Skin AgingNCT07618468
Study of the Subdermal Implant "Algeness"
A study testing Algeness Subdermal Implant (Agarose) in people with Skin Aging and Facial Wrinkles, run by Estelab Clinic at 1 site in Russia.
Trial summary
A single-center clinical study of the efficacy and safety of the medical device "Algeness subdermal implant based on agarose (Ghimas SpA/Ghimas SpA, Italy) in the correction of skin contour defects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Facial Wrinkles, Soft Tissue Volume Loss
- What is being tested?
- Algeness Subdermal Implant (Agarose)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 8 Jun 2024to 10 Apr 2025
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 30 and 65 years inclusive
- Presence of signs of age-related facial skin changes (decreased turgor, elasticity, fine wrinkles, contour defects)
- Signed informed voluntary consent
- Willingness and ability to comply with study procedures and attend all scheduled visits
Who cannot join
- Age under 18 years
- Individual intolerance or allergy to any component of the investigational device
- Diagnosed tendency to keloid or hypertrophic scarring
- Severe chronic diseases in the acute phase
- Acute forms of dermatological diseases
- Coagulation disorders
Show all 14Show fewer
- Treatment with medications affecting blood coagulation
- Inflammatory or infectious processes in the injection zones
- Diagnosed autoimmune pathologies
- Pregnancy and lactation period
- Filler injections in the same area within the past 12 months
- Laser procedures or chemical peels within the past 3 months
- Oncological diseases in history or at the time of inclusion
- Participation in another clinical study within the past 3 months
Trial locations and contacts
1 site in 1 country.
Russia1 site
Estelab Clinic (Clinical Base of FSBEI FPE Russian Medical Academy of Continuing Professional Education)
Moscow, 119034
About this study
Official title: A Single-center Clinical Study of the Efficacy and Safety of the Medical Device "Algeness Subdermal Implant Based on Agarose (Ghimas SpA/Ghimas SpA, Italy) in the Correction of Skin Contour Defects.
A single-center clinical study of the efficacy and safety of the medical device "Algeness subdermal implant based on agarose (Ghimas SpA/Ghimas SpA, Italy) in the correction of skin contour defects.
- Conditions
- Skin Aging, Facial Wrinkles, Soft Tissue Volume Loss, Lipoatrophy
- Being tested
- Algeness Subdermal Implant (Agarose)
- Keywords
- Agarose, dermal filler, Algeness, facial rejuvenation
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algeness Subdermal Implant (Agarose)Device
Slowly absorbable biocompatible hydrogel based on natural agarose (1.0-3.5%) with phosphate buffer. Four formulations: LD (1%), HD (1.5%), VL (2.5% with hyaluronate), DF (3.5% with hyaluronate). Gamma-sterilized 1.4 mL syringe, single use. Manufactured by GHIMAS S.p.A., Italy. Class III medical device. Indicated for correction of facial contour defects, wrinkles, and soft tissue volume loss.
| Study group | Role | What they receive |
|---|---|---|
| Algeness Subdermal Filler | Experimental | All 40 female subjects (mean age 40.5, range 22-64) received subdermal injections of Algeness using linear-retrograde technique. One of four formulations was selected based on lesion depth and location: LD (1% agarose, superficial subdermal), HD (1.5%, subdermal), VL (2.5%, deep subdermal), DF (3.5%, deep subdermal). Up to 10 syringes (1.4 mL each) per procedure. Follow-up: Visits 2, 3, and 4 post-implantation. Receives: Device: Algeness Subdermal Implant (Agarose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wrinkle Severity Rating Scale (WSRS) Score
Validated 5-point Wrinkle Severity Rating Scale (1 = absent, 5 = extreme) assessed by the investigator. A reduction of 1 or more points compared to baseline is considered clinically significant. Unit: Score on a scale (1-5).
Measured: Baseline (Visit 1, Day 0), Visit 2, Visit 3, Visit 4 post-injection (within 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start8 Jun 2024
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Estelab Clinic
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Chebotareva Yulia Yurievna, Estelab Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618468
- Sponsor's protocol ID
- 2023
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Clinical Study of the Efficacy and Safety of the Medical Device "Algeness Subdermal Implant Based on Agarose (Ghimas SpA/Ghimas SpA, Italy) in the Correction of Skin Contour Defects.
- ClinicalTrials.gov ID
- NCT07618468
- Acronym / sponsor ID
- 2023
- Conditions
- Skin Aging, Facial Wrinkles, Soft Tissue Volume Loss, Lipoatrophy
- Keywords
- Agarose, dermal filler, Algeness, facial rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Estelab ClinicResearch network
- Study start
- 8 Jun 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 1 Jun 2026 (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.
A single-center clinical study of the efficacy and safety of the medical device "Algeness subdermal implant based on agarose (Ghimas SpA/Ghimas SpA, Italy) in the correction of skin contour defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Algeness Subdermal Filler | Experimental | Device: Algeness Subdermal Implant (Agarose)All 40 female subjects (mean age 40.5, range 22-64) received subdermal injections of Algeness using linear-retrograde technique. One of four formulations was selected based on lesion depth and location: LD (1% agarose, superficial subdermal), HD (1.5%, subdermal), VL (2.5%, deep subdermal), DF (3.5%, deep subdermal). Up to 10 syringes (1.4 mL each) per procedure. Follow-up: Visits 2, 3, and 4 post-implantation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 30 and 65 years inclusive
- Presence of signs of age-related facial skin changes (decreased turgor, elasticity, fine wrinkles, contour defects)
- Signed informed voluntary consent
- Willingness and ability to comply with study procedures and attend all scheduled visits
Key exclusion criteria (14 listed)
- Age under 18 years
- Individual intolerance or allergy to any component of the investigational device
- Diagnosed tendency to keloid or hypertrophic scarring
- Severe chronic diseases in the acute phase
- Acute forms of dermatological diseases
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 |
|---|---|---|
| Algeness Subdermal Implant (Agarose)Slowly absorbable biocompatible hydrogel based on natural agarose (1.0-3.5%) with phosphate buffer. Four formulations: LD (1%), HD (1.5%), VL (2.5% with hyaluronate), DF (3.5% with hyaluronate). Gamma-sterilized 1.4 mL syringe, single use. Manufactured by GHIMAS S.p.A., Italy. Class III medical device. Indicated for correction of facial contour defects, wrinkles, and soft tissue volume loss. | Device | Algeness Subdermal Filler |
Primary outcome
Change in Wrinkle Severity Rating Scale (WSRS) Score
Time frame: Baseline (Visit 1, Day 0), Visit 2, Visit 3, Visit 4 post-injection (within 90 days)
Validated 5-point Wrinkle Severity Rating Scale (1 = absent, 5 = extreme) assessed by the investigator. A reduction of 1 or more points compared to baseline is considered clinically significant. Unit: Score on a scale (1-5).
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 1 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algeness Subdermal Implant (Agarose) in people with Skin Aging and Facial Wrinkles, run by Estelab Clinic 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 4 inclusion and 14 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 1 Jun 2026. 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?
Change in Wrinkle Severity Rating Scale (WSRS) Score (time frame: Baseline (Visit 1, Day 0), Visit 2, Visit 3, Visit 4 post-injection (within 90 days)). 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 1 Jun 2026.