Safety and effectiveness of Lunafill Ultra intradermal injectable gel for correcting nasolabial folds
- Conditions
- Skin aging.
- Registration Number
- IRCT20150101020514N11
- Lead Sponsor
- Zist orchid pharmed Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
18 -65 years old men and women
Moderate to severe nasolabial folds
Signing the infirmed consent form
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
Allergy or sensitivity to lidocaine, hyaluronic acid products
Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region
Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections
People prone to hypertrophic scar formation
History of ant auto immune or immune deficiency diseases or using any immune suppressive drug
Pregnancy and breast feeding
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 that and 2 weeks, 3 and 6 months later. Method of measurement: 5 scale Allergan phot numeric grading.
- Secondary Outcome Measures
Name Time Method Depth, area and volume of nasolabial fold. Timepoint: Before intervention and right after that and 2 weeks, 3 and 6 months later. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention and 2 weeks and 6 months later. Method of measurement: Skin ultrasound.