Safety and efficacy assessment of injectable gel with Perleux® brand, in order to rejuvenate facial ski
Phase 2
Recruiting
- Conditions
- Skin Hydration.
- Registration Number
- IRCT20150101020514N17
- Lead Sponsor
- Zist orchid pharmed Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
35 -60 years old men and women
The presence of visible signs of skin aging mainly dry skin, skin roughness, loss of elasticity and clear lines and wrinkles.
Have signed 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
History of radiofrequency (R-F), rejuvenation lasers or intense pulsed light in the past 6 months
Pregnancy or lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skin elasticity (R0, R2, R5) measured in right cheek. Timepoint: Before intervention, 8 and 16 weeks later. Method of measurement: By cutometer probe of MPA 580(Multi Probe Adaptor) device.
- Secondary Outcome Measures
Name Time Method Thickness and density of dermis. Timepoint: Before intervention, 8 and 16 weeks later. Method of measurement: Skin ultrasound.;Trans Epidermal Water Lost (TEWL) measured in right cheek. Timepoint: Before intervention, 8 and 16 weeks later. Method of measurement: By TEWA probe of MPA 580(Multi Probe Adaptor) device.