PIEZO-101 First-in-Human Safety and Proof-of-Concept Study (NCT07671027) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
PIEZO-101 First-in-Human Safety and Proof-of-Concept Study
8 participantsStarted 2026-09
Plain-language summary
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.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Willingness to undergo all protocol-required skin punch biopsies (four at Day 7 and four at Day 35) from the knee area
. Willingness to abstain from other aesthetic or dermatologic treatments in the knee and décolleté areas during the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of intradermal delivery of PIEZO-101 followed by Piezopen EP
. For women of childbearing potential (WOCBP): commitment to use a highly effective method of contraception (combined hormonal contraception, progestogen-only contraception, intrauterine device or hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence) from the Screening Visit through the Day 90 End-of-Study visit. Postmenopausal status, defined as ≥12 months of natural amenorrhea, is not considered childbearing potential.
. Negative serum β-hCG pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test at the treatment visits (Visit 2 and Visit 6) prior to dose for participants of child-bearing potential
Exclusion criteria
. 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
. History of knee surgery or significant scarring in the knee treatment area; history of breast augmentation, reduction, or surgery resulting in scarring in the décolleté treatment area
. Use of systemic corticosteroids, immunosuppressants, or medications affecting wound healing within 30 days of Day 0