Safety and Preliminary Clinical Outcomes of Integrating Engineered Synthetic Lipid Vesicles (Biosomes) in a Skin Booster Protocol: A Prospective Observational Study

Background: Engineered synthetic lipid vesicles with biomimetic architecture have emerged as promising adjunctive agents in aesthetic medicine. Nevertheless, objective evidence evaluating their integration within standardized, minimally invasive skin booster protocols remains limited. The study aimed to assess the safety, tolerability, and preliminary clinical outcomes of incorporating engineered synthetic lipid vesicles (Biosomes) into a facial skin booster protocol. Methods: This prospective, single-center observational study included ten adult women aged 18–65 years. Participants received three treatment sessions at 21-day intervals, consisting of PRX PLUS application, microneedling and subsequent topical administration of engineered synthetic lipid vesicles (AnteAGE® Biosome Solution). Clinical assessments were conducted at baseline and 15 days after the final treatment session. Objective skin quality parameters were evaluated using the VISIA® and Visioscope systems. Results: The combined protocol demonstrated a favorable tolerability profile, with minimal pain, discomfort, and burning sensation. Significant improvements were observed in texture-related parameters, pigmentation features, and redness values. Texture feature counts and scores were reduced by 20.0% and 25.8%, respectively (p ≤ 0.009). Redness features and scores decreased by 42.3% and 33.3% (p ≤ 0.022). Pigmentation-related parameters also showed significant reductions, while wrinkle and UV-related outcomes exhibited limited or non-significant changes. Conclusions: The integration of engineered synthetic lipid vesicles into a topical skin booster protocol demonstrated favorable immediate tolerability and was associated with significant improvements in selected objective skin quality parameters. Although preliminary, these findings suggest the potential value of this approach and support the need for further controlled studies to confirm its efficacy and durability.

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Journal
Biomedicines
Published
2026-09-25
DOI
https://doi.org/10.3390/biomedicines14102172
Primary Topic
Advancements in Transdermal Drug Delivery
Type
article
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article

Safety and Preliminary Clinical Outcomes of Integrating Engineered Synthetic Lipid Vesicles (Biosomes) in a Skin Booster Protocol: A Prospective Observational Study

Robert J. Knight, Antonella Franceschelli, Deborah Subissati, Maria Luisa Garo et al.
Biomedicines
Advancements in Transdermal Drug Delivery
article

Safety and Preliminary Clinical Outcomes of Integrating Engineered Synthetic Lipid Vesicles (Biosomes) in a Skin Booster Protocol: A Prospective Observational Study

Robert J. Knight, Antonella Franceschelli, Deborah Subissati, Maria Luisa Garo, Michela Pallini, Alessandra Procaccini
article en

Abstract

Background: Engineered synthetic lipid vesicles with biomimetic architecture have emerged as promising adjunctive agents in aesthetic medicine. Nevertheless, objective evidence evaluating their integration within standardized, minimally invasive skin booster protocols remains limited. The study aimed to assess the safety, tolerability, and preliminary clinical outcomes of incorporating engineered synthetic lipid vesicles (Biosomes) into a facial skin booster protocol. Methods: This prospective, single-center observational study included ten adult women aged 18–65 years. Participants received three treatment sessions at 21-day intervals, consisting of PRX PLUS application, microneedling and subsequent topical administration of engineered synthetic lipid vesicles (AnteAGE® Biosome Solution). Clinical assessments were conducted at baseline and 15 days after the final treatment session. Objective skin quality parameters were evaluated using the VISIA® and Visioscope systems. Results: The combined protocol demonstrated a favorable tolerability profile, with minimal pain, discomfort, and burning sensation. Significant improvements were observed in texture-related parameters, pigmentation features, and redness values. Texture feature counts and scores were reduced by 20.0% and 25.8%, respectively (p ≤ 0.009). Redness features and scores decreased by 42.3% and 33.3% (p ≤ 0.022). Pigmentation-related parameters also showed significant reductions, while wrinkle and UV-related outcomes exhibited limited or non-significant changes. Conclusions: The integration of engineered synthetic lipid vesicles into a topical skin booster protocol demonstrated favorable immediate tolerability and was associated with significant improvements in selected objective skin quality parameters. Although preliminary, these findings suggest the potential value of this approach and support the need for further controlled studies to confirm its efficacy and durability.

BiomedicinesVol. 14(10)
University of Trieste (IT), University of California, Irvine (US), Saint Camillus International University of Health and Medical Sciences (IT)
Good health and well-being
Openalex Percentile: Top 13%
Advancements in Transdermal Drug Delivery
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