Clinical Trials

A clinical trial sponsored by the academic institution University of California, Davis evaluated the photobiological effects of avobenzone on cutaneous oxidative stress mechanisms in individuals with sun-damaged skin. Designated with a phase status of Not Applicable, the completed study quantified singlet oxygen generation following exposure to ultraviolet A radiation. These findings provide targeted insights into how avobenzone mitigates solar radiation-induced photo-oxidative stress in dermatological settings.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05865431 Completed
Sun Damaged Skin
University of California Davis
2017-03-17 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Avobenzone is a dibenzoylmethane filter that absorbs broad-spectrum ultraviolet A radiation, dissipating absorbed photon energy through photophysical relaxation pathways. By preventing radiation-induced cellular photo-excitation and subsequent singlet oxygen generation, this compound protects cutaneous structures from photo-oxidative damage, demonstrating direct therapeutic relevance for sun-damaged skin.

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>).

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