] between the test

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

  3. • Product safety 2 weeks~48 weeks

    • Short- and long-term adverse effects

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

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

    • The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start28 Apr 2025 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885775
Sponsor's protocol ID
DXP01_NFE-01
Acronym
DXP01
Status last verified
Feb 2025
First submitted
20 Feb 2025
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DXP01 and Juvederm ULTRA 3 in people with Dermal Fillers and Nasolabial Folds, Wrinkles, run by DEXLEVO at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mihaela Fratila investigator (+40 740 211 991, fratila31@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06885775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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