Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy
NCT ID: NCT03677258
Last Updated: 2018-09-19
Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-10-25
2018-07-08
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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
Collagen for injections 7%
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
Hyaluronic acid for injections 2%
Injection of medical device
Interventions
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Collagen for injections 7%
Injection of medical device
Hyaluronic acid for injections 2%
Injection of medical device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
65 Years
FEMALE
Yes
Sponsors
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Institute of Plastic Surgery and Cosmetology, Moscow, Russia
UNKNOWN
Nearmedic Plus LLC
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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COLLOST postmarketing study
Identifier Type: -
Identifier Source: org_study_id
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