Clinical Trials
Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate tetracycline hydrochloride across dermatological, infectious, and oncological indications, including acne vulgaris, sexually transmitted infections, Helicobacter pylori colonization, non-Hodgkin lymphoma, and cancer therapy-emergent skin rashes. Sponsored by academic centers, university hospitals, and international research groups, these studies encompass recruitment statuses ranging from upcoming and actively recruiting to active non-recruiting and completed protocols. Highlighted research includes several clinical trials assessing Phase 2 prophylactic interventions for therapy-induced dermatological reactions and Phase 4 Helicobacter pylori eradication.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06509139 | ENROLLING_BY_INVITATION | Helicobacter Pylori Infection; Sex; Bismuth Quadruple Therapy |
National Cheng-Kung University Hospital |
2024-07-09 | PHASE4 |
| NCT07144657 | NOT_YET_RECRUITING | MALT Lymphoma of Stomach |
National Taiwan University Hospital |
2025-09-01 | PHASE2 |
| NCT07788053 | NOT_YET_RECRUITING | Helicobatcer Pylori; First-Line Eradication |
Chih-An Shih, MD |
2026-09-01 | |
| NCT04527055 | ENROLLING_BY_INVITATION | Helicobacter Pylori Infection; Dysbiosis; Probiotics |
National Cheng-Kung University Hospital |
2020-05-06 | PHASE4 |
| NCT07542639 | NOT_YET_RECRUITING | Pulp Disease, Dental; Pulp Necrosis; Pulp Therapy in Primary Molars; Primary Teeth; Pulpectomy; Endodontics; Dental Care for Children; Treatment Outcome; Quality of Life; Health Services Accessibility |
University of Sao Paulo |
2026-06-08 | EARLY_PHASE1 |
| NCT07757919 | NOT_YET_RECRUITING | HELICOBACTER PYLORI INFECTIONS |
Qilu Hospital of Shandong University |
2026-09-01 | PHASE4 |
| NCT07358130 | RECRUITING | Helicobacter Pylori Infection |
Kaohsiung Medical University |
2025-10-21 | |
| NCT07729293 | NOT_YET_RECRUITING | Helicobacter Pylori Infection; Dyspepsia; Gastrointestinal Adverse Effects |
Gala Servicios Clinicos S.L. |
2026-08-31 | |
| NCT06225570 | RECRUITING | Acne Vulgaris |
Medical University of South Carolina |
2025-02-01 | EARLY_PHASE1 |
| NCT05821478 | RECRUITING | Hidradenitis Suppurativa |
Institut Pasteur |
2025-05-22 | PHASE3 |
| NCT07139366 | RECRUITING | Gastritis; Dyspepsia; Helicobacter Pylori Infection; Gastric Cancer; Peptic Ulcer |
Yongquan Shi |
2025-10-28 | PHASE4 |
| NCT07320001 | NOT_YET_RECRUITING | Lymphatic Abnormality |
Basharat Hussain |
2026-01-26 | PHASE2 |
| NCT05061732 | UNKNOWN | Helicobacter Pylori Infection |
Shanghai Zhongshan Hospital |
2021-09-30 | PHASE4 |
| NCT05219929 | COMPLETED | Post-Treatment Lyme Disease |
Johns Hopkins University |
2022-11-02 | PHASE2 |
| NCT06977841 | COMPLETED | Helicobacter Pylori Eradication; Adverse Reaction |
Zhongshan Hospital (Xiamen), Fudan University |
2025-06-10 | |
| NCT06561711 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2024-08-21 | PHASE4 |
| NCT07738861 | COMPLETED | Postoperative Pain; Mandibular Molar Extraction; Tooth Extraction |
CMH Lahore Medical College and Institute of Dentistry |
2026-01-10 | PHASE4 |
| NCT07487142 | COMPLETED | H Pylori Infection |
Beni-Suef University |
2024-06-10 | PHASE3 |
| NCT05874570 | RECRUITING | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2023-06-20 | PHASE4 |
| NCT07068607 | RECRUITING | Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer |
Yongquan Shi |
2025-04-01 | PHASE4 |
| NCT06299605 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2024-11-27 | |
| NCT06723197 | RECRUITING | HELICOBACTER PYLORI INFECTIONS |
Shandong University |
2024-12-10 | PHASE4 |
| NCT06695559 | COMPLETED | Periimplantitis; Periimplant Diseases |
Aristotle University Of Thessaloniki |
2024-02-05 | PHASE4 |
| NCT05874544 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2023-05-16 | PHASE4 |
| NCT06225570 | Not yet recruiting | Acne Vulgaris |
Medical University of South Carolina |
2025-01 | Early Phase 1 |
| NCT02754583 | COMPLETED | Trachoma |
University of California, San Francisco |
2015-12-05 | PHASE3 |
| NCT05850117 | UNKNOWN | Helicobacter Pylori Eradication |
Kaohsiung Medical University |
2020-02-10 | |
| NCT06351891 | UNKNOWN | Helicobacter Pylori Infection |
Qilu Hospital of Shandong University |
2024-04 | PHASE4 |
| NCT06168214 | UNKNOWN | the Eradication Rates of Helicobacter Pylori |
Xijing Hospital of Digestive Diseases |
2023-09-04 | PHASE4 |
| NCT06759610 | COMPLETED | Ameloblastoma |
Minia University |
2024-02-10 | |
| NCT05802888 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2023-03-12 | PHASE4 |
| NCT06168084 | COMPLETED | Gastritis Dyspepsia Helicobacter Pylori Infection Gastric Cancer Peptic Ulcer |
Yongquan Shi |
2023-06-06 | PHASE4 |
| NCT05431075 | COMPLETED | Helicobacter Pylori Infection |
Shandong University |
2022-07-01 | PHASE4 |
| NCT05432115 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2022-06-25 | PHASE4 |
| NCT04901117 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2021-06 | PHASE4 |
| NCT04762134 | Recruiting | Bacterial Sexually Transmitted Diseases |
Jonathan Troy Grennan|Canadian Institutes of Health Research (CIHR)|British Columbia Centre for Disease Control |
2023-06-02 | Phase 4 |
| NCT05049902 | COMPLETED | Helicobacter Pylori Infection |
Shandong University |
2021-09-21 | PHASE4 |
| NCT05345210 | UNKNOWN | Helicobacter Pylori |
Xijing Hospital of Digestive Diseases |
2022-04-25 | PHASE4 |
| NCT05250050 | WITHDRAWN | Helicobacter Pylori Infection |
Shanghai Zhongshan Hospital |
2022-03-25 | PHASE4 |
| NCT05018923 | UNKNOWN | Helicobacter Pylori Infection |
Shanghai Zhongshan Hospital |
2021-08-24 | PHASE4 |
| NCT04531059 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2020-10-15 | PHASE4 |
| NCT02359331 | TERMINATED | Helicobacter Infection |
Seoul National University Bundang Hospital |
2014-08 | |
| NCT03908892 | UNKNOWN | Paronychia |
Guangzhou University of Traditional Chinese Medicine |
2019-06-12 | |
| NCT04264663 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2019-11-01 | PHASE4 |
| NCT04879992 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2021-05-07 | |
| NCT05135182 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2021-11-28 | PHASE4 |
| NCT04122287 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2019-11-01 | PHASE4 |
| NCT04853875 | COMPLETED | Helicobacter Pylori Infection |
Mackay Memorial Hospital |
2021-04-19 | PHASE4 |
| NCT05129176 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2021-11-23 | PHASE4 |
| NCT04991584 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2021-08-04 | |
| NCT05126121 | UNKNOWN | Helicobacter Pylori Infection |
Xiuli Zuo |
2021-11-20 | |
| NCT03779074 | COMPLETED | Helicobacter Pylori Infection |
Kaohsiung Veterans General Hospital. |
2018-09-03 | PHASE3 |
| NCT04678492 | COMPLETED | Gastritis; Dyspepsia; Helicobacter Pylori Infection; Gastric Cancer; Peptic Ulcer |
Xijing Hospital of Digestive Diseases |
2020-12-20 | PHASE4 |
| NCT03555526 | UNKNOWN | H Pylori Infection |
National Taiwan University Hospital |
2017-12-15 | PHASE4 |
| NCT04716426 | COMPLETED | COVID-19 |
University of Nove de Julho |
2021-01-28 | |
| NCT04107194 | UNKNOWN | Helicobacter Pylori Infection; Antibiotic Resistant Infection; Antibiotic Resistant Strain |
University of Bari |
2020-01-14 | PHASE3 |
| NCT03892330 | NOT_YET_RECRUITING | 0.5-14 Year Old Children With Nephroblastoma |
Shengjing Hospital |
2019-06-01 | PHASE4 |
| NCT04039126 | UNKNOWN | Malignant Pleural Effusion |
University College Hospital, Ibadan |
2019-06-20 | PHASE1 |
| NCT04730674 | COMPLETED | Post-mastectomty Seroma |
Zagazig University |
2020-01-01 | |
| NCT03726099 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2019-03-15 | PHASE4 |
| NCT03377933 | UNKNOWN | Efficacy; Gastric Microbiota; Safety |
Yiqi Du |
2019-03-15 | |
| NCT03208426 | UNKNOWN | Helicobacter Pylori Infection |
National Taiwan University Hospital |
2017-10-01 | PHASE4 |
| NCT03658746 | COMPLETED | Helicobacter Pylori Infection |
Shandong University |
2019-01-01 | PHASE4 |
| NCT03571230 | UNKNOWN | Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing |
Shandong University |
2018-07-01 | PHASE4 |
| NCT03656484 | COMPLETED | Chronic Periodontitis |
Concordia Dent Srl |
2019-01-15 | PHASE2 |
| NCT03616405 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2019-04-01 | PHASE4 |
| NCT03708848 | COMPLETED | Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2018-12-05 | PHASE4 |
| NCT03658733 | UNKNOWN | Helicobacter Pylori Infection |
Shandong University |
2018-12-15 | PHASE4 |
| NCT03609892 | COMPLETED | Gastric Ulcer; Chronic Gastritis; Gastric Cancer; Helicobacter Pylori Infection; Gastritis |
Xijing Hospital of Digestive Diseases |
2018-08-01 | PHASE4 |
| NCT02864550 | Active not recruiting | Syphilis|Sexually Transmitted Infections |
British Columbia Centre for Disease Control |
2019-08-15 | Phase 4 |
| NCT04066257 | COMPLETED | Healthy |
HK inno.N Corporation |
2019-01-17 | PHASE1 |
| NCT03925818 | TERMINATED | Helicobacter Pylori Infection |
Università degli Studi di Sassari |
2017-08-29 | |
| NCT02490839 | COMPLETED | Helicobacter Pylori Infection |
National Taiwan University Hospital |
2015-07 | PHASE4 |
| NCT03632733 | UNKNOWN | Keratotic Nodular Size |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2018-01-21 | PHASE2 |
| NCT02741414 | UNKNOWN | Gastritis |
Taizhou Hospital |
2016-06 | |
| NCT02483715 | COMPLETED | Helicobacter Pylori Infection |
National Taiwan University Hospital |
2015-07 | PHASE4 |
| NCT02576652 | COMPLETED | Osteoporosis |
Amgen |
2015-12-22 | PHASE4 |
| NCT02978157 | COMPLETED | Helicobacter Pylori Infection |
Kaohsiung Veterans General Hospital. |
2015-02 | |
| NCT02988089 | UNKNOWN | Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing |
Shandong University |
2017-04-20 | PHASE4 |
| NCT03139253 | UNKNOWN | Antimicrobial Susceptibility Testing; Triple Therapy |
Yanqing Li |
2017-05-30 | PHASE4 |
| NCT03494972 | COMPLETED | Post-Operative Wound Infection |
University of Oslo |
2016-01-02 | |
| NCT03095378 | COMPLETED | Gingival Recession |
University of Sao Paulo |
2014-03-10 | |
| NCT03634605 | COMPLETED | Primary Spontaneous Pneumothorax |
Isfahan University of Medical Sciences |
2015-05-05 | |
| NCT02045251 | WITHDRAWN | Treatment of H. Pylori Infection |
American University of Beirut Medical Center |
2013-06 | PHASE4 |
| NCT03146325 | WITHDRAWN | Helicobacter Pylori Infection |
The University of Texas Health Science Center, Houston |
2012-11 | PHASE4 |
| NCT02175927 | COMPLETED | Helicobacter Pylori Treatment Failure |
Shanghai Jiao Tong University School of Medicine |
2014-07 | PHASE4 |
| NCT02159976 | COMPLETED | Helicobacter Pylori Infection |
Seoul National University Bundang Hospital |
2014-07 | |
| NCT01763437 | WITHDRAWN | Chalazia; Chalazion |
The Cleveland Clinic |
2014-03 | EARLY_PHASE1 |
| NCT01481844 | COMPLETED | Optimization of Second Line Treatment Protocol for H Pylori Eradication |
Soroka University Medical Center |
2011-11 | PHASE3 |
| NCT01880515 | COMPLETED | Skin Rash; Lung Cancer |
Instituto Nacional de Cancerologia de Mexico |
2010-12 | PHASE2 |
| NCT01753856 | COMPLETED | Osteoporosis |
Eli Lilly and Company |
2013-01 | PHASE4 |
| NCT01742429 | COMPLETED | Cure Rate of Helicobacter Pylori Infection |
Shanghai Jiao Tong University School of Medicine |
2012-11 | PHASE4 |
| NCT02259543 | COMPLETED | Gingival Recession |
University of Sao Paulo |
2011-08 | |
| NCT01628549 | COMPLETED | Acne Vulgaris |
Almirall, S.A. |
2012-06-30 | PHASE2 |
| NCT01863823 | COMPLETED | Oral Helicobacter Pylori |
Ameritek USA |
2011-08 | PHASE1; PHASE2 |
| NCT01668927 | COMPLETED | Functional Dyspepsia; Scarred Peptic Ulcer |
Shanghai Jiao Tong University School of Medicine |
2012-07 | PHASE4 |
| NCT01010295 | COMPLETED | Non-Hodgkin Lymphoma |
International Extranodal Lymphoma Study Group (IELSG) |
2006-09 | PHASE2 |
| NCT02057926 | COMPLETED | Ridge Preservation Technique |
Universitat Internacional de Catalunya |
2009-11 | PHASE2 |
| NCT00469261 | COMPLETED | Myocardial Infarction; Left Ventricular Remodeling |
Careggi Hospital |
2007-05 | PHASE2 |
| NCT01335334 | UNKNOWN | H. Pylori Infection |
The University of Texas Health Science Center, Houston |
2011-03 | PHASE4 |
| NCT01573975 | COMPLETED | Helicobacter Pylori Infection |
Buddhist Tzu Chi General Hospital |
2009-01 | PHASE4 |
| NCT01293643 | COMPLETED | Vaginosis, Bacterial; Candidiasis, Vulvovaginal |
Merck Sharp & Dohme LLC |
2010-05 | PHASE3 |
| NCT01792700 | COMPLETED | Helicobacter Infections |
Seoul National University Bundang Hospital |
2003-01 | PHASE4 |
| NCT01032499 | UNKNOWN | Acne Vulgaris II or III Degree; Boils |
Laboratorios Goulart S.A. |
2010-05 | PHASE3 |
| NCT00841854 | COMPLETED | Helicobacter Infection |
Asan Medical Center |
2008-06 | PHASE4 |
| NCT00889356 | UNKNOWN | Candidiasis; Bacterial Vaginosis |
Zodiac Produtos Farmaceuticos S.A. |
2009-09 | PHASE3 |
| NCT00361257 | TERMINATED | HIV Infections |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2007-03 | PHASE2 |
| NCT00669955 | COMPLETED | Helicobacter Infections |
Forest Laboratories |
2008-06 | PHASE3 |
| NCT00243893 | COMPLETED | Aneurysms; Arteriovenous Malformations |
University of California, San Francisco |
2004-07 | PHASE1 |
| NCT00591162 | TERMINATED | Burn |
The University of Texas Medical Branch, Galveston |
1992-10 | PHASE2; PHASE3 |
| NCT00336154 | WITHDRAWN | Epidermolysis Bullosa |
Rambam Health Care Campus |
PHASE4 | |
| NCT00091247 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Alliance for Clinical Trials in Oncology |
2004-12 | |
| NCT01098448 | COMPLETED | Periodontitis |
The Forsyth Institute |
1999-09 | PHASE3 |
| NCT00347776 | COMPLETED | Trichiasis |
Johns Hopkins University |
2001-08 | PHASE4 |
| NCT00002682 | COMPLETED | Lymphoma |
M.D. Anderson Cancer Center |
1995-08-10 | PHASE2 |
| NCT00003151 | COMPLETED | Lymphoma |
European Organisation for Research and Treatment of Cancer - EORTC |
1997-09 | PHASE2 |
| NCT00355459 | WITHDRAWN | Dry Eye Syndrome |
University of Texas Southwestern Medical Center |
2005-08 |
(data from https://clinicaltrials.gov, updated on 2024-11-07)
Check the
Tetracycline HCl
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
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>).
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Note: Technical data last updated: Sep 1, 2026.