Betamethasone Dipropionate Clinical Trials

Size	Price	Qty
500mg	USD 97
1g	USD 129

Clinical Trials

Several clinical trials spanning Phase 1 through Phase 3 have evaluated betamethasone dipropionate, focusing on inflammatory dermatological conditions such as psoriasis and psoriasis vulgaris, as well as pharmacokinetic assessments in healthy volunteers. Sponsored by pharmaceutical companies including LEO Pharma and MC2 Therapeutics, all recorded trials have completed recruitment. Collectively, these studies demonstrate a structured effort to optimize topical formulations and therapeutic efficacy for inflammatory skin diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03476746	Completed	Healthy	LEO Pharma	2018-03-20	Phase 1
NCT03462927	Completed	Psoriasis Vulgaris	MC2 Therapeutics	2018-02-08	Phase 2
NCT02605057	Completed	Psoriasis Vulgaris	LEO Pharma	2015-11	Phase 1
NCT01768013	Completed	Psoriasis Vulgaris	LEO Pharma	2012-07	Phase 1\|Phase 2
NCT00279162	Completed	Psoriasis	LEO Pharma	2005-12	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Betamethasone dipropionate functions as a synthetic glucocorticoid receptor agonist that binds intracellular steroid receptors, inducing nuclear translocation to suppress pro-inflammatory transcription factors and inhibit downstream cytokine production. This molecular inhibition attenuates immune cell activation, vascular permeability, and local mediator release. Consequently, this potent immunosuppressive and anti-inflammatory activity provides the clinical rationale for suppressing plaque formation and epidermal inflammation in psoriasis vulgaris.

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>).