Clinical Trials

Several clinical trials evaluate the diagnostic and therapeutic utility of agar-based assays and natural products across dermatological and infectious conditions, including dermatophytoses, Escherichia coli infections, and nosocomial bacterial pathogens. Conducted primarily by academic sponsors such as the University of Extremadura, Suez Canal University, and Sohag University, the portfolio spans Phase 3 testing alongside observational and non-applicable interventional designs. Featuring recruitment statuses ranging from completed to unknown, these studies assess interventions including essential oils, bacterial biofilm formation, and metallic nanoparticles.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05777525 Completed
Dermatophytoses|Skin Lesion
University of Extremadura
 2023-02-11 Phase 3
NCT06252428 Completed
Escherichia Coli Infections
Suez Canal University
 2022-12-20 --
NCT04775238 Unknown status
Nosocomial Infections
Sohag University
 2021-02-27 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Agar is composed of linear agarose and branched agaropectin polysaccharides that cross-link via non-covalent hydrogen bonding to form a semi-solid polymer hydrogel, which physically encapsulates moisture and nutrients while remaining resistant to enzymatic degradation by most microbial pathogens. This structural matrix provides an essential substrate for culturing, isolating, and identifying infectious microorganisms, facilitating the diagnostic evaluation of dermatophytoses, uropathogenic Escherichia coli infections, and hospital-acquired bacterial pathogens in clinical settings.

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.