Evaluating the safety and effectiveness of injectable gel with the W&O XtraIII brand
Phase 2
Recruiting
- Conditions
- Skin aging.
- Registration Number
- IRCT20190210042676N30
- Lead Sponsor
- Ara Teb Gostar Soroush Company
- 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 right after intervention and 2, 12 and 24 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 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.