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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR HYDROCORTISONE; UREA


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505(b)(2) Clinical Trials for Hydrocortisone; Urea

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00754247 ↗ A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars Completed University of Miami Phase 4 2006-03-01 Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. 0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids. This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication. You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Hydrocortisone; Urea

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001409 ↗ Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1994-09-01 Certain patients enrolled in NIH protocol 94-I-0206 at the Clinical Center may be eligible to participate in one or more of the following new options: - Donor/recipient extension phase - Both the recipient (HIV-infected twin) and donor (non-infected twin) will participate in this extension of the CD4-zeta gene therapy study. It will evaluate the safety and activity of infusing gene-modified CD4+ cells as well as the modified CD8+ cells. - Corticosteroid administration - A corticosteroid, such as prednisone, hydrocortisone or prednisolone, will be added to the interleukin-2 (IL-2) regimen for preventing or treating side effects of IL-2 such as fever and other flu-like symptoms. - Extended follow-up - A more intensive follow-up will be scheduled for patients with substantial numbers of lymphocytes that harbor the CD4-zeta gene. Every 3 months, participants will have blood tests and specialized tests of CD4 counts, HIV-1 viral load and numbers of circulating cells containing the CD4-zeta gene every 3 months> the frequency of follow-up visits may be reduced as time goes by. - IL-2 continuation - Participants will continue to receive periodic treatment with IL-2 to see how long the genetically modified cells persist in the bloodstream and to evaluate the long-term response to IL-2. - Home treatment with interleukin-2 - Participants may receive future IL-2 treatment cycles at home. Home treatment involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle.
NCT00001521 ↗ Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia Active, not recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1995-06-08 This study was developed to determine if a combination of four drugs (flutamide, testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in children with congenital adrenal hyperplasia. The study will take 60 children, boys and girls and divide them into 2 groups based on the medications given. Group one will receive the new four- drug combination. Group two will receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and fludrocortisone). The boys in group one will take the medication until the age of 14 at which time they will stop taking the four drug combination and begin receiving the standard treatment for congenital adrenal hyperplasia. Girls in group one will take the four drug combination until the age of 13, at which time they will stop and begin receiving the standard treatment for congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until six months after their first menstrual period. All of the children will be followed until they reach their final adult height. The effectiveness of the treatment will be determined by measuring the patient's adult height, body mass index, and bone density. ...
NCT00002471 ↗ Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma Completed Memorial Sloan Kettering Cancer Center Phase 2 1990-02-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkin's lymphoma.
NCT00002494 ↗ Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia Completed National Cancer Institute (NCI) Phase 2 1992-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
NCT00002494 ↗ Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia Completed Alliance for Clinical Trials in Oncology Phase 2 1992-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
NCT00002700 ↗ Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia Completed Acute Leukemia French Association Phase 3 1995-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hydrocortisone; Urea

Condition Name

Condition Name for Hydrocortisone; Urea
Intervention Trials
Septic Shock 35
Leukemia 31
Adrenal Insufficiency 24
Acute Lymphoblastic Leukemia 23
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Condition MeSH

Condition MeSH for Hydrocortisone; Urea
Intervention Trials
Leukemia 90
Leukemia, Lymphoid 70
Precursor Cell Lymphoblastic Leukemia-Lymphoma 69
Shock, Septic 43
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Clinical Trial Locations for Hydrocortisone; Urea

Trials by Country

Trials by Country for Hydrocortisone; Urea
Location Trials
Canada 148
Australia 60
United Kingdom 44
France 44
Germany 38
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Trials by US State

Trials by US State for Hydrocortisone; Urea
Location Trials
California 74
Texas 66
Tennessee 54
New York 53
Massachusetts 48
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Clinical Trial Progress for Hydrocortisone; Urea

Clinical Trial Phase

Clinical Trial Phase for Hydrocortisone; Urea
Clinical Trial Phase Trials
Phase 4 75
Phase 3 95
Phase 2/Phase 3 14
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Clinical Trial Status

Clinical Trial Status for Hydrocortisone; Urea
Clinical Trial Phase Trials
Completed 233
Recruiting 58
Terminated 37
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Clinical Trial Sponsors for Hydrocortisone; Urea

Sponsor Name

Sponsor Name for Hydrocortisone; Urea
Sponsor Trials
National Cancer Institute (NCI) 58
St. Jude Children's Research Hospital 20
Children's Oncology Group 18
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Sponsor Type

Sponsor Type for Hydrocortisone; Urea
Sponsor Trials
Other 622
Industry 117
NIH 92
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Hydrocortisone and Urea: Clinical Trials, Market Analysis, and Projections

Introduction to Hydrocortisone and Urea

Hydrocortisone, a synthetic form of the hormone cortisol, is widely used for its anti-inflammatory and immunosuppressive properties. When combined with urea, it enhances the therapeutic effects, particularly in dermatological conditions. Here, we delve into the clinical trials, market analysis, and future projections for hydrocortisone and urea.

Clinical Trials and Efficacy

Percutaneous Penetration

Studies have shown that the addition of urea to hydrocortisone creams significantly enhances the percutaneous penetration of hydrocortisone. A crossover experiment involving five adult male volunteers demonstrated that the urinary recovery of ({}^{14})C, an index of penetration, increased approximately twofold with the addition of 10% urea to the cream[1].

Urea and Hydrocortisone Combination Therapy

A comprehensive study involving 1905 patients with atopic constitutional neurodermatitis highlighted the efficacy of combining urea and hydrocortisone. The study found that 84% of the patients showed very good to good results, with local therapy using other corticosteroids necessary in only 16% of the cases. Urea played a crucial role in regulating corneal layer lipids, reducing itching, and diminishing the susceptibility of the skin to infections[4].

Market Analysis

Global Hydrocortisone Market

The global hydrocortisone market is experiencing robust growth driven by several factors. As of 2023, the market size was valued at $1.43 billion and is projected to grow to $1.52 billion in 2024, with a compound annual growth rate (CAGR) of 6.4%. By 2028, the market is expected to reach $1.96 billion, driven by technological advancements, increased demand for over-the-counter (OTC) products, and expanded distribution channels[2].

Hydrocortisone Cream Market

The hydrocortisone cream segment is a significant part of the overall market. In 2024, the global hydrocortisone cream market size is estimated to be $1,352.2 million, with a projected CAGR of 6.50% from 2024 to 2031. This growth is attributed to the increasing incidence of cutaneous conditions and the sophisticated healthcare infrastructure in regions like North America and Europe[5].

Regional Market Dynamics

  • North America: Currently dominates the hydrocortisone cream market with a market size of $540.88 million in 2024, expected to grow at a CAGR of 4.7% from 2024 to 2031[5].
  • Europe: Holds around 30% of the global revenue with a market size of $405.66 million in 2024, expected to grow at a CAGR of 5.0% from 2024 to 2031[5].
  • Asia-Pacific: Expected to make significant gains with the highest CAGR of 8.5% from 2024 to 2031, driven by increasing healthcare expenditure and growing consumer awareness of skin health[5].

Market Trends and Drivers

Rising Prevalence of Skin Disorders

The increasing prevalence of skin disorders such as dermatitis, eczema, and other cutaneous conditions is a major driver of the hydrocortisone market. This trend is expected to continue, fueling the demand for hydrocortisone and urea-based products[2][5].

Technological Advancements

Advancements in pharmaceutical technology are enhancing the formulation and delivery of hydrocortisone, making it more effective and user-friendly. This includes the development of combination therapies and personalized treatments[2][3].

Natural Ingredient Focus

There is a growing trend towards natural ingredients in skincare products. Urea, being a natural moisturizer, fits well into this trend, making hydrocortisone-urea combinations more appealing to consumers seeking natural and effective treatments[2].

Expanded Distribution Channels

The expansion of distribution channels, including online pharmacies and retail pharmacies, is making hydrocortisone products more accessible to a wider audience. This increased accessibility is a significant factor in the market's growth[2][5].

Future Projections

Market Growth

By 2028, the global hydrocortisone market is expected to reach $1.96 billion, with a CAGR of 6.6% from 2024 to 2028. The hydrocortisone cream market is projected to grow to $2,101.3 million by 2031, with a CAGR of 6.50% from 2024 to 2031[2][5].

Emerging Markets

Emerging economies such as China and India are expected to contribute significantly to the growth of the hydrocortisone market. Increased healthcare expenditure, improved access to healthcare services, and growing consumer awareness of skin health are key drivers in these regions[5].

Key Takeaways

  • Enhanced Penetration: The addition of urea to hydrocortisone creams significantly enhances percutaneous penetration.
  • Efficacy: Combination therapy of urea and hydrocortisone shows high efficacy in treating dermatological conditions.
  • Market Growth: The global hydrocortisone market is expected to grow from $1.43 billion in 2023 to $1.96 billion by 2028.
  • Regional Dynamics: North America and Europe dominate the market, but Asia-Pacific is expected to show the highest growth rate.
  • Trends: Natural ingredient focus, technological advancements, and expanded distribution channels are key market trends.

FAQs

What is the primary benefit of combining urea with hydrocortisone in dermatological treatments?

The primary benefit is the enhanced percutaneous penetration of hydrocortisone, which increases the efficacy of the treatment.

What are the key drivers of the global hydrocortisone market?

The key drivers include the rising prevalence of skin disorders, technological advancements, increased demand for OTC products, and expanded distribution channels.

Which region is expected to show the highest growth rate in the hydrocortisone cream market?

The Asia-Pacific region is expected to show the highest growth rate with a CAGR of 8.5% from 2024 to 2031.

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

The global hydrocortisone cream market is projected to reach $2,101.3 million by 2031.

How does urea contribute to the treatment of atopic constitutional neurodermatitis?

Urea regulates corneal layer lipids, reduces itching, and diminishes the susceptibility of the skin to infections, making it an effective component in the treatment of atopic constitutional neurodermatitis.

Sources

  1. Feldmann RJ, Maibach HI. "Percutaneous Penetration of Hydrocortisone With Urea." Arch Dermatol. 1974;109(1):58–59. doi:10.1001/archderm.1974.01630010038008
  2. The Business Research Company. "Global Hydrocortisone Market Report 2024."
  3. Transparency Market Research. "Hydrocortisone Market to Reach a Value of US$2 Bn by 2028."
  4. PubMed. "Results and consequences of long-term urea therapy for atopic constitutional neurodermatitis."
  5. Cognitive Market Research. "Hydrocortisone Cream Market Report 2024 (Global Edition)."

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