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

Nearmedic Plus LLC60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Aging

Interventions

Collagen for injections 7%DEVICE

Injection of medical device

Hyaluronic acid for injections 2%DEVICE

Injection of medical device

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institute of Plastic Surgery and Cosmetology

Moscow, Russia

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3 months

Data from ClinicalTrials.gov

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