CLINICAL TRIALS PROFILE FOR SANTYL

All Clinical Trials for SANTYL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00651820 ↗	Effect of Collagenase on Healing and Scarring	Completed	Healthpoint	Phase 4	2008-04-01	A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.
NCT01056198 ↗	Santyl vs. Sharp Debridement of Diabetic Foot Wounds	Completed	Healthpoint	Phase 4	2010-02-01	This study tests two different approaches to the removal of dead tissue from the surface of a wound.
NCT01143714 ↗	A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers	Completed	Healthpoint	Phase 4	2010-06-01	The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.
NCT01143727 ↗	Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers	Completed	Healthpoint	Phase 4	2010-07-01	This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.
NCT01516463 ↗	Using Santyl or Bacitracin on Second Degree Burns	Withdrawn	Healthpoint	Phase 4	2012-03-01	Subjects who have minor, second degree burns may be enrolled in this study. Subjects will receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals. Bandages will be used to keep the burn covered while it heals. Second degree burns generally leave a scar. Once the burn heals, lotion and an appropriate bandage will be used to try to minimize the appearance of a scar. The study hypothesis is that burns treated with Santyl will have a better scar appearance than burns treated with bacitracin. Subjects enrolled in this study will make once a week visits to the University of Kansas Medical Center outpatient burn clinic until the burn heals. The burn will be assessed for healing at these visits. Once healed, visits to the clinic will be every 1-3 months for up to 1 year. At these visits, the appearance of the scar will be evaluated
NCT02131961 ↗	EZCast-DFU Study With Portal for Application of Topical Medications	Completed	University of Miami	Phase 1	2014-10-01	This study is designed to evaluate the ability to modify a contact cast system so that topical medications can be applied daily to an underlying wound in patients with diabetic plantar ulcers. The modification of the cast will be done by making an opening where the wound is located in the contact cast system. A contact cast system is a device that will reduce the pressure in the area where the wound is located.

Clinical Trial Conditions for SANTYL

Condition Name

Condition Name for SANTYL
Intervention	Trials
Diabetic Foot Ulcers	3
Burn, Partial Thickness	2
Diabetic Foot	1
Foot Ulcer	1

Condition MeSH

Condition MeSH for SANTYL
Intervention	Trials
Foot Ulcer	4
Diabetic Foot	4
Ulcer	3
Burns	2

Clinical Trial Locations for SANTYL

Trials by Country

Trials by Country for SANTYL
Location	Trials
United States	14

Trials by US State

Trials by US State for SANTYL
Location	Trials
Texas	4
Florida	2
Pennsylvania	2
Kansas	1
Massachusetts	1

Clinical Trial Progress for SANTYL

Clinical Trial Phase

Clinical Trial Phase for SANTYL
Clinical Trial Phase	Trials
Phase 4	6
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for SANTYL
Clinical Trial Phase	Trials
Completed	5
Withdrawn	1
Recruiting	1

Clinical Trial Sponsors for SANTYL

Sponsor Name

Sponsor Name for SANTYL
Sponsor	Trials
Healthpoint	6
University of Miami	1
Derma Sciences, Inc.	1

Sponsor Type

Sponsor Type for SANTYL
Sponsor	Trials
Industry	8
Other	2

SANTYL Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for SANTYL

Introduction to SANTYL

SANTYL Ointment, containing collagenase, is a widely used enzymatic debridement agent approved by the FDA for debriding chronic dermal ulcers and severely burned areas. Here, we will delve into recent clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Recent Comparative Studies

A recent head-to-head comparison study between SANTYL and MediWound's EscharEx in the ChronEx Phase II randomized controlled study revealed significant differences in efficacy. Here are the key findings:

• Complete Debridement: EscharEx showed a 63.0% incidence of complete debridement during the first two weeks, whereas SANTYL achieved 0% during the same period[1][3].
• Time to Debridement: The median time to achieve complete debridement was 9 days for EscharEx, compared to not being achieved for SANTYL[1][3].
• Wound Bed Preparation (WBP): EscharEx achieved WBP in 50.0% of patients during the daily treatment period, while SANTYL did not achieve WBP in any patients during this period[1][3].
• Wound Closure: EscharEx resulted in complete wound closure in 32.6% of patients, with an average time to closure of 48.4 days, compared to 25% for SANTYL with an average time of 76.0 days[1][3].

Efficacy in Various Wound Types

Despite the comparative disadvantages against EscharEx, SANTYL has shown efficacy in various clinical settings:

• Pressure Ulcers: A study showed that pressure ulcers treated with SANTYL achieved faster rates of granulation and epithelialization compared to medicinal honey treatment. Patients treated with SANTYL were 38% more likely to achieve 100% granulation and 47% more likely to achieve epithelialization at one year[5].
• Burns and Traumatic Injuries: Case studies have demonstrated SANTYL's effectiveness in treating burns, traumatic injuries, and other types of wounds, including significant reductions in wound area and establishment of granulation tissue[4].

Market Analysis

Current Market Position

SANTYL is currently the market-leading enzymatic debridement product, with estimated annual sales of over $360 million in the United States. It is widely recognized and used for its selective removal of necrotic tissue without harming granulation tissue[1].

Market Segmentation

The collagenase market, which includes SANTYL, is segmented by disease type, medicine type, and geography. Key segments include:

• Disease Type: Cellulite, penile fibrosis/Peyronie’s disease, Dupuytren’s contracture, and others.
• Medicine Type: SANTYL Ointment and other collagenase products like XIAFLEX.
• Geography: North America, Europe, Asia-Pacific, South America, and the Rest of the World. North America holds the largest share, driven by the prevalence of conditions like Dupuytren's contracture and penile fibrosis[2].

Market Size and Growth

The collagenase market, including SANTYL, is projected to grow at a CAGR of 3.20% from 2024 to 2030, reaching a market size of $725.93 million by 2030. This growth is driven by the increasing prevalence of conditions such as Dupuytren's contracture and penile fibrosis, particularly in the aging population[2].

Future Projections

Competitive Landscape

The emergence of new products like EscharEx from MediWound poses a significant challenge to SANTYL's market dominance. EscharEx has shown superior efficacy in several clinical outcome measures, which could potentially shift market share in the future[1][3].

Regulatory and Clinical Developments

SANTYL's continued use and market position will depend on ongoing clinical trials and regulatory approvals. While EscharEx is set to begin Phase III trials in the second half of 2024, SANTYL will need to maintain its clinical efficacy and safety profile to remain competitive[1][3].

Market Trends

The aging population and increasing prevalence of chronic wounds are expected to drive demand for enzymatic debridement agents. However, the market will be influenced by the performance of new entrants like EscharEx and any changes in regulatory or reimbursement landscapes[2].

Key Takeaways

• Clinical Efficacy: SANTYL has shown efficacy in treating various types of wounds, but recent studies suggest it may be outperformed by newer agents like EscharEx.
• Market Position: SANTYL is currently the market leader in enzymatic debridement, but faces competition from emerging products.
• Market Growth: The collagenase market is expected to grow, driven by increasing prevalence of related conditions, particularly in the aging population.
• Future Challenges: SANTYL must maintain its clinical and safety profile to remain competitive against new products.

FAQs

What is SANTYL used for?

SANTYL Ointment is used for debriding chronic dermal ulcers and severely burned areas. It selectively removes necrotic tissue without harming granulation tissue[5].

How does SANTYL compare to EscharEx in clinical trials?

Recent head-to-head studies have shown that EscharEx outperforms SANTYL in several clinical outcome measures, including complete debridement, time to debridement, and wound bed preparation[1][3].

What is the current market size of SANTYL?

SANTYL has estimated annual sales of over $360 million in the United States and is a significant player in the global collagenase market[1].

What are the key drivers of the collagenase market growth?

The market growth is driven by the increasing prevalence of conditions like Dupuytren's contracture and penile fibrosis, particularly in the aging population[2].

Are there any upcoming clinical trials or regulatory developments for SANTYL?

While there are no specific upcoming trials mentioned for SANTYL, the product will need to maintain its clinical efficacy and safety profile to remain competitive. EscharEx, a competing product, is set to begin Phase III trials in the second half of 2024[1][3].

Sources

1. MediWound Announces Positive Results in Head-to-Head Comparison of EscharEx® vs. SANTYL® within the ChronEx Phase II Randomized Controlled Study. MediWound Ltd., February 12, 2024.
2. Collagenase Clostridium Histolyticum Market Report, 2024-2030. Industry ARC.
3. MediWound Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update. BioSpace, March 21, 2024.
4. Patient case studies | Collagenase SANTYL Ointment for HCPs. SANTYL.
5. Smith & Nephew Inc. Release: Collagenase SANTYL Ointment Advances Pressure Ulcers Through the Healing Process Faster, New Study Suggests. BioSpace, May 4, 2017.