Purpose of This Study is the Demonstration of Safety and Efficacy of the Dermal Fillers DXP01 Tem… (NCT06885775) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Purpose of This Study is the Demonstration of Safety and Efficacy of the Dermal Fillers DXP01 Temporary Improvement of Moderate to Severe Nasolabial Folds
Romania80 participantsStarted 2025-04-28
Plain-language 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
Who can participate
Age range19 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
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.
. 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.