Safety and effectiveness assessment of Nuxiwell gel produced for nasolabial folds correctio
Phase 2
Recruiting
- Conditions
- Skin aging.
- Registration Number
- IRCT20150101020514N16
- Lead Sponsor
- Amitis Nik Darou co.
- 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 infirmed 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 month 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 right after intervention and 2, 12 and 24 weeks later. Method of measurement: 5 scale Allergan photonumeric grading.
- Secondary Outcome Measures
Name Time Method Depth, area and volume of nasolabial fold. Timepoint: Before intervention and right after intervention and 2, 12 and 24 weeks later. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention and right after intervention and 2, 12 and 24 weeks later. Method of measurement: Skin ultrasound.