Skin AgingNCT03677258
Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy
A study testing Collagen for injections 7% and Hyaluronic acid for injections 2% in people with Skin Aging, run by Nearmedic Plus LLC at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Collagen for injections 7% and Hyaluronic acid for injections 2%
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 25 Oct 2017to 8 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study: Collagen Anti-age Treatment in Routine Clinical Practice
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.
Read the 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
- Conditions
- Skin Aging
- Being tested
- Collagen for injections 7%, Hyaluronic acid for injections 2%
- Keywords
- Collagen, anti-age therapy, cosmetology, lifting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen for injections 7%Device
Also called Collost
Injection of medical device
Hyaluronic acid for injections 2%Device
Also called Viscoderm
Injection of medical device
| Study group | Role | What they receive |
|---|---|---|
| Collagen injections | Experimental | 30 females with aging facial problems from 35 to 65 years old prescribed collagen ingection once every 3 weeks, cours of therapy - 3 procedures Receives: Device: Collagen for injections 7% |
| Hyaluronic acid injections | Active comparator | 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 Receives: Device: Hyaluronic acid for injections 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
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
Measured: 3 months
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
Measured: 3 months
3D photo materials after injections of the Collagen and after injections of the Hyaluronic Acid
To evaluete results of procedures by the Quantifirecare data
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start25 Oct 2017
- Primary completion15 Apr 2018
- Study completion8 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nearmedic Plus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute of Plastic Surgery and Cosmetology, Moscow, Russia
- Responsible party
- Sponsor
- Investigators
- Anna Stenko, PhD, Principal investigator, Institute of Plastic Surgery and Cosmetology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677258
- Sponsor's protocol ID
- COLLOST postmarketing study
- Status last verified
- Sep 2018
- First submitted
- 25 Apr 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study: Collagen Anti-age Treatment in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03677258
- Acronym / sponsor ID
- COLLOST postmarketing study
- Conditions
- Skin Aging
- Keywords
- Collagen, anti-age therapy, cosmetology, lifting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nearmedic Plus LLCIndustry (pharma, biotech, devices)
- Collaborators
- Institute of Plastic Surgery and Cosmetology, Moscow, Russia
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 8 Jul 2018 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen injections | Experimental | Device: Collagen for injections 7%30 females with aging facial problems from 35 to 65 years old prescribed collagen ingection once every 3 weeks, cours of therapy - 3 procedures |
| Hyaluronic acid injections | Active comparator | Device: Hyaluronic acid for injections 2%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 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- signed Inform Consent Form
- only females
- from 35 to 65 years old
- 1-3 skin photo types
- signs of age-related skin changes
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen for injections 7%Also: CollostInjection of medical device | Device | Collagen injections |
| Hyaluronic acid for injections 2%Also: ViscodermInjection of medical device | Device | Hyaluronic acid injections |
Primary outcome
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
Time frame: 3 months
To evaluate elasticity in Cheek, in forehead and glabella area scanned after each procedure and compare with screening results
4 secondary outcomes
Safety: to evaluate safety by comparing adverse events after injections of the Collagen and after injections of the Hyaluronic Acid
Time frame: 3 months
Microcirculation data after injections of the Collagen and after injections of the Hyaluronic Acid
Time frame: 3 months
3D photo materials after injections of the Collagen and after injections of the Hyaluronic Acid
Time frame: 3 months
GAIS scale data after injections of the Collagen and after injections of the Hyaluronic Acid
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Stenko, PhD principal investigator
Institute of Plastic Surgery and Cosmetology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen for injections 7% and Hyaluronic acid for injections 2% in people with Skin Aging, run by Nearmedic Plus LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.