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

NCT ID: NCT03677258

Last Updated: 2018-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-25

Study Completion Date

2018-07-08

Brief Summary

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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.

Detailed Description

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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

Conditions

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Skin Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Collagen for injections 7%

Intervention Type DEVICE

Injection of medical device

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

Group Type ACTIVE_COMPARATOR

Hyaluronic acid for injections 2%

Intervention Type DEVICE

Injection of medical device

Interventions

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Collagen for injections 7%

Injection of medical device

Intervention Type DEVICE

Hyaluronic acid for injections 2%

Injection of medical device

Intervention Type DEVICE

Other Intervention Names

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Collost Viscoderm

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Plastic Surgery and Cosmetology, Moscow, Russia

UNKNOWN

Sponsor Role collaborator

Nearmedic Plus LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Stenko, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Plastic Surgery and Cosmetology

Locations

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Institute of Plastic Surgery and Cosmetology

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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COLLOST postmarketing study

Identifier Type: -

Identifier Source: org_study_id

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