An interventional study of Algeness Subdermal Implant (Agarose) in Skin Aging, Facial Wrinkles and Soft Tissue Volume Loss, sponsored by Estelab Clinic. Completed at 1 site in Russia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Estelab Clinic · Not applicable, Interventional, and Treatment
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.
139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.
This study's enrollment of 40 is below the median of 46 across 97 interventional studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →Estelab Clinic is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
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).
Time frame: Baseline (Visit 1, Day 0), Visit 2, Visit 3, Visit 4 post-injection (within 90 days)
Ran from Jun 2024 to primary completion in Apr 2025, 10 months.
Of 23 interventional studies with no phase under Lipodystrophy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's 10 months is close to that.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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