CLINICAL TRIALS PROFILE FOR BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

All Clinical Trials for benzoyl peroxide; clindamycin phosphate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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)
NCT01015638 ↗	Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications	Completed	GlaxoSmithKline	Phase 4	2009-08-01	This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.
NCT01015638 ↗	Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications	Completed	Stiefel, a GSK Company	Phase 4	2009-08-01	This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.
NCT00807014 ↗	Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne	Completed	GlaxoSmithKline	Phase 4	2006-11-01	The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.
NCT00807014 ↗	Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne	Completed	Stiefel, a GSK Company	Phase 4	2006-11-01	The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.
NCT00160394 ↗	Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris	Completed	GlaxoSmithKline	Phase 4	2004-12-01	Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
NCT00160394 ↗	Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris	Completed	Stiefel, a GSK Company	Phase 4	2004-12-01	Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.

Clinical Trial Conditions for benzoyl peroxide; clindamycin phosphate

Condition Name

Condition Name for benzoyl peroxide; clindamycin phosphate
Intervention	Trials
Acne Vulgaris	10
Acne	1
Actinic Keratosis	1

Condition MeSH

Condition MeSH for benzoyl peroxide; clindamycin phosphate
Intervention	Trials
Acne Vulgaris	11
Keratosis, Actinic	1
Keratosis	1

Clinical Trial Locations for benzoyl peroxide; clindamycin phosphate

Trials by Country

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Trials by Country for benzoyl peroxide; clindamycin phosphate
Location	Trials
United States	13
India	10
China	9
United Kingdom	1
Poland	1

Trials by US State

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−

Trials by US State for benzoyl peroxide; clindamycin phosphate
Location	Trials
New York	3
Pennsylvania	2
Texas	1
New Mexico	1
Nebraska	1

Clinical Trial Progress for benzoyl peroxide; clindamycin phosphate

Clinical Trial Phase

Clinical Trial Phase for benzoyl peroxide; clindamycin phosphate
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for benzoyl peroxide; clindamycin phosphate
Clinical Trial Phase	Trials
Completed	10
Unknown status	2

Clinical Trial Sponsors for benzoyl peroxide; clindamycin phosphate

Sponsor Name

Sponsor Name for benzoyl peroxide; clindamycin phosphate
Sponsor	Trials
GlaxoSmithKline	5
Stiefel, a GSK Company	4
Zeichner, Joshua, M.D.	2

Sponsor Type

Sponsor Type for benzoyl peroxide; clindamycin phosphate
Sponsor	Trials
Industry	16
Other	3

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE: Clinical Trials Update, Market Analysis, and Projections

Introduction

The combination of benzoyl peroxide and clindamycin phosphate, often used in conjunction with adapalene, has been a significant focus in the treatment of acne vulgaris. This article provides an update on the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Update

Efficacy and Safety

Recent clinical trials have demonstrated the efficacy and safety of the triple-combination gel formulation, IDP-126, which includes adapalene, benzoyl peroxide, and clindamycin phosphate. A phase II, double-blind, multicenter, randomized study involving 741 participants showed that IDP-126 achieved superior efficacy compared to vehicle and dyad component gels. At week 12, 52.5% of participants treated with IDP-126 achieved treatment success, defined as a ≥ 2-grade reduction from baseline in the Evaluator's Global Severity Score and clear/almost clear skin[4].

Tolerability and Adverse Events

The trials indicated that IDP-126 was well tolerated, with most treatment-emergent adverse events being of mild-to-moderate severity. Transient increases in scaling, erythema, itching, burning, and stinging were observed but resolved by week 12[1][4].

Mechanism of Action

Clindamycin phosphate acts by targeting the 23S RNA subunit of the bacterial ribosome, while benzoyl peroxide is an antimicrobial agent that also has a comedolytic effect. Adapalene, a naphthoic acid derivative, targets specific retinoic acid nuclear receptors (gamma and beta) and retinoid X receptors, contributing to its anti-acne properties[3].

Market Analysis

Current Market Size

The global market for clindamycin phosphate and benzoyl peroxide was estimated to be worth US$ 214 million in 2023. This market is driven by the increasing prevalence of acne vulgaris, rising awareness about skincare, and the efficacy of these treatments[5].

Key Players

Top-tier players in this market include Bausch Health, Perrigo, Mylan, Tolmar, TARO, and GSK. These companies are investing in novel formulations, enhanced drug delivery systems, and combination therapies to maintain market dominance[2][5].

Market Segments

The market is segmented into topical formulations, which are expected to maintain dominance due to ease of use and efficacy. Combination therapies, such as pairing clindamycin with other antimicrobials, are also gaining traction[2].

Regional Market

North America, particularly the United States, is the largest market due to the high prevalence of acne and strong consumer demand. The U.S. accounts for over 50% of the revenue in the North American market[2].

Market Projections

Growth Rate

The global market for clindamycin phosphate and benzoyl peroxide is forecasted to grow at a CAGR of 6.2% from 2024 to 2030, reaching a value of US$ 322.8 million by 2030[5].

Future Trends

The market is expected to be driven by innovative formulations such as microspheres and nanoparticles, which enhance drug delivery. Targeted therapies and controlled release systems are also anticipated to play a significant role in the future[2].

Regulatory Impact

Stringent approval processes for new formulations and safety concerns over prolonged use of benzoyl peroxide will continue to influence the market. However, government incentives for research and development are expected to support innovation in this sector[2].

Product Insights

Formulations

Topical lotions, gels, and creams are the primary formulations available. The use of microspheres or nanoparticles for enhanced delivery is becoming more prevalent. Combinations with other antimicrobials like erythromycin or tretinoin are also being explored[2].

End User Concentration

There is a high concentration of demand among teenagers and young adults, but there is also an increasing demand from adults with persistent acne. This broadens the potential market for these treatments[2].

Key Takeaways

• Clinical Trials: The triple-combination gel IDP-126 has shown superior efficacy and tolerability in treating acne vulgaris.
• Market Size: The global market was valued at US$ 214 million in 2023 and is projected to reach US$ 322.8 million by 2030.
• Growth Rate: The market is expected to grow at a CAGR of 6.2% from 2024 to 2030.
• Key Players: Bausch Health, Perrigo, Mylan, Tolmar, TARO, and GSK are the major players.
• Regional Market: North America, particularly the U.S., dominates the market due to high prevalence and strong consumer demand.

FAQs

What is the mechanism of action of the combination of benzoyl peroxide and clindamycin phosphate?

The combination works through multiple mechanisms: clindamycin phosphate targets the 23S RNA subunit of bacterial ribosomes, while benzoyl peroxide acts as an antimicrobial agent and has comedolytic effects. When combined with adapalene, it also targets retinoic acid nuclear receptors[3].

Which companies are the main players in this market?

The main players include Bausch Health, Perrigo, Mylan, Tolmar, TARO, and GSK[2][5].

What is the projected market size for clindamycin phosphate and benzoyl peroxide by 2030?

The market is forecasted to reach US$ 322.8 million by 2030, growing at a CAGR of 6.2% from 2024 to 2030[5].

What are the key segments driving the market?

Topical formulations and combination therapies are the key segments driving the market. Novel formulations such as microspheres and nanoparticles are also gaining traction[2].

What are the primary regions driving the demand for these treatments?

North America, particularly the United States, is the largest market due to the high prevalence of acne and strong consumer demand[2].

What are the potential safety concerns associated with prolonged use of benzoyl peroxide?

Prolonged use of benzoyl peroxide can raise safety concerns, which are being closely monitored by regulatory bodies. However, current clinical trials indicate that the combination with clindamycin phosphate and adapalene is well tolerated[2][4].

Sources

1. Patsnap Synapse: Adapalene/Benzoyl Peroxide/Clindamycin - Patsnap Synapse.
2. Data Insights Market: Drivers of Change in Clindamycin Phosphate and Benzoyl Peroxide.
3. GlobalData: Net Present Value Model: (Adapalene + Benzoyl Peroxide + Clindamycin Phosphate).
4. PubMed: Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.1%/Adapalene 0.15% Gel for the Treatment of Acne.
5. Valuates Reports: Clindamycin Phosphate and Benzoyl Peroxide - Market Size.