Clinical Trials

A clinical trial sponsored by Laboratorios Goulart S.A. evaluated the therapeutic application of a topical oxytetracycline dihydrate formulation for dermatological inflammatory conditions, specifically acne vulgaris and boils. This prospective, randomized, open-label late-stage study focused on assessing drug efficacy and tolerability in clinical settings, though its recruitment status is currently reported as unknown. Overall, clinical development for this agent remains directed at dermatological bacterial infections.

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 Dihydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxytetracycline dihydrate reversibly binds to the 30S ribosomal subunit in susceptible bacteria, blocking aminoacyl-tRNA binding to the ribosomal acceptor site and halting essential protein synthesis. This inhibition of translation suppresses bacterial growth and survival, providing the mechanistic basis for treating dermatological bacterial conditions including 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>).

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Note: Technical data last updated: Sep 1, 2026.