Sinecatechins
- Generic Name
- Sinecatechins
- Brand Names
- Veregen
- Drug Type
- Small Molecule
- CAS Number
- 188265-33-0
- Unique Ingredient Identifier
- T432289GYZ
- Background
Sinecatechins is a botanical drug product for topical use. It is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg) and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.
- Indication
For the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
- Associated Conditions
- Condylomata Acuminata, Perianal Warts
To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring
- Conditions
- Prostate Carcinoma
- Interventions
- Other: Quality-of-Life AssessmentDrug: Placebo AdministrationOther: Questionnaire Administration
- First Posted Date
- 2020-10-22
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- Target Recruit Count
- 360
- Registration Number
- NCT04597359
- Locations
- 🇺🇸
Bethesda North Hospital, Cincinnati, Ohio, United States
🇺🇸Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
🇺🇸Cheyenne Regional Medical Center-West, Cheyenne, Wyoming, United States
Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males
- Conditions
- High-grade Anal Intraepithelial Neoplasia
- Interventions
- Procedure: electrocoagulation
- First Posted Date
- 2019-08-13
- Last Posted Date
- 2024-07-10
- Target Recruit Count
- 108
- Registration Number
- NCT04055142
- Locations
- 🇪🇸
Hospital U. Vall d'Hebrón, Barcelona, Catalunya, Spain
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
- Conditions
- Vulvovaginal AtrophyGenito-Pelvic Pain/Penetration DisorderPostmenopausal SymptomsFemale Sexual DysfunctionVestibulodyniaSexual Pain DisordersVulvodyniaArousal Disorders, SexualDyspareuniaFemale Sexual Arousal Disorder
- Interventions
- First Posted Date
- 2018-09-24
- Last Posted Date
- 2022-07-27
- Lead Sponsor
- GTO Pharmaceutical, LLC
- Target Recruit Count
- 32
- Registration Number
- NCT03682601
- Locations
- 🇺🇸
Lila Nachtigall, M.D., New York, New York, United States
🇺🇸Cynthia Krause, M.D., New York, New York, United States
🇺🇸Janis Enzenbacher, M.D., Nyack, New York, United States
Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study
- Conditions
- Verruca, Warts
- Interventions
- Procedure: Cryotherapy and Veregen
- First Posted Date
- 2015-12-04
- Last Posted Date
- 2017-09-08
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Target Recruit Count
- 28
- Registration Number
- NCT02622568
- Locations
- 🇺🇸
UTSW Department of Dermatology, Dallas, Texas, United States
Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment
- Conditions
- External Genital Warts
- Interventions
- Drug: Cryotherapy alone
- First Posted Date
- 2014-05-26
- Last Posted Date
- 2019-06-14
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Target Recruit Count
- 42
- Registration Number
- NCT02147353
- Locations
- 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Topical Green Tea Ointment in Treatment of Superficial Skin Cancer
- First Posted Date
- 2014-01-07
- Last Posted Date
- 2016-05-18
- Lead Sponsor
- Maastricht University Medical Center
- Target Recruit Count
- 42
- Registration Number
- NCT02029352
- Locations
- 🇳🇱
Maastricht University Medical Centre, Maastricht, Limburg, Netherlands
Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers
- First Posted Date
- 2011-12-12
- Last Posted Date
- 2012-04-19
- Lead Sponsor
- MediGene
- Target Recruit Count
- 30
- Registration Number
- NCT01490008
- Locations
- 🇩🇪
CardioSec Clinical Reasearch GmbH, Erfurt, Germany
Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II
- First Posted Date
- 2011-10-14
- Last Posted Date
- 2014-03-14
- Target Recruit Count
- 11
- Registration Number
- NCT01451723
- Locations
- 🇺🇸
LSu Health Sciences Center, New Orleans, Louisiana, United States
Study to Evaluate Safety and Toxicity of Polyphenon E (EGCG) in HIV-1-Infected Individuals
- First Posted Date
- 2011-09-13
- Last Posted Date
- 2023-05-19
- Lead Sponsor
- Baylor College of Medicine
- Target Recruit Count
- 23
- Registration Number
- NCT01433289
- Locations
- 🇺🇸
University of Texas Health Science Center Houston, Houston, Texas, United States
🇺🇸Baylor College of Medicine, Houston, Texas, United States
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
- First Posted Date
- 2010-02-02
- Last Posted Date
- 2020-04-09
- Lead Sponsor
- University of Chicago
- Target Recruit Count
- 20
- Registration Number
- NCT01060345
- Locations
- 🇺🇸
The University of Chicago, Chicago, Illinois, United States
Drug Development Updates
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