Study of the Subdermal Implant "Algeness" | NCT07618468 | Trialant

Study of the Subdermal Implant "Algeness" | NCT07618468 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Device: Algeness Subdermal Implant (Agarose)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	Baseline (Visit 1, Day 0), Visit 2, Visit 3, Visit 4 post-injection (within 90 days)

Contacts/Locations Module

Condition Browse Module