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Completed

NCT Number: NCT03677258

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

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.

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Key information

Conditions

Skin Aging

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Plastic Surgery and Cosmetology

Moscow, 105066, Russia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagen for injections 7%

Device

Injection of medical device

Other names: Collost

Hyaluronic acid for injections 2%

Device

Injection of medical device

Other names: Viscoderm

Primary outcomes

  1. 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

    Time frame: 3 months

    To evaluate elasticity in Cheek, in forehead and glabella area scanned after each procedure and compare with screening results

Secondary outcomes

  1. Safety: to evaluate safety by comparing adverse events after injections of the Collagen and after injections of the Hyaluronic Acid

    Time frame: 3 months

    To evaluate safety by comparing adverse events and their relationships with medical devices

  2. Microcirculation data after injections of the Collagen and after injections of the Hyaluronic Acid

    Time frame: 3 months

    To evaluate results after each procedure and after 3 procedures by the laser Doppler fluorimetry

  3. 3D photo materials after injections of the Collagen and after injections of the Hyaluronic Acid

    Time frame: 3 months

    To evaluete results of procedures by the Quantifirecare data

  4. GAIS scale data after injections of the Collagen and after injections of the Hyaluronic Acid

    Time frame: 3 months

    To evaluete results of 1 procedures and after 3 procedures by the patient and by the doctor

Sponsors and collaborators

Lead sponsor

Nearmedic Plus LLC

Industry

Collaborators

  • Institute of Plastic Surgery and Cosmetology, Moscow, Russia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 19, 2018
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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