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
Parallel
PIEZO-101
Biological/VaccinePlasmid DNA biostimulator
Piezopen
DeviceIntradermal electroporation device
Sterile Saline (0.9% NaCl)
Other interventionIntra-participant comparator (control)
Safety and tolerability of intradermal delivery of PIEZO-101 followed by Piezopen EP
Described via Common Terminology Criteria for Adverse Events (CTCAE) v6.0 through Day 90, including clinical laboratory assessments (hematology, serum chemistry, inflammatory markers) and vital signs
Characterize local tissue responses in treatment (PIEZO-101 + Piezopen EP) and control (saline) sites
Scoring to characterize tissue responses such as erythema, edema, bruising, induration, pain, and itching after treatment application
Describe Piezopen EP procedural tolerability
Scoring to describe pain level of procedure
Explore transgene mRNA expression 7 days after each dose
Characterization of PIEZO-101-treated biopsy versus saline-treated biopsy via qPCR assay
Describe protein-level pharmacodynamic evidence in biopsy specimens from treated vs control sites
Characterization of PIEZO-101 and saline groups for extracellular matrix protein expression via immunofluorescence and histological changes using standardized stains, performed on respective biopsies
Explore aesthetic improvements over time
Characterization of changes in skin quality and wrinkle severity over time relative to baseline using GAIS scale, scored by blinded independent assessor and participant self-assessment
Describe anti-drug antibody (ADA) immunogenicity
Explore whether PIEZO-101 with Piezopen EP elicits any anti-drug antibody responses in participants using ELISA
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