Benzyl alcohol Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple Phase 3 and Phase 4 clinical trials evaluate benzyl alcohol formulations for dermatological parasitic infestations, primarily targeting scabies and pediculosis. Sponsored by industry organizations such as ParaPRO LLC and Concentrics Research, these completed and actively recruiting studies focus on pediatric pharmacokinetic and safety profiles. Ultimately, this research aims to confirm the safety, tolerability, and efficacy of topical therapies for ectoparasitic diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05310734	Recruiting	Scabies	ParaPRO LLC\|Concentrics Research\|Iqvia Pty Ltd\|Medpace Inc.\|Inotiv Laboratories\|BioAgilytix	2022-03-04	Phase 4
NCT02485717	Completed	Scabies	ParaPRO LLC\|Concentrics Research	2017-05-02	Phase 3
NCT01660321	Completed	Pediculosis	ParaPRO LLC	2011-09	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Benzyl alcohol functions by interacting with neuronal cell membranes and voltage-gated sodium channels, thereby blocking sodium ion influx and disrupting nerve action potential propagation. This nerve conduction blockade causes local anesthetic effects and leads to respiratory obstruction or paralysis in target organisms, providing clinical utility in managing scabies and pediculosis infestations.

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>).