NCT06885775

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 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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: DEXLEVO · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Dermal Fillers
• Nasolabial Folds, Wrinkles

Interventions

Type	Name	Description
DEVICE	DXP01	PCL Dermal Filler
DEVICE	Juvederm ULTRA 3	HA Dermal filler

Timeline

• Start date: 2025-04-28
• Primary completion: 2027-04-01
• Completion: 2027-12-01
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

1 site across 1 country: Romania