About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DXP01
- Juvederm ULTRA 3
Treatment groups
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.