Etretinate Clinical Trials

Size	Price	Qty
20mg	USD 97

Clinical Trials

Multiple clinical trials evaluate this compound's efficacy in treating dermatological pathologies (acne and acne vulgaris), periodontal diseases (periodontitis and periimplantitis), and psychiatric indications such as resistant depression. Spanning Phase 1 through Phase 4 alongside unlisted phase designations, these studies are led by academic sponsors including the University of Pennsylvania, Tokat Gaziosmanpasa University, Centre Hospitalier Universitaire de Besancon, and the University of California, Davis. Operational recruitment statuses across these trials currently encompass recruiting, completed, and unknown states.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04582383	Recruiting	Acne	University of Pennsylvania	2022-03-30	Phase 4
NCT04018144	Unknown status	Periodontitis	Tokat Gaziosmanpasa University	2019-08-01	--
NCT04020146	Completed	Periodontitis\|Periimplantitis	Tokat Gaziosmanpasa University	2018-01-10	--
NCT02847533	Unknown status	Depression	Centre Hospitalier Universitaire de Besancon	2016-09	Not Applicable
NCT02620813	Completed	Acne Vulgaris	University of California Davis	2015-10	Early Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Etretinate binds to and activates nuclear retinoid receptors, which subsequently alters gene transcription to induce cellular differentiation, suppress cell proliferation, and inhibit tissue infiltration by inflammatory cells. This suppression of hyperproliferation and inflammatory cellular recruitment directly underlines its therapeutic relevance in managing dermatological disorders like acne vulgaris and inflammatory tissue pathologies such as periodontitis.

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>).