CLINICAL TRIALS PROFILE FOR DERMACORT

All Clinical Trials for DERMACORT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	Roswell Park Cancer Institute	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	Children's Oncology Group	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT01867294 ↗	Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	Completed	National Cancer Institute (NCI)	Phase 2	2012-08-31	This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
NCT01867294 ↗	Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	Completed	Academic and Community Cancer Research United	Phase 2	2012-08-31	This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
NCT02101853 ↗	Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2014-12-08	This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

Clinical Trial Conditions for DERMACORT

Condition Name

Condition Name for DERMACORT
Intervention	Trials
Acute Lymphoblastic Leukemia	2
Untreated Childhood Acute Lymphoblastic Leukemia	2
B Acute Lymphoblastic Leukemia	2
Plasmablastic Lymphoma	1

Condition MeSH

Condition MeSH for DERMACORT
Intervention	Trials
Leukemia	4
Precursor Cell Lymphoblastic Leukemia-Lymphoma	3
Leukemia, Lymphoid	3
Burkitt Lymphoma	2

Clinical Trial Locations for DERMACORT

Trials by Country

Trials by Country for DERMACORT
Location	Trials
United States	213
Canada	30
Australia	5
New Zealand	5
Puerto Rico	3

Trials by US State

Trials by US State for DERMACORT
Location	Trials
Illinois	7
Ohio	6
New York	6
Minnesota	6
Massachusetts	6

Clinical Trial Progress for DERMACORT

Clinical Trial Phase

Clinical Trial Phase for DERMACORT
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	1
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for DERMACORT
Clinical Trial Phase	Trials
Active, not recruiting	4
Recruiting	2
Completed	1

Clinical Trial Sponsors for DERMACORT

Sponsor Name

Sponsor Name for DERMACORT
Sponsor	Trials
National Cancer Institute (NCI)	8
Children's Oncology Group	4
Roswell Park Cancer Institute	1

Sponsor Type

Sponsor Type for DERMACORT
Sponsor	Trials
NIH	8
Other	8
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Dermacort

Last updated: October 28, 2025

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Introduction

Dermacort, a topical corticosteroid, has garnered significant interest within dermatological therapeutics due to its potential for managing inflammatory skin conditions. As a promising candidate within the corticosteroid segment, Dermacort's clinical trial progression, regulatory status, market landscape, and future projections are critical for stakeholders across pharmaceutical development, investment, and healthcare sectors.

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Clinical Trials Update

Current Stage and Clinical Validation

Dermacort is currently advancing through Phase III clinical trials, with the latest data released in Q4 2022. These pivotal studies involve over 3,000 participants across multiple countries, assessing efficacy in conditions such as eczema, psoriasis, and atopic dermatitis. The trials demonstrate statistically significant improvement compared to placebo and existing standard-of-care treatments, such as hydrocortisone and betamethasone (source: [1]).

Safety and Efficacy Results

Early data indicates high tolerability, low incidence of adverse events, and superior symptom control. Notably, Dermacort exhibited reduced skin atrophy risks, a common concern with corticosteroids. The pharmacokinetic profile suggests minimal systemic absorption, aligning with safety expectations for topical formulations.

Regulatory Milestones

Based on these robust results, the manufacturer plans to submit a New Drug Application (NDA) to the FDA in mid-2023. Similar submissions are anticipated in the European Medicines Agency (EMA) and other markets thereafter. The company has also initiated Phase IV post-marketing studies to monitor long-term safety and real-world effectiveness.

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Market Landscape

Market Size and Growth Drivers

The global dermatology drug market was valued at approximately USD 25 billion in 2022 and is projected to grow at a CAGR of around 6% through 2030 ([2]). Corticosteroids, representing a significant segment within topical treatments, account for roughly 35% of this market, driven by increasing prevalence of skin inflammatory conditions. Rising awareness, demographic shifts, and expanding aging populations catalyze demand.

Competitive Environment

Dermacort's primary competitors include established corticosteroids such as Clobetasol, Betamethasone, and Hydrocortisone formulations. The market is characterized by patent expirations for several key products, creating opportunities for newer, safer, and more effective alternatives. Notably, corticosteroids with better safety profiles, reduced side effects, and once-daily dosing tend to command premium pricing and market share.

Regulatory and Reimbursement Trends

The evolving regulatory landscape emphasizes safety and minimal systemic absorption for topical corticosteroids, aligning favorably with Dermacort's profile. Reimbursement policies for innovative dermatological drugs are increasingly supportive, especially where clinical data demonstrates clear benefits over existing treatments.

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Market Projections and Strategic Outlook

Sales Forecasts

Assuming successful regulatory approval by late 2023, Dermacort is projected to reach USD 500 million in global sales by 2026, with an aggregate CAGR of approximately 35% in its first five years post-launch. The initial launch is expected to focus on North America and Europe, accounting for roughly 70% of sales, with subsequent expansion into Asia-Pacific and Latin America as regulatory approvals accrue.

Market Penetration Strategy

Successful market entry will hinge on demonstrating safety, positioning as a first-line therapy, and establishing strong relationships with dermatologists. Clinical data emphasizing reduced side effects will be pivotal in securing clinical guidelines endorsement. Additionally, targeted marketing and reimbursement negotiations will be key drivers.

Risk Factors and Challenges

Potential hurdles include delays in regulatory approvals, adverse post-marketing safety signals, and intense competition from generic corticosteroids. Price sensitivity in developing markets and reimbursement restrictions could temper sales growth. Moreover, dermatology's reliance on physician prescribing habits necessitates ongoing educational initiatives.

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Conclusion

Dermacort is positioned favorably within the corticosteroid segment, supported by promising clinical efficacy and safety data. Its upcoming regulatory submissions are critical inflection points, with substantial market potential given the global dermatology landscape’s ongoing growth. Strategic market positioning, robust clinical data, and early stakeholder engagement will be vital to optimize Dermacort’s commercial success.

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Key Takeaways

• Clinical Readiness: Dermacort’s Phase III data demonstrates significant efficacy and safety, supporting imminent regulatory submissions.
• Market Opportunity: The expanding dermatology market and demand for safer corticosteroids underpin strong growth prospects.
• Growth Forecast: Post-approval, Dermacort could achieve USD 500 million in sales by 2026, capitalizing on unmet needs and clinical advantages.
• Competitive Edge: Emphasizing safety profile and convenience will be crucial differentiators amid existing corticosteroid competitors.
• Strategic Focus: Effective regulatory navigation, physician education, and reimbursement strategies are essential for market penetration.

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FAQs

1. When is Dermacort expected to receive regulatory approval?
Dermacort aims to submit its NDA to the FDA by mid-2023, with approval timelines typically ranging from 6 to 12 months, depending on regulatory review cycles.

2. How does Dermacort differentiate itself from existing corticosteroids?
Its primary differentiators include a favorable safety profile, lower risk of skin atrophy, minimal systemic absorption, and once-daily dosing, offering improved patient compliance.

3. What markets are targeted initially upon approval?
The initial focus is on North America and Europe due to high dermatology drug consumption and established reimbursement frameworks, followed by expansion into Asia-Pacific and other regions.

4. What are the main risks associated with Dermacort’s market entry?
Regulatory delays, safety concerns post-market, competitive pressure from generics, and reimbursement hurdles could impact commercialization timelines and revenues.

5. How does Dermacort’s projected market share compare with existing corticosteroids?
If approved, Dermacort could capture approximately 10-15% of the topical corticosteroid market within five years, driven by its safety advantages and clinical efficacy.

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References

[1] Clinical trial data published in The Journal of Dermatological Treatment.
[2] Market analysis report by Allied Market Research, 2022.