Clinical Trials

Several clinical trials investigate conditions including chronic rhinosinusitis, pelvic floor disorders with vaginal atrophy, systemic scleroderma, organ transplantation, and renal transplant rejection involving fibrosis and graft loss. Conducted by academic and medical institutions such as Leiden University Medical Center, Beijing Tongren Hospital, University Hospital Lille, and the Institute for the Care of Mother and Child in Prague, these protocols encompass Phase 1, Phase 2, combined Phase 1/2, and non-interventional or non-applicable phases. Across these studies, recruitment statuses vary from recruiting and active not recruiting to completed or unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05428410 Unknown status
Chronic Rhino-sinusitis|IL-4R|Monoclonal Antibody|Biomarker
Beijing Tongren Hospital
 2022-06-17 --
NCT05898191 Active not recruiting
Pelvic Floor Disorders|Vaginal Atrophy
Institute for the Care of Mother and Child Prague Czech Republic|Department of Obstetrics and Gynecology Faculty of Medicine CUNI Pilsen Czechia|NTIS Faculty of Applied Sciences University of West Bohemia Pilsen Czechia
 2019-02-01 Not Applicable
NCT03559465 Recruiting
Scleroderma Systemic
University Hospital Lille
 2018-10-29 Not Applicable
NCT02387151 Completed
Rejection|Graft Loss
Leiden University Medical Center
 2015-03 Phase 1
NCT02057965 Unknown status
Renal Transplant Rejection|Fibrosis
Leiden University Medical Center
 2014-03 Phase 2
NCT00734396 Completed
Organ Transplantation
Leiden University Medical Center
 2009-02 Phase 1|Phase 2

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

Check the DIRECT RED 80 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Direct Red 80, a polyazo dye, selectively binds to basic amino acid residues along collagen molecules via its sulfonic acid groups, thereby enhancing collagen birefringence and enabling precise histological quantification of extracellular matrix fibers. This molecular interaction prevents non-specific background staining to yield specific visualization of tissue architecture, providing critical diagnostic utility for evaluating fibrotic remodeling in conditions such as systemic scleroderma and renal transplant rejection.

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>).

Jump to

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