Clinical trial NCT03677258: Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy
Official title: Non-interventional Study: Collagen Anti-age Treatment in Routine Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Keywords: Collagen
anti-age therapy
cosmetology
lifting
Lead sponsor: Nearmedic Plus LLC
Sponsor class: INDUSTRY
Collaborators: name: Institute of Plastic Surgery and Cosmetology, Moscow, Russia
First posted: 2018-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Safety: to evaluate safety by comparing adverse events after injections of the Collagen and after injections of the Hyaluronic Acid
timeFrame: 3 months
measure: Microcirculation data after injections of the Collagen and after injections of the Hyaluronic Acid
timeFrame: 3 months
measure: 3D photo materials after injections of the Collagen and after injections of the Hyaluronic Acid
timeFrame: 3 months
measure: GAIS scale data after injections of the Collagen and after injections of the Hyaluronic Acid
timeFrame: 3 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute of Plastic Surgery and Cosmetology
Study officials:
affiliation: Institute of Plastic Surgery and Cosmetology
name: Anna Stenko, PhD
role: PRINCIPAL_INVESTIGATOR
References: