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

Nearmedic

Status: Completed

Conditions: Skin Aging

Treatments: Device: Collagen for injections 7%; Device: Hyaluronic acid for injections 2%

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03677258

COLLOST postmarketing study

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Collagen injections

Experimental group

Description:

30 females with aging facial problems from 35 to 65 years old prescribed collagen ingection once every 3 weeks, cours of therapy - 3 procedures

Treatment:

Device: Collagen for injections 7%

Hyaluronic acid injections

Active Comparator group

Description:

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

Treatment:

Device: Hyaluronic acid for injections 2%