Perillyl alcohol Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial investigated the therapeutic potential of topical perillyl alcohol for precancerous conditions associated with sun-damaged skin. Sponsored by the University of Arizona in collaboration with the National Cancer Institute and the Arizona Disease Control Research Commission, this completed Phase 2, randomized, placebo-controlled study evaluated dermatological lesion prevention. Overall, clinical evaluation of the monoterpene remains focused on early-phase interventions for actinic skin changes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00608634	Completed	Precancerous Condition	University of Arizona\|National Cancer Institute (NCI)\|Arizona Disease Control Research Commission	2004-05	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Perillyl alcohol inhibits protein prenylation enzymes, including farnesyltransferase, thereby disrupting downstream Ras oncogenic signaling pathways and arresting cell cycle progression. This biochemical blockade suppresses cellular proliferation and promotes apoptosis, which inhibits the growth and maturation of dysplastic cells in precancerous skin conditions.

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>).