Clinical Trials

Numerous clinical trials evaluate the therapeutic efficacy and safety profile of miconazole nitrate across diverse indications, including vaginal candidiasis, otomycosis, oral mucositis, HIV infections, and fungal dermatoses. Spanning Early Phase 1 through Phase 4 as well as observational protocols, these studies are sponsored by academic institutions and industry entities. The majority of these trials have completed recruitment.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07311759 ACTIVE_NOT_RECRUITING
Chronic Paronychia
Cairo University
 2024-08-17 PHASE3
NCT05916729 UNKNOWN
Oral Candidiases
University of Belgrade
 2021-05-01 PHASE4
NCT05660382 COMPLETED
Otomycosis
Hill Dermaceuticals, Inc.
 2023-03-02 PHASE3
NCT06214273 UNKNOWN
Chemotherapy Induced Oral Mucositis
Cairo University
 2024-04 PHASE2
NCT04813822 UNKNOWN
Acute Vulvovaginal Candidiasis
Aesculape CRO Belgium BV
 2021-09-13 PHASE2
NCT04432376 COMPLETED
Otomycosis
Hill Dermaceuticals, Inc.
 2020-07-08 PHASE2; PHASE3
NCT04308161 UNKNOWN
Oral Mucositis Due to Radiation
Hams Hamed Abdelrahman
 2019-11-02 PHASE2
NCT04317183 UNKNOWN
Oral Mucositis Due to Chemotherapy
Hams Hamed Abdelrahman
 2019-05-15 PHASE2
NCT03130738 COMPLETED
Otomycosis
Hill Dermaceuticals, Inc.
 2017-04-20 PHASE2
NCT04442633 COMPLETED
Lichen Penis Planus
Hams Hamed Abdelrahman
 2019-04-01
NCT02515656 COMPLETED
Vaginitis
Laboratoire Innotech International
 2015-09 PHASE3
NCT02818803 COMPLETED
Candidiasis, Oral; Stomatitis, Denture
University of Sao Paulo
 2016-01 PHASE3
NCT02545452 COMPLETED
Endometriosis
Bayer
 2015-09-15 PHASE1
NCT02185456 UNKNOWN
Bacterial Vaginosis
Wayne State University
 2014-09 EARLY_PHASE1
NCT02215395 COMPLETED
Antifungal Drug Adverse Reaction
Population Council
 2014-03 PHASE1
NCT01661556 UNKNOWN
Melasma
Universidad Autonoma de San Luis Potosí
 2011-10 PHASE4
NCT03359070 COMPLETED
Tinea Cruris
Galeno Desenvolvimento de Pesquisas Clínicas
 2014-01-29 PHASE2
NCT01731574 COMPLETED
HIV
International Partnership for Microbicides, Inc.
 2012-12 PHASE1
NCT01230814 COMPLETED
Bacterial Vaginosis; Candidiasis; Trichomoniasis
National Institute of Allergy and Infectious Diseases (NIAID)
 2011-04 PHASE2
NCT00702507 COMPLETED
Diaper Rash
Stiefel, a GSK Company
 2007-05 PHASE4
NCT01769339 COMPLETED
Vulva; Candidiasis
Janssen Pharmaceutica
 2009-01 PHASE4
NCT00668538 COMPLETED
Healthy
University of Southern Denmark
 2008-04
NCT00668538 Completed
Healthy
University of Southern Denmark|Odense University Hospital
 2008-04 Not Applicable
NCT00390780 COMPLETED
HIV Infections
Valerio Therapeutics
 2006-07 PHASE3
NCT00390780 Completed
HIV Infections
Valerio Therapeutics
 2006-07 Phase 3
NCT00194324 COMPLETED
Health; Vulvovaginal Candidiasis
University of Pennsylvania
 2004-07 PHASE4
NCT00004575 COMPLETED
Healthy
National Heart, Lung, and Blood Institute (NHLBI)
 2000-02 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-12-31)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Miconazole nitrate directly binds to cytochrome P450 14-alpha demethylase, inhibiting the enzyme-mediated conversion of lanosterol to ergosterol and suppressing crucial fungal membrane synthesis. This disruption of ergosterol biosynthesis severely impairs fungal cell membrane integrity and increases cellular permeability, driving the clinical resolution of fungal infections such as vaginal candidiasis and otomycosis.

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>).

Jump to

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