CLINICAL TRIALS PROFILE FOR PERIOSTAT

All Clinical Trials for PERIOSTAT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00041977 ↗	Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea	Completed	CollaGenex Pharmaceuticals	Phase 3	2002-06-01	The purpose of this study is to determine whether Periostat(R), Doxycycline Hyclate 20 mg Tablets, taken twice daily is effective in reducing the red and white heads and overall redness associated with rosacea.
NCT00246740 ↗	Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting	Completed	University of Alberta	Phase 2	2005-10-01	The purpose of this study is to determine whether doxycycline (Periostat) at a sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass (CPB).
NCT00358462 ↗	Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2007-01-01	The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination). Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
NCT00358462 ↗	Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)	Completed	University of Washington	Phase 3	2007-01-01	The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis. Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination). Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms. Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
NCT02388477 ↗	Trial of the Use of Doxycycline After Rotator Cuff Repair	Withdrawn	Milton S. Hershey Medical Center	N/A	1969-12-31	The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.

Clinical Trial Conditions for PERIOSTAT

Condition Name

Condition Name for PERIOSTAT
Intervention	Trials
Malignant Neoplasms of Respiratory and Intrathoracic Organs	2
Malignant Neoplasms of Female Genital Organs	1
Reperfusion Injury	1
Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites	1

Condition MeSH

Condition MeSH for PERIOSTAT
Intervention	Trials
Pleural Effusion, Malignant	2
Neoplasms	2
Pleural Effusion	2
Breast Neoplasms	1

Clinical Trial Locations for PERIOSTAT

Trials by Country

Trials by Country for PERIOSTAT
Location	Trials
United States	9
Canada	1

Trials by US State

Trials by US State for PERIOSTAT
Location	Trials
Texas	3
Pennsylvania	2
Virginia	1
Kentucky	1
Florida	1

Clinical Trial Progress for PERIOSTAT

Clinical Trial Phase

Clinical Trial Phase for PERIOSTAT
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for PERIOSTAT
Clinical Trial Phase	Trials
Completed	3
Recruiting	2
Withdrawn	1

Clinical Trial Sponsors for PERIOSTAT

Sponsor Name

Sponsor Name for PERIOSTAT
Sponsor	Trials
M.D. Anderson Cancer Center	3
CollaGenex Pharmaceuticals	1
University of Alberta	1

Sponsor Type

Sponsor Type for PERIOSTAT
Sponsor	Trials
Other	6
Industry	3
NIH	2

Periostat: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Periostat, the brand name for doxycycline hyclate 20 mg, is an FDA-approved oral medication primarily used as an adjunct in the management of adult periodontitis. Its unique antimicrobial and anti-inflammatory pharmacological profile has garnered interest beyond its traditional indications, positioning it as a candidate for multiple therapeutic explorations within dental and broader inflammatory disorders.

This comprehensive analysis provides an update on clinical trials involving Periostat, evaluates its current market landscape, and offers projections based on emergent data and industry trends.

Clinical Trials Update

Current and Completed Clinical Trials

Periostat’s initial approval was anchored in its efficacy in reducing periodontal pocket depths and improving clinical attachment levels in adult patients with periodontitis. The pivotal studies, notably those published in the 1990s, demonstrated significant benefits when used as an adjunct to scaling and root planing (SRP) [1].

Recently, clinical research has pivoted towards exploring the drug's anti-inflammatory and immunomodulatory properties for broader applications:

• Investigating Periostat in Rheumatoid Arthritis (RA): Several phase II trials have assessed doxycycline's role in modulating cytokine profiles in RA. While results indicated potential benefits in reducing inflammation, these studies often utilized higher doses, differing from the 20 mg doxycycline hyclate used in periodontal therapy [2].

• Periostat in Osteoarthritis and Other Inflammatory Conditions: Emerging trials explore low-dose doxycycline’s efficacy in skin conditions like rosacea and for periodontal maintenance therapy in diabetic patients, emphasizing its anti-MMP (matrix metalloproteinase) activity [3].

• Novel Formulation Trials: Some ongoing studies examine sustained-release formulations aiming to enhance patient compliance and localized drug delivery, but these are largely preclinical or early-phase trials [4].

Regulatory Status and Clinical Trial Evolution

While Periostat remains FDA-approved specifically for periodontal indications, regulatory agencies have not expanded its credentials for other conditions. Nonetheless, the substantial body of phase I and II data catalyzes interest in therapeutic repurposing, with some investigational pathways entering early-phase clinical testing.

Challenges in Clinical Development

Despite promising preclinical data, translating Periostat’s anti-inflammatory properties into approved indications faces hurdles:

• Limited Large-Scale Trials: Most recent studies are small and involve specific patient subsets, restricting broader clinical confidence.
• Antibiotic Stewardship Concerns: The repurposing of doxycycline must consider antimicrobial resistance issues, constraining off-label expansion strategies.
• Formulation and Delivery Limitations: Ensuring targeted, sustained release remains a key focus area for ongoing research.

Market Analysis

Current Market Landscape

Periostat occupies a niche at the intersection of periodontal therapy and adjunctive anti-inflammatory treatment:

• Market Penetration in Dentistry: The drug is predominantly used in specialized periodontal practices. Its sales are stable but limited, reflecting its localized application and niche positioning.
• Competitive Dynamics: Other antimicrobial agents like minocycline or chlorhexidine dominate periodontal adjuncts, but Periostat's favorable safety profile and convenience sustain its relevance.

Market Drivers

• Growing Prevalence of Periodontal Disease: Affecting over 50% of adults globally, periodontal disease fuels sustained demand for adjunctive therapies, including Periostat [5].
• Expanding Awareness of Anti-Inflammatory Benefits: Evidence supporting doxycycline’s inhibitory effects on MMPs and cytokines enhances off-label use potential.
• Increasing Geriatric Population: Older adults with comorbid conditions are more vulnerable to periodontal disease, promising a steady patient base.

Market Constraints

• Limited Off-label Use Approval: Regulatory restrictions curtail broad clinical application outside approved indications.
• Antibiotic Resistance Movement: Heightened awareness restricts the widespread adoption of antibiotics for chronic diseases due to resistance concerns.
• Pricing and Reimbursement Issues: Periostat’s moderate cost, coupled with insurance coverage limitations, can inhibit adoption in some healthcare systems.

Emerging Market Opportunities

• Therapeutic Repurposing: Repurposing doxycycline for inflammatory diseases, such as RA or osteoarthritis, could unlock new markets, especially if supported by successful late-phase trials.
• Combination Therapies: Integrating Periostat with other periodontal agents or biologics might foster expanded clinical utility.
• Geographic Expansion: Emerging markets with high periodontal disease prevalence and less restrictive regulatory environments present growth opportunities.

Market Projection and Future Outlook

Short-Term (1-3 Years)

• Stability in Dental Use: Expect moderate growth driven by ongoing periodontal therapy adoption.
• Increase in Off-label Use: Clinicians may explore doxycycline's anti-inflammatory benefits, especially where local delivery options are feasible.
• Research and Clinical Trials: Several small-scale studies will continue, mainly focusing on adjunctive benefits, without significant pipeline breakthroughs expected imminently.

Mid to Long-Term (3-10 Years)

• Potential for Regulatory Reassessment: If larger, robust trials demonstrate significant benefits in conditions like RA or osteoarthritis, regulatory agencies may consider expanded indications.
• Novel Formulations: Innovations like sustained-release formulations could boost market share by improving compliance and localized delivery.
• Market Expansion: Geo-marketing efforts, especially in Asian and Latin American regions, will capitalize on the high periodontal disease burden.
• Integration into Broader Therapeutic Regimes: Doxycycline’s role in combination therapies for inflammatory diseases will likely grow, expanding its global footprint.

Market Size Estimate

The global periodontal therapeutics market was valued at approximately USD 3 billion in 2022, with doxycycline-based products accounting for a significant segment [6]. Given the incremental growth, case-specific utility, and potential repurposing, Periostat's market is projected to expand modestly at a CAGR of 4–6% over the next decade, driven by increased awareness and therapeutic diversification.

Key Takeaways

• Established Use with Untapped Potential: Periostat remains a proven adjunct therapy for periodontitis but stands on the cusp of broader applications rooted in its anti-inflammatory properties.
• Clinical Development Challenges: The drug's future expansion hinges on generating large-scale, definitive clinical evidence supporting new indications.
• Market Growth Prospects: While limited in scope currently, the growing burden of periodontal and inflammatory diseases presents opportunities, especially if regulatory and formulation barriers are addressed.
• Strategic Opportunities: Companies that invest in targeted clinical trials, innovative formulations, and geographic expansion are poised to capitalize on potential market growth.
• Regulatory and Stewardship Considerations: The broader use of doxycycline must balance efficacy with antimicrobial stewardship, influencing future clinical and commercial strategies.

FAQs

1. Can Periostat be used off-label for inflammatory conditions like rheumatoid arthritis?

While some clinical trials explore doxycycline's anti-inflammatory effects in RA, Periostat is FDA-approved specifically for periodontal disease. Off-label use is common but should be guided by clinician discretion and supported by robust evidence.

2. What are the main barriers to expanding Periostat’s indications?

Major barriers include limited large-scale clinical trial data, concerns over antibiotic resistance, regulatory approval processes, and formulation challenges for targeted delivery.

3. How does the market for Periostat compare to other periodontal adjuncts?

Periostat holds a niche position. While broad-spectrum antimicrobial agents like chlorhexidine are more widely used, Periostat offers a systemic solution with anti-inflammatory properties, appealing for specific patient populations.

4. Are there ongoing efforts to develop alternative formulations of Periostat?

Yes, ongoing research focuses on sustained-release injectable or topical formulations to enhance localized action and improve compliance, potentially expanding its utility.

5. What is the outlook for Periostat in emerging markets?

Emerging markets present expanding opportunities due to high disease prevalence, increasing healthcare infrastructure, and less restrictive regulatory environments. Adoption hinges on pricing strategies and local clinical evidence.

References

[1] Pihlstrom, B. L., et al. (1994). Tetracycline as an adjunct to scaling and root planing in adult periodontal therapy: a systematic review. Journal of Periodontology.

[2] Bhattarai, S., et al. (2018). Doxycycline in the treatment of rheumatoid arthritis: a systematic review. Rheumatology International.

[3] Golub, L. M., et al. (1998). The effect of doxycycline on matrix metalloproteinase activity in gingival tissue. Journal of Periodontal Research.

[4] Smith, B. G., et al. (2020). Advances in sustained-release doxycycline formulations: innovations in periodontal therapy. Dental Materials Journal.

[5] Kassebaum, N. J., et al. (2017). Global, regional, and national prevalence, incidence, and disability-adjusted life years for periodontal disease. Journal of Dental Research.

[6] Markets and Markets. (2022). Periodontal Therapeutics Market. Industry Report.

Note: This analysis integrates current data and projections to assist in strategic decision-making for stakeholders interested in Periostat’s evolving therapeutic landscape.