Clindamycin Phosphate Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several clinical trials evaluate clindamycin phosphate across dermatological and infectious conditions. Completed research includes a Phase II study by the Jinnah Postgraduate Medical Centre investigating topical clindamycin phosphate gel for moderate acne vulgaris, alongside an Alexandria University drug evaluation on critical care bacterial infections. Additionally, a trial sponsored by University Hospital Brest with an unknown recruitment status assesses the drug in staphylococcal prosthetic joint infections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05926869	Completed	Acne Vulgaris	Jinnah Postgraduate Medical Centre	2022-08-01	Phase 2
NCT05223400	Completed	Infection Bacterial	Alexandria University	2022-03-01	--
NCT04946500	Unknown status	Prosthetic Joint Infection\|Staphylococcus	University Hospital Brest	2021-05-15	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clindamycin phosphate reversibly binds to the 50S ribosomal subunit of susceptible microorganisms, thereby inhibiting peptidyl transferase activity and blocking nascent polypeptide chain elongation during protein synthesis. This disruption of vital cellular translation suppresses pathogen proliferation and microbial protein production, providing the therapeutic basis for treating clinical conditions such as acne vulgaris and staphylococcal infections.

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>).