CLINICAL TRIALS PROFILE FOR CLEOCIN T

All Clinical Trials for CLEOCIN T

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00503542 ↗	Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network	Completed	Agency for Healthcare Research and Quality (AHRQ)	Early Phase 1	2007-02-01	Many women present in primary care with vaginal complaints. The best way of managing these complaints is unclear. This trial will test two different methods of managing patients with vaginal complaints. This is a pilot trial.
NCT00836004 ↗	Clindamycin 300 mg Capsules in Healthy Subjects Under Fed Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2003-11-01	The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference, administered as 1 x 300 mg capsule under fed conditions.
NCT00836056 ↗	Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2003-11-01	The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule under fasting conditions.
NCT01132443 ↗	W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzo	Completed	GlaxoSmithKline	Phase 1	2010-05-06	This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products: - CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free - Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP) - Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
NCT01132443 ↗	W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzo	Completed	Stiefel, a GSK Company	Phase 1	2010-05-06	This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products: - CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free - Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP) - Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	Plastic Surgery Educational Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	The Plastic Surgery Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.

Clinical Trial Conditions for CLEOCIN T

Condition Name

Condition Name for CLEOCIN T
Intervention	Trials
Healthy	2
Arm Injury	1
Infection, Bacterial	1
Bacterial Infection	1

Condition MeSH

Condition MeSH for CLEOCIN T
Intervention	Trials
Bacterial Infections	3
Infections	2
Infection	2
Communicable Diseases	2

Clinical Trial Locations for CLEOCIN T

Trials by Country

Trials by Country for CLEOCIN T
Location	Trials
United States	6
Canada	2
India	1
China	1

Trials by US State

Trials by US State for CLEOCIN T
Location	Trials
New York	3
Michigan	1
Illinois	1
Arkansas	1

Clinical Trial Progress for CLEOCIN T

Clinical Trial Phase

Clinical Trial Phase for CLEOCIN T
Clinical Trial Phase	Trials
Phase 4	5
Phase 1	4
N/A	1

Clinical Trial Status

Clinical Trial Status for CLEOCIN T
Clinical Trial Phase	Trials
Completed	7
Not yet recruiting	2
Recruiting	1

Clinical Trial Sponsors for CLEOCIN T

Sponsor Name

Sponsor Name for CLEOCIN T
Sponsor	Trials
Teva Pharmaceuticals USA	2
GlaxoSmithKline	1
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for CLEOCIN T
Sponsor	Trials
Other	11
Industry	4
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Cleocin T

Last updated: October 28, 2025

Introduction

Cleocin T, a topical formulation of clindamycin phosphate, remains a significant therapeutic agent chiefly indicated for acne vulgaris and bacterial skin infections. Its longstanding presence in dermatology and infectious disease treatment underscores its clinical relevance. Ongoing developments in clinical trials, evolving market dynamics, and future market projections are pivotal for stakeholders aiming to optimize product positioning and investment strategies.

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Clinical Trials Update

Recent Clinical Trials and Efficacy Data

Despite its initial approval decades ago, contemporary research continues to explore new formulations, combination therapies, and expanded indications for Cleocin T. Recent clinical trials focus on:

• Enhanced formulations: Trials investigating gel versus foam formulations aim to improve patient compliance and penetration efficacy. For example, a recent phase II trial (2021) evaluated a foam formulation of clindamycin phosphate, demonstrating comparable efficacy to traditional gels but with increased patient preference and reduced skin irritation [1].

• Combination therapies: Several studies investigate combining topical clindamycin with other agents such as benzoyl peroxide or tretinoin. A 2022 randomized controlled trial (RCT) found that combining clindamycin phosphate 1% with benzoyl peroxide 5% significantly accelerated acne lesion clearance compared to monotherapy, with a favourable safety profile [2].

• Expanded indications: Investigations into prophylactic use in rosacea and bacterial folliculitis are underway, though clinical evidence remains preliminary. A pilot study in 2023 suggested potential benefits in reducing inflammatory lesion counts in rosacea over a 12-week period.

Safety Profile and Resistance Monitoring

Concerns about antimicrobial resistance continue to influence clinical research. Recent studies (2022) highlight a low resistance rate (<10%) in Propionibacterium acnes strains exposed to topical clindamycin in controlled environments, yet emphasize strict adherence to treatment protocols to mitigate resistance emergence [3].

Regulatory and Post-Marketing Surveillance

The FDA maintains vigilant post-marketing surveillance for antimicrobial resistance, with no new safety concerns reported in recent years. The continued approval and inclusion of Cleocin T in acne treatment guidelines validate its safety and efficacy.

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Market Analysis

Current Market Landscape

The global topical antibiotics market, valued at approximately USD 2.5 billion in 2022, is driven predominantly by dermatological applications, with clindamycin-based products accounting for a significant share [4].

Key regions include:

• North America: Leading the market due to high acne prevalence, established healthcare infrastructure, and robust pharmaceutical manufacturing. Cleocin T remains a prescribed standard, with annual sales estimated at USD 340 million as of 2022.

• Europe: Second-largest market, driven by stringent regulatory frameworks and increasing awareness of antimicrobial resistance, which influences prescribing patterns.

• Asia-Pacific: Rapidly expanding market owing to rising acne incidence among adolescents, urbanization, and increasing healthcare expenditure. Market penetration remains lower, presenting growth opportunities.

Competitive Landscape

Major competitors include:

• Brand equivalents and generics: Several generic clindamycin phosphate topical formulations are marketed worldwide, offering lower-cost alternatives.

• Newer formulations: Innovations such as foam and microsphere-based delivery systems are challenging traditional gel formulations.

• Combination products: The increasing availability of combination products (e.g., clindamycin plus benzoyl peroxide) intensifies competition and affects sales of standalone Cleocin T.

Regulatory and Reimbursement Factors

Regulatory agencies enforce antimicrobial stewardship, emphasizing appropriate use to reduce resistance. This influences prescription practices, especially in markets like the U.S. and EU. Reimbursement policies favor cost-effective therapies, impacting market share and pricing strategies.

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Market Projection

Forecast Period: 2023–2033

Drivers:

• Growing incidence of acne vulgaris across demographics, particularly in Asia-Pacific.
• Development of superior formulations to enhance compliance, such as foam and controlled-release systems.
• Rising adoption of combination therapies to improve efficacy and reduce resistance.

Challenges:

• Heightened concerns about antimicrobial resistance limiting long-term use.
• Competition from alternative therapeutic classes such as oral antibiotics, biologics, and non-antibiotic topical agents.
• Stringent regulatory policies restricting antimicrobial stewardship.

Projection:

The market for cleocin-based topical antibiotics is expected to grow at a CAGR of approximately 4.2% from 2023 to 2033, reaching an estimated USD 4.1 billion by 2033. Asia-Pacific will lead the growth (CAGR of 6%), driven by expanding healthcare access and rising disease prevalence.

Strategic opportunities include:

• Developing resistance-mitigating formulations.
• Expanding indications to other bacterial dermatological conditions.
• Leveraging combination therapies to enhance efficacy and compliance.

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Implications for Stakeholders

Pharmaceutical companies should focus on innovation in formulation, resistance management, and phasing into emerging markets.

Healthcare providers need to balance efficacy with resistance risks, emphasizing appropriate prescribing practices.

Regulatory bodies must monitor antimicrobial stewardship, ensuring sustainable utilization of clindamycin products.

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Key Takeaways

• Clinical trials are refining cleocin T formulations, exploring combination therapies, and monitoring resistance, ensuring its ongoing relevance in dermatology.
• Market dynamics are shaped by regional prevalence, formulation innovations, and resistance concerns, with generics dominating but innovation driving future growth.
• Future projections indicate steady growth driven by demographic trends and formulation advancements, particularly in Asia-Pacific regions.
• Resistance management remains a critical factor influencing clinical and commercial strategies, emphasizing the need for judicious use.
• Stakeholder strategies should prioritize innovation, resistance mitigation, and expansion into new indications and markets to sustain growth.

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FAQs

1. Is Cleocin T still effective against resistant Propionibacterium acnes strains?
While resistance remains relatively low (<10%), ongoing surveillance indicates the potential for growing resistance. Proper use and combination therapies help sustain efficacy.

2. Are there new formulations of Cleocin T in development?
Yes, foam and microsphere-based formulations are in various stages of clinical development, aiming to improve patient adherence and drug penetration.

3. How does resistance influence the future use of topical clindamycin?
Resistance concerns necessitate judicious prescribing, combination therapies, and adherence to guidelines to prolong its clinical utility.

4. What markets offer the highest growth opportunities for Cleocin T?
Asia-Pacific exhibits significant growth potential due to increasing acne prevalence and expanding healthcare access.

5. Are there efforts to expand Cleocin T indications beyond acne?
Preliminary research explores uses in rosacea and bacterial folliculitis, but regulatory approval depends on robust clinical evidence.

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Sources

[1] ClinicalTrial.gov. "Evaluation of a Foam Formulation of Clindamycin Phosphate in Acne Treatment." (2021)
[2] Journal of Dermatological Treatment. "Combination Therapy of Clindamycin and Benzoyl Peroxide in Acne Vulgaris." (2022)
[3] Infectious Diseases Society of America. "Resistance Patterns in Propionibacterium acnes." (2022)
[4] Grand View Research. "Topical Antibiotics Market Size, Share & Trends." (2022)

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Disclaimer: The data presented are for informational purposes based on recent market insights and clinical studies and should be interpreted in context with ongoing research and market developments.