Clinical study to evaluate the safety and efficacy of Intella dermal filler for correction of nasolabial folds
- Conditions
- Skin aging.
- Registration Number
- IRCT20150101020514N27
- Lead Sponsor
- ESpadpharmed company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
18-65 year 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
History of type 1 allergic reactions or anaphylaxis reaction
Previous hyaluronic acid-based dermal filler injected within the last 12 months prior to enrollment.
History of hypertrophic and keloid scars or bleeding disorders in the nasolabial region
Active inflammatory processes, infection, lesions (cancerous/non-cancerous) in the nasolabial region
History of autoimmune diseases/immune deficiency or use of immunosuppressive medicines during the 6 months before entering the study or during the study
Pregnancy or lactation
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, 4, 12 and 24 weeks later. Method of measurement: 5 scale Allergan photo numeric grading.
- Secondary Outcome Measures
Name Time Method umber of people with at least one grade of reduction in the severity of both nasolabial folds. Timepoint: Before intervention and 3 and 6 months later. Method of measurement: scale Allergan photo numeric grading.;Depth, area and volume of nasolabial fold. Timepoint: Before intervention ,1 ,3 and 6 months later. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention ,1 and 6 months later. Method of measurement: Skin ultrasound.