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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677258
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Institute of Plastic Surgery and Cosmetology, Moscow, Russia
Information provided by (Responsible Party):
Nearmedic Plus LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Skin Aging Device: Collagen for injections 7% Device: Hyaluronic acid for injections 2% Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-interventional Study: Collagen Anti-age Treatment in Routine Clinical Practice
Actual Study Start Date : October 25, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : July 8, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Viscoderm




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Anti-aging therapy more popular for female patients
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677258


Locations
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Russian Federation
Institute of Plastic Surgery and Cosmetology
Moscow, Russian Federation, 105066
Sponsors and Collaborators
Nearmedic Plus LLC
Institute of Plastic Surgery and Cosmetology, Moscow, Russia
Investigators
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Principal Investigator: Anna Stenko, PhD Institute of Plastic Surgery and Cosmetology
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Responsible Party: Nearmedic Plus LLC
ClinicalTrials.gov Identifier: NCT03677258    
Other Study ID Numbers: COLLOST postmarketing study
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nearmedic Plus LLC:
Collagen
anti-age therapy
cosmetology
lifting
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents