Econazole nitrate Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

A clinical trial sponsored by AmDerma Pharmaceuticals LLC evaluated topical Econazole nitrate in patients presenting with interdigital tinea pedis, commonly known as athlete's foot. This completed Phase 2, multicenter study was designed as a randomized comparative trial evaluating the pharmacokinetics of a foam formulation against an established cream preparation. Currently, no additional clinical trials are recorded for this compound across other indications or trial phases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01696799	Completed	Interdigital Tinea Pedis	AmDerma\|AmDerma Pharmaceuticals LLC	2011-09	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Econazole nitrate functions as an imidazole antifungal agent and calcium channel blocker that inhibits fungal 14α-demethylase, thereby suppressing ergosterol biosynthesis and calcium influx. The resulting disruption of fungal cell membrane integrity leads to cell death, providing the biological mechanism responsible for clearance of dermatophyte infections such as interdigital tinea pedis.

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>).