Halobetasol Propionate Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple open-label, multicenter Phase 4 clinical trials sponsored by Bausch Health Americas Inc. are actively recruiting patients to evaluate topical halobetasol propionate for psoriasis management. These studies primarily assess systemic pharmacokinetics, cutaneous absorption, and hypothalamic-pituitary-adrenal axis suppression following topical application. Ultimately, these late-phase investigations aim to characterize the safety and systemic exposure profile of the treatment in patients with psoriasis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03988439	Recruiting	Psoriasis	Bausch Health Americas Inc.	2021-03-24	Phase 4
NCT03987763	Recruiting	Psoriasis	Bausch Health Americas Inc.	2019-10-22	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Halobetasol propionate binds to cytoplasmic glucocorticoid receptors, inducing nuclear translocation and modulating gene transcription to inhibit pro-inflammatory mediator production and downstream cytokine signaling. This molecular suppression leads to reduced leukocyte activation, diminished cellular inflammation, and decreased keratinocyte hyperproliferation, ultimately mitigating the inflammatory cutaneous manifestations observed in clinical trials for psoriasis.

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>).