Sodium L-Ascorbyl-2-Phosphate (SAP) Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

A completed clinical trial sponsored by an academic investigator at the University of Miami evaluated the efficacy and safety of a topical 5% Sodium L-Ascorbyl-2-Phosphate lotion for the treatment of acne vulgaris. Although the randomized, double-blind, placebo-controlled study had no formal phase designation, it established clinical data for localized dermatological application. Consequently, research on this compound highlights its therapeutic potential in managing inflammatory skin conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00714454	COMPLETED	Acne Vulgaris	University of Miami

(data from https://clinicaltrials.gov, updated on 2008-07-14)

Check the Sodium L-Ascorbyl-2-Phosphate (SAP) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium L-ascorbyl-2-phosphate functions as a stabilized precursor of ascorbic acid that scavenges reactive oxygen species and stimulates hepatocyte growth factor production, thereby mitigating oxidative cellular damage and enhancing collagen synthesis. By suppressing dermal oxidative stress and lipid oxidation within pilosebaceous units, this molecular mechanism contributes to the attenuation of localized inflammatory responses in acne vulgaris.

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>).