Clinical Trials

A completed Phase 4 clinical trial sponsored by Allerderm evaluated diazolidinyl urea within a specialized patch test panel for diagnosing contact dermatitis in children and adolescents. The study focused on characterizing cutaneous hypersensitivity reactions and allergen reactivity associated with cosmetic preservative exposure. Overall, this trial underscores the utility of diazolidinyl urea as a diagnostic allergen for evaluating contact allergy and dermatological sensitivity.

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 Diazolidinyl urea product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diazolidinyl urea functions as a formaldehyde-releasing preservative that alkylates microbial cellular nucleophiles, thereby disrupting essential enzymatic and nucleic acid processes to inhibit microbial cell proliferation. In dermatological contexts, hapten formation from released formaldehyde can induce delayed-type hypersensitivity responses, providing the mechanistic basis for its clinical use in diagnostic patch testing for 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>).

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