Clinical Trials

Numerous clinical trials evaluate epigallocatechin and related green tea polyphenols across diverse dermatological, neurodegenerative, and oncological conditions, including acne vulgaris, radiation dermatitis, small cell lung carcinoma, Alzheimer's disease, traumatic brain injury, frailty, and systemic inflammation. Spanning Early Phase 1 through Phase 4, these investigations are sponsored by academic institutions and medical centers, such as Seoul National University Hospital, Charité University, and the University of Rochester. Current recruitment statuses across the dataset encompass completed, recruiting, and suspended studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06068543 SUSPENDED
Frailty; Inflammation
University of Rochester
2024-10-25 PHASE2
NCT06015022 RECRUITING
Cirrhosis, Liver
University of Texas Southwestern Medical Center
2024-09-01 PHASE2
NCT07697196 NOT_YET_RECRUITING
HPV Infection; HPV Integration; HPV Disease; HPV Genital Infection; HPV Persistence; Low Grade Squamous Intraepithelial Lesions of the Cervix
IRCCS San Raffaele
2026-07
NCT07149506 ENROLLING_BY_INVITATION
Radiation Dermatitis Acute; Radiation Dermatitis; Fibrosis; Skin
CARLOS FRANCISCO SAAVEDRA GARCIA
2025-09-01 PHASE3
NCT05364008 ACTIVE_NOT_RECRUITING
Leiomyoma, Uterine
Yale University
2023-01-05 PHASE3
NCT05409872 COMPLETED
Leiomyoma, Uterine
Universita di Verona
2022-09-15
NCT06398405 UNKNOWN
Esophageal Cancer; Dysphagia, Esophageal; Epigallocatechin Gallate
Shandong Cancer Hospital and Institute
2024-04-22 PHASE2
NCT05195918 COMPLETED
Idiopathic Pulmonary Fibrosis
Hal Chapman
2023-08-24 PHASE1
NCT07725900 COMPLETED
Hyperpigmentation; Dry Skin; Erythema
Naniek Widyaningrum
2025-12-01 PHASE2; PHASE3
NCT05448365 RECRUITING
Uterine Fibroids; D-chiro-inositol; Inositol; Epigallocatechin Gallate; Vitamin D; Vitamin B6
Lo.Li.Pharma s.r.l
2022-07-01
NCT06285357 RECRUITING
HPV Infection
Lo.Li.Pharma s.r.l
2024-02-19
NCT05811403 COMPLETED
Irreversible Pulpitis
Cairo University
2023-07-01
NCT06531863 RECRUITING
Mood Disturbance
Auburn University
2024-09-30 EARLY_PHASE1
NCT06524609 UNKNOWN
Chemotherapy-induced Peripheral Neuropathy
Han Xi Zhao
2023-11-30 PHASE1; PHASE2
NCT05988788 COMPLETED
Necrotic Pulp
Cairo University
2023-10-01
NCT02891538 COMPLETED
Colon Cancer
The University of Texas Health Science Center at San Antonio
2017-01-31 EARLY_PHASE1
NCT04553666 COMPLETED
Frailty; Inflammation
University of Rochester
2021-04-28 PHASE2
NCT01744587 COMPLETED
NPC
National Health Research Institutes, Taiwan
2013-04
NCT05625308 COMPLETED
Papilloma; Cervix Lesion
Lo.Li.Pharma s.r.l
2022-07-01
NCT05116098 UNKNOWN
Tuberculosis
Ministry of Health, Saudi Arabia
2021-11-30 PHASE1
NCT02577393 UNKNOWN
Lung Neoplasms; Esophagitis; Prevention & Control; Epigallocatechin Gallate
Shandong Cancer Hospital and Institute
2015-04 PHASE2
NCT05349903 COMPLETED
Appetitive Behavior; Obesity; Diabetes Mellitus, Type 2
Purdue University
2021-11-10
NCT04177693 COMPLETED
Uterine Fibroids
Yale University
2020-11-24 PHASE1
NCT03883880 TERMINATED
Diet, Food Choice, Taste
Purdue University
2019-01-05
NCT02887950 TERMINATED
Overweight
Fondazione IRCCS Policlinico San Matteo di Pavia
2016-09
NCT02580279 UNKNOWN
Breast Neoplasms; Dermatitis; Prevention & Control; Epigallocatechin Gallate
Shandong Cancer Hospital and Institute
2014-12 PHASE2
NCT03928847 COMPLETED
Idiopathic Pulmonary Fibrosis
Hal Chapman
2017-12-01 EARLY_PHASE1
NCT03740295 COMPLETED
Multiple Sclerosis
Fundación Universidad Católica de Valencia San Vicente Mártir
2018-10-05 PHASE2
NCT01183767 COMPLETED
Duchenne Muscular Dystrophy
Charite University, Berlin, Germany
2010-12-30 PHASE2; PHASE3
NCT02015312 COMPLETED
Light Chain (AL) Amyloidosis; Cardiac Involvement
Florian Michel
2013-04 PHASE2
NCT03194620 COMPLETED
Healthy
University of California, Davis
2016-08
NCT02558933 COMPLETED
Fetal Alcohol Syndrome (FAS)
Fundacion Clinic per a la Recerca Biomédica
2016-03
NCT01511263 TERMINATED
Primary Amyloidosis of Light Chain Type
Fondazione IRCCS Policlinico San Matteo di Pavia
2012-01 PHASE2
NCT00799890 COMPLETED
Multiple Sclerosis
Friedemann Paul
2009-05 PHASE2; PHASE3
NCT03199430 COMPLETED
EGCG Influence on Catecholamine Metabolism
Swansea University
2015-09 PHASE4
NCT00434499 WITHDRAWN
Hypertension; Obesity; Type 2 Diabetes; Insulin Resistance
University of Maryland, Baltimore
2007-02 PHASE2
NCT02731495 COMPLETED
Traumatic Brain Injury
National Nutrition and Food Technology Institute
2015-03 PHASE2; PHASE3
NCT01357681 COMPLETED
Huntington Disease
Charite University, Berlin, Germany
2011-09 PHASE2
NCT00951834 COMPLETED
Alzheimer's Disease
Charite University, Berlin, Germany
2009-10 PHASE2; PHASE3
NCT02147041 UNKNOWN
Diabetes Mellitus; Hyperlipidemia
Taipei City Hospital
2012-05 PHASE2; PHASE3
NCT01699711 COMPLETED
Down Syndrome (DS)
Parc de Salut Mar
2012-02 PHASE2
NCT00951964 COMPLETED
Epidermolysis Bullosa Dystrophica
Centre Hospitalier Universitaire de Nice
2010-10 PHASE2
NCT00525668 COMPLETED
Relapsing-remitting Multiple Sclerosis
Charite University, Berlin, Germany
2007-09 PHASE1; PHASE2
NCT01394796 COMPLETED
Down Syndrome
Parc de Salut Mar
2010-05 PHASE2
NCT00981292 COMPLETED
Cognitive Function; Mood
Northumbria University
2009-08 PHASE4
NCT01687556 COMPLETED
Acne Vulgaris
Seoul National University Hospital
2005-07
NCT00153790 COMPLETED
Weight Loss
The Cooper Institute
2005-04 PHASE1
NCT00476138 UNKNOWN
Primary Open Angle Glaucoma; Ocular Hypertension
Catholic University of the Sacred Heart
2006-11 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

(-)-Epigallocatechin binds key cellular targets and modulates oxidative stress pathways, thereby blocking downstream pro-inflammatory kinase signaling and oncogenic transcription factors. This inhibition reduces cellular proliferation and inflammatory output, providing a mechanistic basis for its clinical investigation in conditions such as acne vulgaris, radiation dermatitis, small cell lung carcinoma, and chronic inflammation.

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>).

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