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.
Mechanism and Biochemical Profile
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.