Clinical Trials

An observational clinical trial has evaluated the efficacy, safety, and tolerance of topical isoconazole nitrate cream preparations for treating skin mycoses. Industry sponsors, including LEO Pharma and Bayer, directed this research initiative, which lacks a designated trial phase and has completed recruitment. Ultimately, the study provides meaningful evidence regarding the topical management of superficial fungal infections.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00722189 Completed
Skin Mycoses
LEO Pharma|Bayer
 2008-07 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isoconazole nitrate inhibits fungal lanosterol 14α-demethylase, thereby blocking ergosterol biosynthesis and disrupting fungal cell membrane structure and permeability. This loss of membrane integrity suppresses fungal viability and cell growth, providing the mechanistic foundation for its therapeutic efficacy against skin mycoses.

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>).

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Note: Technical data last updated: Sep 1, 2026.