The aim of this first-in-human clinical study is to explore the safety, tolerability, pharmacodynamics, and exploratory efficacy of PIEZO-101, an investigational plasmid DNA biostimulator that aims to restore expression of key proteins in the skin for extracellular matrix rejuvenation. PIEZO-101 is administered using an intradermal injection followed by localized electroporation using the investigational device Piezopen. This clinical trial will study safety and tolerability, pharmacodynamics using biopsies from the left knee, and exploratory efficacy using photography on the décolleté. Up to 8 participants may be enrolled to ensure 6 evaluable participants complete the study.
Healthy female adults aged 40-65 years
Fitzpatrick skin phototype score I-IV
Visible signs of skin laxity, wrinkling, or crepiness in the knee area, confirmed by photographic documentation reviewed by at least two independent assessors
Visible signs of wrinkling or crepiness in the décolleté area suitable for standardized photography, free of tattoos, significant scarring, or confounding skin conditions in the photography field, confirmed by photographic documentation reviewed by at least two independent assessors
History of keloid or hypertrophic scarring
Known allergy or hypersensitivity to any antibiotic
Known hypersensitivity to lidocaine, prilocaine, or any component of the topical anesthetic preparation
Active dermatologic conditions or infections (such as psoriasis, eczema, active acne, or dermatitis) in the knee or décolleté treatment areas