Imidazolidinyl Urea Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A completed Phase 4 clinical trial, sponsored by Allerderm, evaluated the use of imidazolidinyl urea in diagnosing contact dermatitis. The study assessed the clinical performance and diagnostic applicability of a multi-allergen patch test panel containing this antimicrobial preservative in pediatric and adolescent patients. Overall, the findings support the utility of imidazolidinyl urea within standardized patch testing protocols to identify contact sensitivity and allergic reactions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00795951	Completed	Dermatitis Contact	Allerderm	2008-11	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Imidazolidinyl urea acts as an antimicrobial formaldehyde-releasing agent that penetrates microbial cell walls and cross-links cellular proteins and nucleic acids, thereby inhibiting essential enzymatic pathways and disrupting cellular integrity. This cascade suppresses bacterial and fungal proliferation to prevent microbial contamination, providing the rationale for its clinical use in diagnostic patch testing to evaluate patients with contact dermatitis.

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>).