Procyanidin C1 Clinical Trials

Size	Price	Qty
5mg	USD 670
25mg	USD 2,009

Clinical Trials

Clinical research on Procyanidin C1 (PCC1) remains preliminary, with a clinical trial evaluating its therapeutic utility for skin rejuvenation in healthy volunteers. Sponsored by Express Rx, Inc., this open-label, randomized investigation was conducted without a formal phase designation and has completed recruitment. Consequently, clinical evidence for PCC1 is currently limited to evaluating human skin rejuvenation and related dermatological applications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06641869	COMPLETED	Skin Rejuvenation	Express Rx, Inc	2022-10-10

(data from https://clinicaltrials.gov, updated on 2025-08-11)

Check the Procyanidin C1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Procyanidin C1 acts as a natural polyphenolic senotherapeutic agent that targets senescent cells to induce their selective clearance, thereby reducing the pro-inflammatory senescence-associated secretory phenotype and downstream tissue degradation. By selectively eliminating senescent cells and restoring cellular homeostasis, this mechanism helps attenuate age-related dermal dysfunction, providing a rational basis for its clinical investigation in skin rejuvenation.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).