Evaluating of safety and efficacy of Stylux Voluma dermal filler

Phase 2

Recruiting

Conditions: asolabial folds.
Changes in skin texture
R23.4

Registration Number: IRCT20190210042676N32

Lead Sponsor: ovajen Daru

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

18 -65 years old men and women
Moderate to severe nasolabial folds based on Allergan criteria.
The opportunity to accompany the visit programs and study process
Signing the informed consent form and agree to a 6-month follow-up.

Exclusion Criteria

Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment.
Cosmetic facial procedures (chemical peel, laser, radio frequency, dermabrasion, ablative or non-ablative procedures), Botox) in the lower 2/3 of the face, within 3 months prior to study entry
Planning to undergo any of these procedures at any time during the study.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of nasolabial folds. Timepoint: Before intervention and 2 weeks later. Method of measurement: 5 scale Allergan photo numeric grading.

Secondary Outcome Measures

Name	Time	Method
Depth, area and volume of nasolabial fold. Timepoint: Before intervention, 2 weeks, 3 and 6 months after intervention. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention, 2 weeks and 6 months after intervention. Method of measurement: Skin ultrasound.