Efficacy and safety of non-cross-linked hyaluronic acid containing exosomes derived from fibroblast cells foreskin in rejuvenating the skin around the eyes in humans
Phase 1
- Conditions
- skin rejuvenation.
- Registration Number
- IRCT20221130056672N5
- Lead Sponsor
- Research Vice President of Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
The age of these people to enter the study is between 35 and 45 years old.
The skin around the eyes (crow's feet area) of patients has lost its original properties and started to wrinkle.
Exclusion Criteria
Allergy to injections and syringes
People who participate in this study should not have used rejuvenation methods such as Botox 4 to 6 months before the start of the study and injections.
Hypersensitivity to non-crosslinked hyaluronic acid
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rejuvenation of crow's feet skin around the eyes. Timepoint: Changes in the mentioned area are measured 4 weeks, 8 weeks, and 12 weeks after the injection, and 8 weeks after the last injection (20 weeks from the day of injection), final examinations are performed. Method of measurement: 1- Visio face: a full-face photography method for facial skin analysis, optimal product recommendation and treatment documentation. Using this method, before and after the skin and the surface and depth of wrinkles are measured. 2- Colorimeter: The colorimeter contains a photocell that is able to detect the amount of light passing through the investigated solution. As a result, the color is checked before and after the end of the test so that a diagnosis can be made in case of lightening of the skin. 4- Sonography: This test is also used to measure thickness and density.
- Secondary Outcome Measures
Name Time Method Safety. Timepoint: Checks for safety are done one week after each injection and before the time of re-injection. Method of measurement: Patient history and lack of swelling in the injection area.