Clinical Trials

Multiple clinical trials have evaluated the therapeutic application of Licochalcone A, primarily focusing on dermatological and oncological conditions such as acne vulgaris and squamous cell carcinoma. Ranging from Phase 1 and Phase 3 evaluations to unassigned phase classifications, these completed studies investigated topical regimens and adjunctive chemotherapy protocols. Sponsorship for these investigations was provided by academic and corporate entities, including Mahidol University, Cairo University, and Beiersdorf.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03292822 COMPLETED
Squamous Cell Carcinoma
Cairo University
2021-02-15 PHASE1
NCT04002024 COMPLETED
Acne Vulgaris; Acne
Mahidol University
2019-06-01
NCT04002024 Completed
Acne Vulgaris|Acne
Mahidol University|Beiersdorf
2019-06-01 Not Applicable
NCT02173054 COMPLETED
Acne
Mahidol University
2014-07 PHASE3

(data from https://clinicaltrials.gov, updated on 2024-06-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Licochalcone A selectively modulates estrogenic receptors and inflammatory pathways, suppressing downstream pro-inflammatory cytokine secretion and oncogenic signal transduction. This targeted biochemical inhibition reduces cellular proliferation and mitigates localized tissue inflammation, demonstrating therapeutic potential in clinical applications targeting acne vulgaris and squamous cell carcinoma.

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.