CLINICAL TRIALS PROFILE FOR HYDROCORTISONE ACETATE; UREA

All Clinical Trials for Hydrocortisone Acetate; Urea

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00915343 ↗	Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency	Completed	Shire	Phase 2/Phase 3	2007-08-21	This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency
NCT01014364 ↗	Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu	Terminated	Assistance Publique - Hôpitaux de Paris	Phase 3	2010-03-01	The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.
NCT01014364 ↗	Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu	Terminated	University of Versailles	Phase 3	2010-03-01	The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.

Clinical Trial Conditions for Hydrocortisone Acetate; Urea

Condition Name

Condition Name for Hydrocortisone Acetate; Urea
Intervention	Trials
Congenital Adrenal Hyperplasia	2
Internal Hemorrhoids	2
Adrenal Insufficiency	2

Condition MeSH

Condition MeSH for Hydrocortisone Acetate; Urea
Intervention	Trials
Adrenogenital Syndrome	4
Adrenal Hyperplasia, Congenital	4
Hemorrhoids	3

Clinical Trial Locations for Hydrocortisone Acetate; Urea

Trials by Country

Trials by Country for Hydrocortisone Acetate; Urea
Location	Trials
United States	18
China	4
Norway	2
India	1
France	1

Trials by US State

Trials by US State for Hydrocortisone Acetate; Urea
Location	Trials
Michigan	4
California	3
Texas	3
New York	2
Maryland	2

Clinical Trial Progress for Hydrocortisone Acetate; Urea

Clinical Trial Phase

Clinical Trial Phase for Hydrocortisone Acetate; Urea
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Hydrocortisone Acetate; Urea
Clinical Trial Phase	Trials
Completed	10
Unknown status	5
Recruiting	2

Clinical Trial Sponsors for Hydrocortisone Acetate; Urea

Sponsor Name

Sponsor Name for Hydrocortisone Acetate; Urea
Sponsor	Trials
Children's Hospital Los Angeles	2
Feinstein Institute for Medical Research	2
University of Michigan	2

Sponsor Type

Sponsor Type for Hydrocortisone Acetate; Urea
Sponsor	Trials
Other	20
Industry	11
NIH	2

Hydrocortisone Acetate and Urea: Clinical Trials, Market Analysis, and Projections

Introduction

Hydrocortisone acetate, a potent corticosteroid, and urea, a moisturizing agent, are commonly used in various dermatological and gastrointestinal treatments. This article provides an update on the clinical trials, market analysis, and projections for these compounds.

Clinical Trials Update

Hydrocortisone Acetate in Ulcerative Colitis

A recent pivotal Phase 3 trial conducted by Cristcot has shown promising results for the use of hydrocortisone acetate suppositories in treating ulcerative colitis (UC) of the rectum. The trial, known as the cessa trial, evaluated the safety and efficacy of a 90-milligram hydrocortisone acetate suppository administered with the Sephure® suppository applicator.

• Key Findings: The trial demonstrated that patients achieved clinical remission by Day 29, with significant symptom relief observed as early as Day 15. The treatment was well-tolerated, with no adverse events of statistical significance reported. High compliance rates were noted, with 97% compliance for the once-daily regimen[3].

Hydrocortisone Acetate in Dermatological Conditions

For dermatological conditions, hydrocortisone acetate is often used in topical formulations. A study on the percutaneous penetration of hydrocortisone acetate with urea highlighted that the addition of urea to the cream vehicle increased the penetration of hydrocortisone acetate approximately twofold[4].

EUCRISA and Hydrocortisone Acetate Comparison

While not directly comparing hydrocortisone acetate to EUCRISA (crisaborole), it's worth noting that EUCRISA, another topical treatment for atopic dermatitis, has shown efficacy in clinical trials. However, hydrocortisone acetate remains a staple in treating various skin conditions due to its broad applicability and well-characterized safety profile[1].

Market Analysis

Global Hydrocortisone Cream Market

The global hydrocortisone cream market is projected to grow significantly over the next few years. Here are some key market insights:

• Market Size: The global hydrocortisone cream market size was estimated at USD 1352.2 million in 2024 and is expected to expand to USD 2101.3 million by 2031, with a Compound Annual Growth Rate (CAGR) of 6.50% from 2024 to 2031[2].

• Regional Breakdown: North America currently dominates the market, holding more than 40% of the global revenue with a market size of USD 540.88 million in 2024. Europe and Asia-Pacific also hold significant market shares, with CAGRs of 5.0% and 8.5%, respectively, from 2024 to 2031[2].

• Growth Drivers: The increasing incidence of cutaneous conditions, sophisticated healthcare infrastructure, and growing consumer awareness of skin health are key drivers of this market growth[2].

Hydrocortisone Market Overview

The broader hydrocortisone market, including all formulations, is also expected to grow due to several factors:

• Adrenocortical Insufficiency: The rise in cases of adrenocortical insufficiency and other conditions requiring hydrocortisone replacement therapy is driving the market. The global hydrocortisone market was valued at US$ 1.25 billion in 2019 and is anticipated to expand at a CAGR of ~4% from 2020 to 2028[5].

• Research and Development: Increased investment in research and development is further propelling the market growth, as new formulations and delivery methods are being explored[5].

Projections and Future Outlook

Hydrocortisone Acetate Suppositories

Given the positive Phase 3 results for hydrocortisone acetate suppositories in treating ulcerative colitis, Cristcot is on track for an NDA submission in Q1 2025. If approved, this novel therapy is expected to significantly impact the treatment paradigm for UC, offering rapid symptom relief and clinical remission within a shorter timeframe compared to current therapies[3].

Topical Hydrocortisone Creams

The topical hydrocortisone cream market is projected to continue its growth trajectory, driven by the increasing prevalence of skin conditions and the need for effective, easily accessible treatments. The addition of urea to hydrocortisone creams is likely to remain a popular formulation due to its enhanced penetration and moisturizing benefits[2][4].

Emerging Markets

Emerging economies such as China and India are expected to contribute significantly to the growth of the hydrocortisone market. Improved healthcare expenditure, better access to healthcare services, and growing consumer awareness of skin health are key factors driving this growth[2].

Key Takeaways

• Clinical Trials: Hydrocortisone acetate suppositories have shown promising results in treating ulcerative colitis, with high compliance rates and significant symptom relief.
• Market Growth: The global hydrocortisone cream market is expected to grow at a CAGR of 6.50% from 2024 to 2031, driven by increasing skin condition prevalence and improved healthcare infrastructure.
• Regional Dominance: North America currently leads the hydrocortisone cream market, but Asia-Pacific is expected to grow at the highest CAGR.
• Future Outlook: New formulations and delivery methods, such as suppositories, are poised to transform the treatment landscape for conditions like ulcerative colitis.

FAQs

What are the key findings from the Phase 3 trial of hydrocortisone acetate suppositories for ulcerative colitis?

The Phase 3 trial demonstrated that patients achieved clinical remission by Day 29, with significant symptom relief observed as early as Day 15. The treatment was well-tolerated, and high compliance rates were noted[3].

How does the addition of urea affect the penetration of hydrocortisone acetate in topical creams?

The addition of urea to hydrocortisone acetate creams increases the penetration of hydrocortisone acetate approximately twofold[4].

What is the projected market size of the global hydrocortisone cream market by 2031?

The global hydrocortisone cream market is expected to reach USD 2101.3 million by 2031, growing at a CAGR of 6.50% from 2024 to 2031[2].

Which regions are expected to drive the growth of the hydrocortisone cream market?

North America, Europe, and Asia-Pacific are expected to be significant drivers of the market growth, with Asia-Pacific having the highest CAGR[2].

What are the primary drivers of the global hydrocortisone market growth?

The rise in cases of adrenocortical insufficiency, increasing incidence of cutaneous conditions, and increased investment in research and development are key drivers of the market growth[2][5].

Sources

1. FDA Clinical Review and Evaluation: Clinical Review and Evaluation - FDA.
2. Cognitive Market Research: Global Hydrocortisone Cream Market Report.
3. BioSpace: Cristcot Announces Positive Phase 3 Results for Novel Hydrocortisone Acetate Suppository.
4. JAMA Network: Percutaneous Penetration of Hydrocortisone With Urea.
5. BioSpace: Hydrocortisone Market to Reach a Value of US$2 Bn by 2028.