CLINICAL TRIALS PROFILE FOR COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

All Clinical Trials for collagenase clostridium histolyticum

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02249052 ↗	Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma	Completed	Advance Biofactures Corporation	Phase 2	2014-08-01	The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
NCT01776892 ↗	Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease	Withdrawn	University of Alberta	Phase 3	2013-05-01	Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily activities. Treatment traditionally involves cutting out diseased tissue, however this can cause damage to important structures in the hand and results in large scars. Needle aponeurotomy and collagenase injections are newer treatments that are thought to be safer. These treatments allow quicker return to function. One drawback is that Dupuytren's deformity may return more quickly than when all diseased tissue is surgically cut out. This research study is designed to compare the effectiveness of needle aponeurotomy and collagenase injection for Dupuytren's disease. This study will determine which procedure gives the best results- either needle aponeurotomy, collagenase injection, or both procedures in combination. Participants will be evaluated to see how they do in the long term.
NCT01588353 ↗	Collagenase Option for Reduction of Dupuytren's Contracture in Japan	Completed	Asahi Kasei Pharma Corporation	Phase 3	2012-05-01	To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture. To determine plasma concentration after the first injection of AK160 in patients with Dupuytren's Contracture.
NCT01613313 ↗	A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma	Completed	Advance Biofactures Corporation	Phase 2	2012-05-01	The purpose of this research is to evaluate the safest and most effective dose of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of varying sizes that occur commonly in the adult population). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it.
NCT01613313 ↗	A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma	Completed	Zachary Gerut	Phase 2	2012-05-01	The purpose of this research is to evaluate the safest and most effective dose of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of varying sizes that occur commonly in the adult population). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it.
NCT01229436 ↗	Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)	Completed	Pfizer	Phase 3	2010-12-01	This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).
NCT00261209 ↗	Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand	Completed	Stony Brook University	Phase 1/Phase 2	2005-01-01	The purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.

Clinical Trial Conditions for collagenase clostridium histolyticum

Condition Name

Condition Name for collagenase clostridium histolyticum
Intervention	Trials
Peyronie Disease	4
Dupuytren Contracture	4
Cellulite	3
Dupuytren's Contracture	2

Condition MeSH

Condition MeSH for collagenase clostridium histolyticum
Intervention	Trials
Dupuytren Contracture	8
Penile Induration	7
Contracture	6
Cellulite	3

Clinical Trial Locations for collagenase clostridium histolyticum

Trials by Country

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−

Trials by Country for collagenase clostridium histolyticum
Location	Trials
United States	23
Finland	6
Spain	3
Canada	3
Italy	2

Trials by US State

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−

Trials by US State for collagenase clostridium histolyticum
Location	Trials
Florida	7
New York	6
Minnesota	2
Utah	2
Arizona	1

Clinical Trial Progress for collagenase clostridium histolyticum

Clinical Trial Phase

Clinical Trial Phase for collagenase clostridium histolyticum
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	4
Phase 2	8

Clinical Trial Status

Clinical Trial Status for collagenase clostridium histolyticum
Clinical Trial Phase	Trials
Completed	9
Recruiting	6
Unknown status	3

Clinical Trial Sponsors for collagenase clostridium histolyticum

Sponsor Name

Sponsor Name for collagenase clostridium histolyticum
Sponsor	Trials
Endo Pharmaceuticals	8
Advance Biofactures Corporation	3
Charitable Union for the Research and Education of Peyronie's Disease	2

Sponsor Type

Sponsor Type for collagenase clostridium histolyticum
Sponsor	Trials
Other	31
Industry	14

Collagenase Clostridium Histolyticum: Clinical Trials, Market Analysis, and Projections

Introduction

Collagenase Clostridium histolyticum (CCH), marketed as Xiaflex®, is a revolutionary injectable therapeutic agent that enzymatically degrades collagen. This enzyme has been pivotal in the treatment of various conditions, including Dupuytren’s contracture and Peyronie’s disease. Here, we delve into the latest clinical trials, market analysis, and future projections for this drug.

Mechanism of Action

CCH works by enzymatically digesting type I and III collagens, suppressing fibroblast adhesion and proliferation, and decreasing the expression of structural proteins such as transforming growth factor-β1 (TGF-β1), smooth muscle actin, and fibronectin. This mechanism is crucial in treating conditions characterized by excessive collagen deposition[1].

Clinical Trials Update

Peyronie’s Disease

CCH was first applied in clinical trials for Peyronie’s disease (PD) in 1982 and gained FDA approval in 2013 for the treatment of PD in men with dorsal or lateral penile curvature greater than 30 degrees and/or with a tangible penile scar tissue plaque. The IMPRESS trials, two double-blinded, placebo-controlled phase 3 studies, demonstrated the safety and efficacy of CCH in reducing penile curvature and improving patient symptoms[1].

A recent randomized-controlled trial compared CCH with surgery for the management of PD. This study randomized patients to either CCH plus penile traction therapy (PTT) or surgery plus PTT. The results indicated a preference for CCH as a first-line treatment due to its efficacy and lower invasiveness compared to surgery[3].

Other Conditions

In addition to PD, CCH is being explored for other conditions. A prospective, open-label phase 2 clinical trial for the treatment of Dupuytren’s contracture with CCH was recently completed, and results are expected to provide further guidance on its clinical use[1].

Market Analysis

Current Market Size and Growth

The global collagenase Clostridium histolyticum market was valued at USD 420.2 million in 2023 and is projected to reach USD 680.5 million by 2031, growing at a CAGR of 4.8% from 2024 to 2031. This growth is driven by the increasing incidence of diseases such as Peyronie’s disease and Dupuytren’s contracture, as well as the expanding use of collagenase in cosmetic and medical procedures[2].

Regional Market Trends

North America is expected to dominate the global market due to high awareness about diseases like Peyronie’s and the presence of advanced clinical facilities in the US and Canada. Europe is also anticipated to witness significant growth due to its well-developed healthcare infrastructure. In contrast, regions like the Middle East, Africa, and Latin America are expected to see slower growth due to limited awareness and fewer established market players[4].

Competitive Landscape

The market is highly competitive, with several well-established players. The XIAFLEX medication segment is expected to contribute significantly to the market growth due to its widespread use in treating Peyronie’s disease and Dupuytren’s contracture[4].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Target Diseases: The rising incidence of Peyronie’s disease and Dupuytren’s contracture is a key driver for the market.
• Growing Acceptance of Minimally Invasive Procedures: The preference for minimally invasive treatments over surgical options is boosting the demand for CCH.
• Advancements in Biotechnology: Continuous research aimed at improving the safety and efficacy of CCH is driving market expansion[2][4].

Challenges

• Awareness and Education: Limited awareness in developing economies hampers market growth.
• Regulatory Approvals: The need for rigorous clinical trials and regulatory approvals can slow down market entry in new regions.
• Competitive Market: The presence of multiple players in the market can lead to intense competition, affecting market share[4].

Future Projections

Expanding Applications

CCH is expected to find applications in various medical areas, including wound care, pain management, and burn management, due to its tissue remodeling capabilities[4].

Clinical Research

Ongoing and future clinical trials will continue to provide evidence on the efficacy and safety of CCH, potentially expanding its indications and improving treatment outcomes. For example, a recent study found significant improvements in penile curvature deformity after CCH injections, further solidifying its position in treating PD[5].

Market Growth

The market is anticipated to grow steadily, driven by increasing awareness, advancements in biotechnology, and the growing acceptance of minimally invasive treatments. Government initiatives and awareness campaigns are also expected to bolster the market in the coming years[2][4].

Key Takeaways

• Clinical Efficacy: CCH has demonstrated significant efficacy in treating Peyronie’s disease and Dupuytren’s contracture.
• Market Growth: The global market for CCH is expected to grow at a CAGR of 4.8% from 2024 to 2031.
• Regional Trends: North America and Europe are expected to be the dominant regions, while Asia Pacific and other regions will see moderate to slow growth.
• Market Drivers: Increasing disease prevalence, growing acceptance of minimally invasive procedures, and biotechnology advancements are key drivers.
• Future Applications: CCH is expected to expand into other medical areas such as wound care and burn management.

FAQs

What is Collagenase Clostridium Histolyticum (CCH)?

CCH is an injectable therapeutic agent that enzymatically degrades collagen, used primarily in the treatment of Peyronie’s disease and Dupuytren’s contracture.

What are the key applications of CCH?

CCH is used to treat Peyronie’s disease and Dupuytren’s contracture, and it is also being explored for use in wound care, pain management, and burn management.

What are the results of the IMPRESS trials for CCH?

The IMPRESS trials demonstrated the safety and efficacy of CCH in reducing penile curvature and improving patient symptoms in men with Peyronie’s disease.

How is the market for CCH expected to grow?

The global market for CCH is expected to reach USD 680.5 million by 2031, growing at a CAGR of 4.8% from 2024 to 2031.

What are the main drivers of the CCH market?

The main drivers include the increasing prevalence of target diseases, growing acceptance of minimally invasive procedures, and advancements in biotechnology.

Sources

1. Natale, C., & Hellstrom, W. J. G. (2021). Update on Future Applications and Potential Use of Xiaflex/Collagenase. AUA News.
2. Market Research Intellect. (n.d.). Collagenase Clostridium Histolyticum Market Size And Forecast.
3. Trost, L., & Jenkins, T. (2020). Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie’s Disease: A Randomized Trial.
4. Transparency Market Research. (n.d.). Collagenase Clostridium Histolyticum Market Survey Report 2031.
5. Frontiers in Medicine. (2022). Efficacy and Safety of Collagenase Clostridium Histolyticum in the Treatment of Peyronie’s Disease.