Clinical Trials

A clinical trial evaluated a daily topical sertaconazole nitrate formulation for superficial fungal dermatoses, specifically targeting interdigital tinea pedis, athlete's foot, foot fungus, and ringworm. Sponsored by collaborative academic and industry entities, including Jamaica Hospital Medical Center and Johnson & Johnson, this Phase 3 study currently has an unknown recruitment status. Overall, clinical research efforts for this compound remain focused on evaluating topical antifungal regimens for superficial cutaneous infections.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00856596 Unknown status
Tinea Pedis|Athlete''s Foot|Foot Fungus|Ringworm
Jamaica Hospital Medical Center|Johnson & Johnson
 2009-03 Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sertaconazole nitrate inhibits fungal lanosterol 14-alpha-demethylase, which blocks ergosterol biosynthesis and disrupts the structural integrity and permeability of the fungal plasma membrane. This destabilization leads to fungal cell lysis and growth inhibition, providing the therapeutic mechanism for resolving superficial cutaneous infections such as tinea pedis, athlete's foot, and ringworm studied in clinical trials.

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.