Linalool Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial sponsored by the National Allergy Research Center Denmark is currently not yet recruiting to evaluate allergic contact dermatitis associated with linalool. Classified under a non-applicable trial phase, the investigation utilizes a repeated open application test to assess dermatological responses to linalool-derived hydroperoxides. Broadly, clinical research focuses on evaluating dermatological sensitivity and contact allergy profiles associated with oxidation products of this monoterpene compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05858723	Not yet recruiting	Allergic Contact Dermatitis	National Allergy Research Center Denmark	2023-08	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Linalool acts as a competitive antagonist of N-methyl-D-aspartate (NMDA) receptors, blocking endogenous ligand binding and subsequently suppressing downstream calcium influx and excitatory cascades. This inhibition attenuates cellular excitability and neurogenic signaling, which is directly relevant to investigating cutaneous neurogenic inflammation and contact sensitivity responses observed in allergic contact dermatitis.

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>).