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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR HYDROCORTONE


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All Clinical Trials for Hydrocortone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002855 ↗ Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1996-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002855 ↗ Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer Completed M.D. Anderson Cancer Center Phase 3 1996-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00220454 ↗ Effect of Estrogen & Stress for Postmenopausal Women Completed National Alliance for Research on Schizophrenia and Depression Phase 2 2002-12-01 The study tests the hypothesis that estradiol administration exacerbates the effects of the stress hormone cortisol on cognition and mood for postmenopausal women. This randomized, placebo-controlled, double-blind study was designed to examine the effects of an eight-week trial of transdermal estradiol replacement therapy (0.10 mg/day) in combination with 4 days of oral hydrocortisone (90 mg/day in 3 daily doses of 30 mg per dose) in the last week of hormone therapy on cognition and mood in healthy postmenopausal women. Forty cognitively healthy postmenopausal women were randomized to receive either placebo or estradiol skin patches for 8 weeks. In the middle of the 7th week (day 57), subjects in each group were again randomized to receive either a placebo tablet or an oral hydrocortisone tablet 3x/day for 4 days. Memory testing and blood collection occurred at baseline, at week 4, and again at week 8.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hydrocortone

Condition Name

Condition Name for Hydrocortone
Intervention Trials
Acute Lymphoblastic Leukemia 2
Prostate Cancer 2
B Acute Lymphoblastic Leukemia 2
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Condition MeSH

Condition MeSH for Hydrocortone
Intervention Trials
Leukemia 4
Leukemia, Lymphoid 3
Prostatic Neoplasms 3
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Clinical Trial Locations for Hydrocortone

Trials by Country

Trials by Country for Hydrocortone
Location Trials
United States 217
Canada 30
Australia 5
New Zealand 5
Puerto Rico 3
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Trials by US State

Trials by US State for Hydrocortone
Location Trials
Illinois 7
Ohio 7
Texas 7
Massachusetts 7
Wisconsin 6
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Clinical Trial Progress for Hydrocortone

Clinical Trial Phase

Clinical Trial Phase for Hydrocortone
Clinical Trial Phase Trials
Phase 3 5
Phase 2 2
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Hydrocortone
Clinical Trial Phase Trials
Active, not recruiting 4
Completed 4
Recruiting 2
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Clinical Trial Sponsors for Hydrocortone

Sponsor Name

Sponsor Name for Hydrocortone
Sponsor Trials
National Cancer Institute (NCI) 9
Children's Oncology Group 4
Beth Israel Deaconess Medical Center 2
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Sponsor Type

Sponsor Type for Hydrocortone
Sponsor Trials
Other 20
NIH 10
Industry 2
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Clinical Trials, Market Analysis, and Projections for Hydrocortisone

Introduction to Hydrocortisone

Hydrocortisone, a synthetic form of the hormone cortisol, is widely used in various medical applications, including the treatment of adrenal insufficiency, skin conditions, and respiratory issues. This article will delve into the current clinical trials, market analysis, and future projections for hydrocortisone.

Clinical Trials Update

Adrenal Insufficiency Trials

One of the significant clinical trials involving hydrocortisone is the CHAMPAIN study conducted by Diurnal Group plc. This Phase 2 European clinical trial is evaluating the efficacy, safety, and tolerability of modified-release hydrocortisone (DNL-0200) in adults with adrenal insufficiency (AI). The study, which began in February 2022, aims to compare the modified-release hydrocortisone with Plenadren®, a current standard treatment. The trial is expected to complete within six months, with data readout anticipated in the second half of 2022. Positive results could lead to regulatory approval in 2023, addressing a significant market need for better treatments in AI, which represents a market opportunity of approximately $1.9 billion across Europe and the UK[1].

Market Analysis

Global Hydrocortisone Cream Market

The global hydrocortisone cream market is substantial and growing. As of 2024, the market size is estimated to be USD 1352.2 million, with a projected compound annual growth rate (CAGR) of 6.50% from 2024 to 2031. This growth is driven by the increasing incidence of cutaneous conditions such as eczema, psoriasis, and other skin allergies.

  • Regional Breakdown: North America holds the largest market share, with a market size of USD 540.88 million in 2024, followed by Europe with USD 405.66 million. The Asia Pacific region, however, is expected to grow at the highest CAGR of 8.5% during the forecast period[2].

  • Distribution Channels: The market is segmented by application, distribution channels, and end-users. Understanding these segments is crucial for identifying the most lucrative areas and future market opportunities[2].

Market Projections

Hydrocortisone Cream Market Growth

By 2031, the global hydrocortisone cream market is expected to expand to USD 2101.3 million. Here are some key projections:

  • North America: Expected to grow at a CAGR of 4.7%, reaching a significant portion of the global market share.
  • Europe: Projected to grow at a CAGR of 5.0%, maintaining its substantial market presence.
  • Asia Pacific: Anticipated to be the fastest-growing region with a CAGR of 8.5%, driven by increasing healthcare needs and favorable market conditions[2].

Clinical Trials Market Impact

The broader clinical trials market, which includes trials for hydrocortisone and other drugs, is also experiencing significant growth. Valued at $48.2 billion in 2023, the global clinical trials market is projected to reach $73.2 billion by 2028, growing at a CAGR of 8.7%. This growth is driven by increasing investments in pharmaceutical R&D and the outsourcing of clinical trial services to Contract Research Organizations (CROs)[3].

Therapeutic Areas and Applications

Adrenal Insufficiency

The use of hydrocortisone in adrenal insufficiency is a critical area of focus. The CHAMPAIN study mentioned earlier aims to improve the treatment outcomes for patients with AI by mimicking the physiological overnight rise of cortisol. Successful outcomes from this trial could significantly impact the quality of life for AI patients and open up new market opportunities[1].

Cutaneous Conditions

Hydrocortisone cream is widely used for treating various skin conditions. The increasing incidence of these conditions is a major driver for the growth of the hydrocortisone cream market. Effective marketing and distribution strategies in this segment can capitalize on the rising demand for topical treatments[2].

Respiratory Conditions

Although a study on COVID-19 patients found that low-dose hydrocortisone did not significantly reduce treatment failure in acute respiratory failure, hydrocortisone remains a valuable treatment option for other respiratory conditions. Its anti-inflammatory properties make it a staple in managing chronic respiratory diseases[4].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region is emerging as a significant hub for clinical trials and pharmaceutical development. The region's favorable government policies, large patient population, and cost-effectiveness make it an attractive destination for outsourcing clinical trial services. This trend is expected to drive the growth of the hydrocortisone market, particularly in countries like China and India[3].

North America and Europe

North America and Europe continue to be major markets for hydrocortisone products. These regions have well-established healthcare systems and a high demand for effective treatments for various conditions. The market in these regions is expected to grow steadily, driven by the increasing incidence of skin and hormonal disorders[2].

Key Takeaways

  • Clinical Trials: The CHAMPAIN study is a pivotal trial for hydrocortisone in adrenal insufficiency, with potential regulatory approvals in 2023.
  • Market Size: The global hydrocortisone cream market is projected to reach USD 2101.3 million by 2031, growing at a CAGR of 6.50%.
  • Regional Growth: Asia Pacific is expected to be the fastest-growing region, while North America and Europe maintain significant market shares.
  • Therapeutic Areas: Hydrocortisone is crucial in treating adrenal insufficiency, cutaneous conditions, and certain respiratory diseases.

FAQs

What is the current status of the CHAMPAIN clinical trial for hydrocortisone?

The CHAMPAIN clinical trial, which began in February 2022, is ongoing and expected to complete within six months, with data readout anticipated in the second half of 2022[1].

How large is the global hydrocortisone cream market?

As of 2024, the global hydrocortisone cream market size is estimated to be USD 1352.2 million[2].

What is the projected growth rate of the hydrocortisone cream market?

The global hydrocortisone cream market is expected to grow at a CAGR of 6.50% from 2024 to 2031[2].

Which region is expected to grow the fastest in the hydrocortisone cream market?

The Asia Pacific region is anticipated to be the fastest-growing region, with a CAGR of 8.5% from 2024 to 2031[2].

What are the primary therapeutic areas for hydrocortisone?

Hydrocortisone is primarily used in treating adrenal insufficiency, cutaneous conditions, and certain respiratory diseases[1][2][4].

Sources

  1. Diurnal Group plc: "First patient dosed in Phase 2 clinical trial with modified-release hydrocortisone in adults with adrenal insufficiency"[1].
  2. Cognitive Market Research: "Hydrocortisone Cream Market Report 2024 (Global Edition)"[2].
  3. MarketsandMarkets: "Clinical Trials Market Size, Share, Trends and Revenue Forecast to 2028"[3].
  4. JAMA Network: "Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support in Patients With COVID-19–Related Acute Respiratory Failure"[4].

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