Oxytetracycline (Terramycin) Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

A clinical trial evaluated the therapeutic efficacy and tolerability of oxytetracycline in human subjects presenting with specific dermatological infections, including degree II or III acne vulgaris and boils. Sponsored by Laboratorios Goulart S.A., this prospective, randomized, open multicenter Phase 3 study aimed to assess comparative clinical outcomes in managing these bacterial skin disorders. Currently, the recruitment status of this trial is categorized as unknown in registry records.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01032499	Unknown status	Acne Vulgaris II or III Degree\|Boils	Laboratorios Goulart S.A.	2010-05	Phase 3

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

Check the Oxytetracycline (Terramycin) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxytetracycline reversibly binds to the 30S ribosomal subunit of susceptible bacteria, preventing aminoacyl-tRNA binding to the acceptor site and inhibiting essential protein synthesis. Consequently, this suppression of protein translation halts bacterial multiplication and growth, providing therapeutic clinical activity in the management of bacterial skin infections such as acne vulgaris and boils.

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>).