Multiple clinical trials have evaluated salicylic acid across Phase I, Phase IV, and non-phase study designs for conditions such as acne vulgaris and cardiovascular disease, alongside pharmacokinetic evaluations in healthy volunteers. Characterized by completed or unknown recruitment statuses, these investigations focused on topical peels for acne and novel formulation pharmacodynamics. Sponsoring organizations include Combined Military Hospital Abbottabad, Rhoshan Pharmaceuticals Inc, PLx Pharma, and Vita Green Health Products Co. Ltd.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05712837 | Completed | Acne Vulgaris |
Combined Military Hospital Abbottabad |
2022-06-01 | Not Applicable |
| NCT05166096 | Completed | Healthy |
Rhoshan Pharmaceuticals Inc |
2021-12-03 | Phase 1 |
| NCT04811625 | Completed | Healthy Volunteers |
PLx Pharma |
2021-04-28 | Phase 4 |
| NCT04792723 | Unknown status | Cardiovascular Diseases |
Vita Green Health Products Co. Ltd |
2021-03-05 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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>).