Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy

Study Overview
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Brief Summary
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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
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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

Official Title
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Non-interventional Study: Collagen Anti-age Treatment in Routine Clinical Practice

Conditions
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Skin Aging

Intervention / Treatment
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* Device: Collagen for injections 7%
* Device: Hyaluronic acid for injections 2%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen injections<br>30 females with aging facial problems from 35 to 65 years old prescribed collagen ingection once every 3 weeks, cours of therapy - 3 procedures | Device: Collagen for injections 7%<br>* Injection of medical device<br>* Other names: Collost;|
| Active Comparator: Hyaluronic acid injections<br>30 females with aging facial problems from 35 to 65 years old prescribed hyaluronic acid ingection once every 3 weeks, cours of therapy - 3 procedures | Device: Hyaluronic acid for injections 2%<br>* Injection of medical device<br>* Other names: Viscoderm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | To evaluate elasticity in Cheek, in forehead and glabella area scanned after each procedure and compare with screening results | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: to evaluate safety by comparing adverse events after injections of the Collagen and after injections of the Hyaluronic Acid | To evaluate safety by comparing adverse events and their relationships with medical devices | 3 months | 
| Microcirculation data after injections of the Collagen and after injections of the Hyaluronic Acid | To evaluate results after each procedure and after 3 procedures by the laser Doppler fluorimetry | 3 months | 
| 3D photo materials after injections of the Collagen and after injections of the Hyaluronic Acid | To evaluete results of procedures by the Quantifirecare data | 3 months | 
| GAIS scale data after injections of the Collagen and after injections of the Hyaluronic Acid | To evaluete results of 1 procedures and after 3 procedures by the patient and by the doctor | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Collagen, anti-age therapy, cosmetology, lifting