evaluate the safety and efficacy of Inshape X® intradermal filler
Phase 2
- Conditions
- Skin aging.
- Registration Number
- IRCT20150101020514N26
- Lead Sponsor
- ano Darou Pajouhan Pardis Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
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.
Exclusion Criteria
History of type 1 allergic reactions or anaphylaxis reactions
Previous allergy to filler and lidocaine ingredients
History of hypertrophic and colloid scars or bleeding disorders in the nasolabial region
Active inflammatory processes, infection, lesion (cancerous/noncancerous) in the nasolabial region
Pregnancy and lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of nasolabial folds. Timepoint: Before intervention and 4 weeks later. Method of measurement: 5 scale Allergan photo numeric grading.
- Secondary Outcome Measures
Name Time Method Severity of nasolabial folds. Timepoint: Before intervention, 3, 6 and 12 months later. Method of measurement: 5 scale Allergan photo numeric grading.;Severity of nasolabial folds. Timepoint: Before intervention, 1, 3, 6 and 12 months later. Method of measurement: Based on GAIS scale compared to base mode.;Depth, area and volume of nasolabial fold. Timepoint: Before intervention, 1, 6 and 12 months later. Method of measurement: Visioface camera.