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

September 17, 2018 updated by: Nearmedic Plus LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 105066
        • Institute of Plastic Surgery and Cosmetology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collagen injections
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%
Injection of medical device
Other Names:
  • Collost
Active Comparator: Hyaluronic acid injections
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%
Injection of medical device
Other Names:
  • Viscoderm

What is the study measuring?

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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
To evaluete results of 1 procedures and after 3 procedures by the patient and by the doctor
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nearmedic Plus LLC

Collaborators

Institute of Plastic Surgery and Cosmetology, Moscow, Russia

Investigators

  • Principal Investigator: Anna Stenko, PhD, Institute of Plastic Surgery and Cosmetology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

April 15, 2018

Study Completion (Actual)

July 8, 2018

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLLOST postmarketing study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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