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

Skin Aging Clinical Trial

Official title:

Non-interventional Study: Collagen Anti-age Treatment in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677258
• Other study ID #: COLLOST postmarketing study
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: July 8, 2018

Study information

• Verified date: September 2018
• Source: Nearmedic Plus LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 8, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Aging

Intervention

Device:
• Collagen for injections 7%
Injection of medical device
• Hyaluronic acid for injections 2%
Injection of medical device

Locations

Country	Name	City	State
Russian Federation	Institute of Plastic Surgery and Cosmetology	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Nearmedic Plus LLC	Institute of Plastic Surgery and Cosmetology, Moscow, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety: to evaluate safety by comparing adverse events after injections of the Collagen and after injections of the Hyaluronic Acid	To evaluate safety by comparing adverse events and their relationships with medical devices	3 months
Secondary	Microcirculation data after injections of the Collagen and after injections of the Hyaluronic Acid	To evaluate results after each procedure and after 3 procedures by the laser Doppler fluorimetry	3 months
Secondary	3D photo materials after injections of the Collagen and after injections of the Hyaluronic Acid	To evaluete results of procedures by the Quantifirecare data	3 months
Secondary	GAIS scale data after injections of the Collagen and after injections of the Hyaluronic Acid	To evaluete results of 1 procedures and after 3 procedures by the patient and by the doctor	3 months