Clinical Trials

Clotrimazole has been evaluated in numerous clinical trials spanning early Phase 1 through Phase 4 for a wide range of indications, primarily fungal infections—such as vulvovaginal candidiasis, oropharyngeal candidiasis, and dermatophytoses—as well as exploratory applications in inflammatory bowel disease and HIV prevention. Conducted by academic institutions, government bodies, and pharmaceutical sponsors, these studies encompass various recruitment statuses, including completed, active, terminated, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06349122 NOT_YET_RECRUITING
Bacterial Vaginosis; Vaginal Dysbiosis; Premature Delivery
Assistance Publique Hopitaux De Marseille
 2026-10 PHASE3
NCT07331792 NOT_YET_RECRUITING
Pityriasis Versicolor
Combined Military Hospital Abbottabad
 2026-02-02 PHASE1; PHASE2
NCT07535424 COMPLETED
Otomycosis
Mayo Hospital Lahore
 2024-11-20
NCT07441005 COMPLETED
Tinea Cruris
Hayat Abad Medical Complex, Peshawar
 2025-05-15 EARLY_PHASE1
NCT06835361 RECRUITING
Candidal Vulvovaginitis (ICD-10 Code: B37.3); Vulvovaginal Candidiasis (VVC)
AVVA Pharmaceuticals Ltd.
 2024-02-29 PHASE2; PHASE3
NCT07718685 COMPLETED
Dermatophytoses
Shalamar Institute of Health Sciences
 2025-01-01
NCT06869681 NOT_YET_RECRUITING
Tinea Pedis
Jinnah Postgraduate Medical Centre
 2025-03-01 PHASE4
NCT04699240 COMPLETED
Recurrent Vulvovaginal Candidiasis
Peking University Shenzhen Hospital
 2020-07-01 PHASE4
NCT06339294 COMPLETED
Otomycosis
Rawalpindi Medical College
 2023-06-16 PHASE1
NCT07727967 COMPLETED
Vulvovaginal Candidiasis
BioGrowing Co., Ltd
 2022-07-01
NCT04824261 UNKNOWN
Otomycosis
Assiut University
 2021-06-01
NCT04292704 UNKNOWN
Vulvovaginal Candidiasis, Genital; Laser Therapy
Second Affiliated Hospital of Wenzhou Medical University
 2019-12-13
NCT00061282 TERMINATED
Ulcerative Colitis; Pouchitis; Ileitis; Inflammatory Bowel Disease
Web
 2002-09-30 PHASE1; PHASE2
NCT02582177 COMPLETED
Tinea
Ache Laboratorios Farmaceuticos S.A.
 2019-06-11 PHASE3
NCT03024502 UNKNOWN
Vulvovaginal Candidiasis
University of Sao Paulo
 2018-01-30 PHASE1; PHASE2
NCT02907307 WITHDRAWN
Vulvovaginal Candidiasis
Medinova AG
 2018-12 PHASE3
NCT03005353 COMPLETED
Infection, Fungal
Assiut University
 2018-03-01 PHASE2; PHASE3
NCT03632733 UNKNOWN
Keratotic Nodular Size
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2018-01-21 PHASE2
NCT02635438 UNKNOWN
Oropharyngeal Candidiasis
Thinq Pharma-CRO Pte. Ltd.
 2016-12 PHASE3
NCT03115073 COMPLETED
Vulvovaginal Candidiasis (VVC)
ProFem GmbH
 2017-04-04 PHASE2; PHASE3
NCT03026478 UNKNOWN
Oral Lichen Planus
Garlapati Komali
 2016-05-06 PHASE2
NCT02860845 COMPLETED
Candidiasis; Vaginosis, Bacterial
Laboratorios Ordesa
 2016-07-12 PHASE4
NCT02847286 COMPLETED
HIV- Prevention
International Partnership for Microbicides, Inc.
 2015-09-01 PHASE1
NCT02242695 COMPLETED
Vulvovaginal Candidiasis
Medinova AG
 2014-11 PHASE4
NCT02180828 COMPLETED
Candidiasis, Vulvovaginal
Peking University Shenzhen Hospital
 2014-07 PHASE4
NCT01547221 COMPLETED
Otomycosis
Khon Kaen Hospital
 2012-03
NCT02248506 COMPLETED
Candidiasis, Vulvovaginal
Instituto Palacios
 2013-06 PHASE4
NCT01993823 COMPLETED
Otomycosis
Salvat
 2013-05 PHASE3
NCT02713139 WITHDRAWN
Sexual Active Women; Vaginal Discharge
Ache Laboratorios Farmaceuticos S.A.
 2013-09 PHASE3
NCT01105013 UNKNOWN
Fungal Infections; Tinea Pedis; Tinea Cruris; Tinea Corporis
Laboratório Teuto Brasileiro S/A
 2012-04 PHASE3
NCT01524432 COMPLETED
Tinea Pedis
Prof. Yuen Chun-Wah
 2012-01 PHASE1
NCT00835029 COMPLETED
Oral Candidiasis; Denture Stomatitis
Hadassah Medical Organization
 2009-03 PHASE2
NCT01697826 COMPLETED
Vaginal Infections
Dr Bharti Daswani
 2011-04 PHASE4
NCT00671528 TERMINATED
Dermatitis, Atopic; Eczema, Atopic; Skin Diseases, Eczematous
Organon and Co
 2009-07 PHASE4
NCT00078559 COMPLETED
Kidney Transplantation; Kidney Disease
University of Wisconsin, Madison
 2003-11 PHASE1; PHASE2
NCT00629122 COMPLETED
Kidney Failure, Chronic
Weill Medical College of Cornell University
 2008-02 PHASE4
NCT00755053 COMPLETED
Clotrimazole; Ovulen; Vulvovaginal Candidiasis
Bayer
 2008-09 PHASE3
NCT00390780 COMPLETED
HIV Infections
Valerio Therapeutics
 2006-07 PHASE3
NCT01244256 SUSPENDED
Folliculitis
Azidus Brasil
 2007-04 PHASE2; PHASE3
NCT02184351 COMPLETED
Candidiasis, Oral
Boehringer Ingelheim
 2001-05 PHASE3
NCT00000676 COMPLETED
Candidiasis; Mycoses; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00004404 COMPLETED
Sickle Cell Anemia
Boston Children's Hospital
 1997-04
NCT00313131 COMPLETED
Bacterial Vaginosis; Candidiasis; Vaginitis
Université de Sherbrooke
 2004-01 PHASE3
NCT00002282 COMPLETED
Candidiasis, Oral; HIV Infections
Pfizer
NCT00004492 COMPLETED
Sickle Cell Anemia
University of North Carolina
 1999-10 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-27)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clotrimazole alters fungal cell wall structure by inhibiting ergosterol biosynthesis, which compromises cell membrane integrity and leads to the loss of essential intracellular contents and cell lysis. By directly impairing fungal membrane stability and cellular viability, this mechanism drives the therapeutic efficacy of clotrimazole in clinical trial indications such as vulvovaginal candidiasis, oropharyngeal candidiasis, and dermatophytoses.

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.