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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-70
SponsorDEXLEVO

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

80 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Societatea Civila Medicala Dr. Rosu Status unavailable 10 Cozia Street, Building A,, Romania, TimisoaraRomaniaRomania

Sponsors and collaborators