Skin Aging
Conditions
Keywords
Collagen, anti-age therapy, cosmetology, lifting
Brief summary
This study evaluates the statistics of anti-age treatment in outpatient sites in Russia (involution indicators: clinical scales; instrumental diagnostics, ultrasonic scannings, assesment of allergic state, efficacy assesment in according with GAIS scale) in routine clinical practice with focus on collagen therapy.
Detailed description
This non-interventional study covers 60 patients (females with involuntary changes of the face skin) from Russian sites. The following data will be collected and analyzed after the end of treatment: * demography * assessment of allergic state * safety data * severity of aging effect * clinical scales results before 1visit and after end of treatment * GAIS effectiveness assessment * instrumental diagnostic before 1visit and after end of treatment * hydration * elasticity * microcirculation level * lipofuscin level * ultrasound scanning * derma echo density
Interventions
DEVICECollagen for injections 7%
Injection of medical device
DEVICEHyaluronic acid for injections 2%
Injection of medical device
Sponsors
Institute of Plastic Surgery and Cosmetology, Moscow, Russia
Nearmedic Plus LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* signed Inform Consent Form * only females * from 35 to 65 years old * 1-3 skin photo types * signs of age-related skin changes * absence of chronic disease in decompensation phase * refusal to receive any cosmetic procedures during the study
Exclusion criteria
* pregnancy, lactation period * infection process, dermatoses, censers * systemic connective tissue diseases with skin and subcutaneous tissue damage * taking isotretinoin drugs for the previous 6 months * propensity to form hypertrophic and keloid scars * exacerbation or decompensation of chronic somatic diseases; infectious and oncological diseases * violations of blood coagulation, including iatrogenic (taking drugs that affect blood clotting) * taking antihistamines, glucocorticoids, NSAIDs, immunosuppressants and other drugs that affect the reactivity of the skin * hypersensitivity to the components of the studied medical device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elastisity Ultrasonic scanning of the scin - epidermis and dermis in 3 area of the face after injections of the Collagen and after injections of the Hyaluronic Acid | 3 months | To evaluate elasticity in Cheek, in forehead and glabella area scanned after each procedure and compare with screening results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: to evaluate safety by comparing adverse events after injections of the Collagen and after injections of the Hyaluronic Acid | 3 months | To evaluate safety by comparing adverse events and their relationships with medical devices |
| Microcirculation data after injections of the Collagen and after injections of the Hyaluronic Acid | 3 months | To evaluate results after each procedure and after 3 procedures by the laser Doppler fluorimetry |
| 3D photo materials after injections of the Collagen and after injections of the Hyaluronic Acid | 3 months | To evaluete results of procedures by the Quantifirecare data |
| GAIS scale data after injections of the Collagen and after injections of the Hyaluronic Acid | 3 months | To evaluete results of 1 procedures and after 3 procedures by the patient and by the doctor |
Countries
Russia
Outcome results
None listed