Clinical Trials

Numerous clinical trials across various phases have evaluated bacitracin for skin infections, burns, contact dermatitis, paranasal sinus disease, acne, and viral coinfections such as herpes simplex. Led by academic medical centers, health systems, and government organizations—including MetroHealth Medical Center, Henry Ford Health System, and the National Institute of Allergy and Infectious Diseases—these registered protocols display varied recruitment statuses, including completed, pending, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07549828 NOT_YET_RECRUITING
Acne; Atopic Dermatitis; Seborrheic Dermatitis; Psoriasis; Healthy Subjects (HS)
National Taiwan University Hospital
 2026-04-01
NCT07698938 COMPLETED
Teste the Safety of (Polymyxin B Sulfate 500,000 IU, Bacitracin Zinc 40,000 IU, Neomycin Sulfate 0.35g Neomycin Base) Intranasally
Hospital Universitario Dr. Jose E. Gonzalez
 2025-02-13
NCT04880655 COMPLETED
Burns; Partial-thickness Burn
University of Tennessee
 2021-08-03
NCT05874219 COMPLETED
Hemodialysis Complication; Hemodialysis Catheter Infection
Future University in Egypt
 2023-04-10 PHASE2; PHASE3
NCT02809131 COMPLETED
Sick Sinus Syndrome; Complete Heart Block; Syncope; Chronic Systolic Heart Failure
Vanderbilt University Medical Center
 2016-04-01 PHASE3
NCT03929224 COMPLETED
Skin Infection
Henry Ford Health System
 2018-10-25 PHASE4
NCT02673229 TERMINATED
Burn, Partial Thickness
University of Kansas Medical Center
 2013-09-30 PHASE4
NCT03213249 COMPLETED
Breast Implant Infection; Mammoplasty
Washington University School of Medicine
 2017-07-25 PHASE1
NCT02106962 COMPLETED
Arteriovenous Fistula
California Institute of Renal Research
 2014-04 PHASE4
NCT01350102 TERMINATED
Diabetes, Type 1; Diabetes, Type 2; Foot Ulcer, Diabetic
Susan Hassenbein
 2012-02 PHASE4
NCT01668030 COMPLETED
Burns
University of Louisville
 2012-02 PHASE4
NCT01516463 WITHDRAWN
Burn, Partial Thickness
Healthpoint
 2012-03 PHASE4
NCT01222832 COMPLETED
Paranasal Sinus Disease
Steward St. Elizabeth's Medical Center of Boston, Inc.
 2010-07 PHASE2
NCT00671541 WITHDRAWN
Chronic Sinusitis
Lahey Clinic
 2006-03 PHASE4
NCT01002911 COMPLETED
Arrythmias
Population Health Research Institute
 2009-12 PHASE3
NCT01359735 COMPLETED
Non-melanoma Skin Cancer
Healthpoint
 2011-05 PHASE2
NCT00997139 COMPLETED
Nasal Carriers of Staphylococcus Aureus
Northwestern University
 2009-09
NCT00705354 WITHDRAWN
Sinusitis; Chronic Sinusitis
Lahey Clinic
 2009-01
NCT00640614 COMPLETED
Contact Dermatitis
Allerderm
 2008-04 PHASE3
NCT00479193 WITHDRAWN
Burns
MetroHealth Medical Center
 2006-10 PHASE1
NCT00674999 WITHDRAWN
Burn
The University of Texas Medical Branch, Galveston
 2005-06 PHASE2; PHASE3
NCT00000635 COMPLETED
Herpes Simplex; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00132600 COMPLETED
Allergic Contact Dermatitis
Mekos Laboratories AS
 2005-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bacitracin binds to C55-isoprenyl pyrophosphate, inhibiting the dephosphorylation step required to regenerate the lipid carrier necessary for peptidoglycan cell wall biosynthesis in susceptible bacteria. This disruption destabilizes bacterial cell wall integrity, leading to osmotic lysis and cell death, which underlies its therapeutic efficacy in treating localized skin infections, burns, and dermatological conditions investigated 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.