NCT03677258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

April 25, 2018

Last Update Submit

September 17, 2018

Conditions

Skin Aging

Keywords

Collagenanti-age therapycosmetologylifting

Outcome Measures

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

    3 months

Secondary Outcomes (4)

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

    3 months

  • Microcirculation data after injections of the Collagen and after injections of the Hyaluronic Acid

    3 months

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

    3 months

  • GAIS scale data after injections of the Collagen and after injections of the Hyaluronic Acid

    3 months

Study Arms (2)

Collagen injections

EXPERIMENTAL

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%

Hyaluronic acid injections

ACTIVE COMPARATOR

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

Collagen for injections 7%DEVICE

Injection of medical device

Also known as: Collost
Collagen injections
Hyaluronic acid for injections 2%DEVICE

Injection of medical device

Also known as: Viscoderm
Hyaluronic acid injections

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAnti-aging therapy more popular for female patients
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed Inform Consent Form
  • only females
  • from 35 to 65 years old
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Plastic Surgery and Cosmetology

Moscow, 105066, Russia

Location

Study Officials

  • Anna Stenko, PhD

    Institute of Plastic Surgery and Cosmetology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

September 19, 2018

Study Start

October 25, 2017

Primary Completion

April 15, 2018

Study Completion

July 8, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Locations

RU(1)