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CompletedNCT03677258Updated Sep 19, 2018

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

An interventional study of Collagen for injections 7% and Hyaluronic acid for injections 2% in Skin Aging, sponsored by Nearmedic Plus LLC. Completed at 1 site in Russian Federation. Open to female participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-19.

Sponsored by Nearmedic Plus LLC · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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
02

Conditions studied

  • Skin Aging

Keywords

  • Collagen
  • anti-age therapy
  • cosmetology
  • lifting
03

In context

Lead sponsor

Nearmedic Plus LLC is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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%

  • 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%

Interventions

  • DeviceCollagen for injections 7%

    Injection of medical device

    Also known as: Collost

  • DeviceHyaluronic acid for injections 2%

    Injection of medical device

    Also known as: Viscoderm

06

What researchers measure

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

    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

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
  • Institute of Plastic Surgery and Cosmetology
    Moscow, 105066, Russian Federation
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03677258
Lead sponsor
Nearmedic Plus LLC
Collaborators
Institute of Plastic Surgery and Cosmetology, Moscow, Russia
Responsible party
Sponsor
First posted
Sep 19, 2018
Start date
Oct 25, 2017
Primary completion
Apr 15, 2018
Completion
Jul 8, 2018
Last update
Sep 19, 2018

Study contacts

Anna Stenko, PhD
principal investigator · Institute of Plastic Surgery and Cosmetology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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