Clinical Trials

Multiple clinical trials have evaluated parthenolide for dermatological indications, specifically contact dermatitis and allergic contact dermatitis. This research pipeline includes a Phase 2 trial sponsored by Mekos Laboratories AS and a Phase 3 trial sponsored by Allerderm, both of which have completed recruitment. These studies investigated the inclusion of parthenolide within standardized allergen panel testing protocols to evaluate skin hypersensitivity reactions in clinical diagnostic settings.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00640614 COMPLETED
Contact Dermatitis
Allerderm
 2008-04 PHASE3
NCT00133341 COMPLETED
Allergic Contact Dermatitis
Mekos Laboratories AS
 2005-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2020-05-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

(-)-Parthenolide inhibits the nuclear factor-κB (NF-κB) signaling pathway and selectively depletes histone deacetylase 1 (HDAC1), which downregulates pro-inflammatory gene expression, promotes MDM2 ubiquitination, and activates p53-dependent cellular responses. This suppression of inflammatory mediator cascades and immune activation provides the mechanistic foundation for its clinical study in contact dermatitis and allergic 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.