Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 4 evaluate doxycycline hyclate across dermatological, infectious, ophthalmological, and connective tissue disorders, including acne vulgaris, wet age-related macular degeneration, chronic periodontitis, Helicobacter pylori-associated duodenal ulcers, and sexually transmitted infections such as gonorrhea, chlamydia, and syphilis. Sponsored by pharmaceutical entities such as Warner Chilcott and Galderma R&D alongside academic centers like the University of Iowa and the University of California, San Francisco, these completed, active, and recruiting studies evaluate clinical efficacy, matrix metalloproteinase inhibition, and post-exposure prophylaxis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06738407 RECRUITING
Gonorrhea; Chlamydia; Syphilis; Sexually Transmitted Infections (STIs)
Westat
 2026-02-27 PHASE4
NCT07688096 NOT_YET_RECRUITING
Ehlers-Danlos Syndrome Hypermobility Type (hEDS); Ehlers-Danlos Syndrome (EDS); Joint Hypermobility; Joint Instability; Hypermobility Spectrum Disorder; Chronic Pain Syndrome; Musculoskeletal Pain; Sprain; Subluxation; Dislocation; Craniocervical Disfunction
Manhattan Pain Medicine, PLLC
 2026-07-15 PHASE1; PHASE2
NCT04504123 RECRUITING
Exudative Macular Degeneration; Wet Age-related Macular Degeneration
University of Iowa
 2020-11-04 PHASE2
NCT04762134 RECRUITING
Bacterial Sexually Transmitted Diseases
Jonathan Troy Grennan
 2023-06-02
NCT04582383 ACTIVE_NOT_RECRUITING
Acne
University of Pennsylvania
 2022-03-30 PHASE4
NCT05112211 RECRUITING
Thyroid Associated Ophthalmopathy
Sun Yat-sen University
 2022-01-01
NCT04686799 COMPLETED
Lateral Epicondylitis; Lateral Epicondylitis, Left Elbow; Lateral Epicondylitis, Right Elbow; Lateral Epicondylitis, Unspecified Elbow; Lateral Epicondylitis (Tennis Elbow) Bilateral; Medial Epicondylitis; Medial Epicondylitis, Right Elbow; Medial Epicondylitis, Left Elbow
Hospital for Special Surgery, New York
 2020-12-03 PHASE1
NCT03508232 COMPLETED
ST Segment Elevation Myocardial Infarction; Heart Failure
University of Alberta
 2020-01-06 PHASE2
NCT06172686 UNKNOWN
Controlled Human Malaria Infection; Induced Blood Stage Malaria Infection; Malaria Transmission; Malaria Challenge
Ifakara Health Institute
 2024-01-09 PHASE1
NCT05875506 COMPLETED
Osteitis; Dry Socket
Minia University
 2023-05-01
NCT03980223 COMPLETED
Gonorrhea; Chlamydia; Syphilis
University of California, San Francisco
 2019-11-26 PHASE4
NCT02203682 UNKNOWN
Graves Ophthalmopathy; Graves Disease; Thyroid-associated Ophthalmopathy; Thyroid Diseases; Endocrine System Diseases; Eye Diseases, Hereditary; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases
Sun Yat-sen University
 2014-07 PHASE2
NCT05399290 COMPLETED
Acne Vulgaris; Pediatrics
Michigan State University
 2020-11-19 PHASE4
NCT04451330 COMPLETED
Acne Vulgaris
Galderma R&D
 2020-07-29 PHASE4
NCT03397004 COMPLETED
Hereditary Hemorrhagic Telangiectasia (HHT)
Unity Health Toronto
 2018-09-12 PHASE2
NCT03342456 COMPLETED
Duodenal Ulcer Due to Helicobacter Pylori
The Third Xiangya Hospital of Central South University
 2017-12-13 PHASE4
NCT02899000 COMPLETED
Acne Vulgaris
Galderma R&D
 2016-07-29 PHASE4
NCT01499225 COMPLETED
Chronic Periodontitis
Yuhan Corporation
 2011-12 PHASE2
NCT01087476 UNKNOWN
Mucositis
Metropolitan Autonomous University
 2010-05 PHASE2
NCT00688064 COMPLETED
Severe Acne Vulgaris
Galderma R&D
 2008-08 PHASE3
NCT00635609 COMPLETED
Acne Vulgaris
Warner Chilcott
 2008-03 PHASE4
NCT00495313 COMPLETED
Rosacea
CollaGenex Pharmaceuticals
 2007-03 PHASE4
NCT00066027 COMPLETED
Periodontitis
University of Nebraska
 2002-06-01 PHASE3
NCT00041977 COMPLETED
Acne Rosacea
CollaGenex Pharmaceuticals
 2002-06 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-05-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doxycycline hyclate reversibly binds to the 30S ribosomal subunit to inhibit bacterial protein synthesis, while concurrently inhibiting matrix metalloproteinases (MMPs) to reduce extracellular matrix degradation and inflammatory cytokine production. This dual antimicrobial and anti-inflammatory activity suppresses bacterial pathogen proliferation and tissue remodeling, mitigating clinical pathologies such as bacterial sexually transmitted infections, acne vulgaris, and matrix metalloproteinase-driven exudative macular degeneration.

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.