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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03677258
Other study ID # COLLOST postmarketing study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2017
Est. completion date July 8, 2018

Study information

Verified date September 2018
Source Nearmedic Plus LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 8, 2018
Est. primary completion date April 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Collagen for injections 7%
Injection of medical device
Hyaluronic acid for injections 2%
Injection of medical device

Locations

Country Name City State
Russian Federation Institute of Plastic Surgery and Cosmetology Moscow

Sponsors (2)

Lead Sponsor Collaborator
Nearmedic Plus LLC Institute of Plastic Surgery and Cosmetology, Moscow, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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