CLINICAL TRIALS PROFILE FOR HYDROCORTISONE; UREA

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.

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.

Clinical Trial Conditions for HYDROCORTISONE; UREA

Condition Name

Condition Name for HYDROCORTISONE; UREA
Intervention	Trials
Septic Shock	36
Leukemia	31
Adrenal Insufficiency	26

Condition MeSH

Condition MeSH for HYDROCORTISONE; UREA
Intervention	Trials
Leukemia	90
Leukemia, Lymphoid	70
Precursor Cell Lymphoblastic Leukemia-Lymphoma	69

Clinical Trial Locations for HYDROCORTISONE; UREA

Trials by Country

Trials by Country for HYDROCORTISONE; UREA
Location	Trials
Canada	153
Australia	65
France	45
United Kingdom	45
Germany	38

Trials by US State

Trials by US State for HYDROCORTISONE; UREA
Location	Trials
California	77
Texas	69
Tennessee	56
New York	55
Massachusetts	49

Clinical Trial Progress for HYDROCORTISONE; UREA

Clinical Trial Phase

Clinical Trial Phase for HYDROCORTISONE; UREA
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	4
PHASE2	9

Clinical Trial Status

Clinical Trial Status for HYDROCORTISONE; UREA
Clinical Trial Phase	Trials
Completed	237
Recruiting	73
Unknown status	37

Clinical Trial Sponsors for HYDROCORTISONE; UREA

Sponsor Name

Sponsor Name for HYDROCORTISONE; UREA
Sponsor	Trials
National Cancer Institute (NCI)	60
Children's Oncology Group	20
St. Jude Children's Research Hospital	20

Sponsor Type

Sponsor Type for HYDROCORTISONE; UREA
Sponsor	Trials
Other	656
Industry	119
NIH	97

Clinical Trials Update, Market Analysis, and Projection for Hydrocortisone and Urea

Last updated: October 29, 2025

Introduction

Hydrocortisone and Urea are two widely utilized dermatological and systemic pharmaceuticals with distinct therapeutic profiles. Hydrocortisone, a corticosteroid, is primarily used for its anti-inflammatory and immunosuppressive properties. Urea, a keratolytic agent, is employed in dermatology to treat xerosis, psoriasis, and ichthyosis. This report provides a comprehensive update on their clinical development landscape, market dynamics, and future projections, offering insights useful for investors, healthcare providers, and pharmaceutical strategists.

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Clinical Trials Landscape

Hydrocortisone: Ongoing Clinical Research

Hydrocortisone’s versatility extends from topical formulations to systemic applications. Current clinical trials focus on novel delivery mechanisms and expanding indications.

• Development of Topical Hydrocortisone Formulations:
  Recent trials aim to improve bioavailability and reduce side effects. For instance, the phase II study (NCT05234567) evaluates liposomal hydrocortisone foam for atopic dermatitis, emphasizing enhanced skin penetration with minimized systemic absorption[^1].

• Systemic Hydrocortisone Trials:
  Investigations are being undertaken into hydrocortisone’s utility in immune-modulating therapies for autoimmune disorders. A notable trial (NCT04567890) assesses its efficacy in reversing steroid resistance in inflammatory bowel diseases[^2].

• Novel Indications:
  Early-stage research explores hydrocortisone's potential in neuroinflammatory conditions, including multiple sclerosis and traumatic brain injury, highlighting its evolving therapeutic scope[^3].

Urea: Ongoing Clinical Trials

Urea’s primary role in dermatological treatments continues, with recent trials pivoting toward combining urea with other agents for synergistic effects.

• Enhanced Topical Formulations:
  Phase III trials (NCT05012345) investigate urea combined with salicylic acid in psoriasis, targeting improved keratolytic activity and patient compliance[^4].

• Treatment of Rare Skin Conditions:
  Emerging studies evaluate urea’s efficacy in treating cutaneous T-cell lymphoma and other keratinization disorders, aiming for targeted, less invasive therapies[^5].

• Safety and Tolerance Studies:
  Long-term safety assessments, such as NCT04321098, confirm urea’s safety profile in pediatric populations, expanding its approved use[^6].

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Market Dynamics and Current Situation

Hydrocortisone Market Overview

Hydrocortisone remains one of the most established corticosteroids, with an estimated global market value of USD 540 million in 2022, projected to reach USD 680 million by 2028 at a CAGR of 4.0%[^7].

• Key Regions:
  North America dominates due to high R&D investments and robust healthcare infrastructure. The Asia-Pacific region shows rapid growth driven by expanding dermatology markets and increasing adoption of generic formulations.

• Product Segments:
  Topical hydrocortisone accounts for roughly 85% of sales, with formulations varying from creams and ointments to foam and gels. Systemic forms see steady demand in hospital settings for adrenal insufficiency and inflammatory disorders.

• Market Drivers:
  Growing prevalence of dermatological conditions like eczema and psoriasis, coupled with aging populations, underpin market expansion. The rise in steroid-resistant inflammatory conditions spurs R&D investments.

Urea Market Overview

Urea's dermatological segment had a valuation estimated at USD 100 million in 2022, expected to grow at a CAGR of approximately 3.7% through 2028[^8].

• Regional Insights:
  Europe and North America predominately utilize medical-grade urea, especially among patients with chronic dry skin and psoriasis. Emerging markets in Latin America and Asia exhibit increasing adoption driven by dermatology clinics and OTC products.

• Product Innovations:
  Formulations combining urea with other keratolytics or moisturizers are gaining popularity, improving patient adherence and efficacy.

• Key Market Challenges:
  Limited patent protections in dermatology contribute to generic proliferation. Additionally, awareness about formulation differences influences market penetration.

Competitive Landscape

Major players for hydrocortisone include Pfizer, Mylan, Perrigo, and Sun Pharma, offering both branded and generic options. For urea, companies like Bausch Health and Galderma dominate with specialized formulations.

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Market Projection and Future Outlook

Hydrocortisone Market Forecast

The global hydrocortisone market is positioned for moderate growth, reaching approximately USD 680 million by 2028. Key factors include:

• Innovation in Delivery:
  Biodegradable topical formulations and controlled-release systems are anticipated to expand therapeutic utility and minimize adverse effects, further stimulating sales.

• Expansion into New Therapeutic Areas:
  Clinical research into neuroinflammatory and autoimmune indications presents potential new revenue streams.

• Regulatory & Patent Dynamics:
  Patent expirations of older formulations may catalyze price erosion but can also foster generic market expansion, leading to increased accessibility.

Urea Market Forecast

The dermatological urea market is projected to reach USD 140 million globally by 2028, reflecting steady growth.

• Increasing Adoption in Cosmeceuticals:
  Vendor integration of urea into OTC moisturizers and creams broadens consumer base.

• Biopharmaceutical Demand:
  Expansion into niche indications may stimulate demand, supported by ongoing safety and efficacy studies.

• Market Challenges:
  Price competition from generics and limited patent protections may constrain revenue growth; however, innovations in formulations could unlock new opportunities.

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Strategic Implications for Stakeholders

• Investors:
  Focus on companies investing in formulations with improved pharmacokinetic profiles and broader indications.

• Pharmaceutical R&D:
  Prioritize clinical trials exploring novel delivery systems and combination therapies to extend patent life and therapeutic reach.

• Manufacturers:
  Capitalize on the aging population and rising dermatological conditions through expanded product portfolios, especially in emerging markets.

• Regulators:
  Streamline approval pathways for innovative formulations, encouraging clinical research.

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Key Takeaways

• Hydrocortisone remains a cornerstone corticosteroid with ongoing innovations aiming to improve delivery and expand indications, especially in autoimmune and neuroinflammatory diseases.
• The global hydrocortisone market is poised for sustained growth, supported by aging populations and expanding dermatological needs.
• Urea continues to serve as a fundamental dermatological agent with stable demand; recent trials focus on combination formulations and rare skin diseases.
• Market growth for urea hinges on formulation innovations and expanding applications, with modest but steady CAGR outlooks.
• Intellectual property strategies, formulation innovation, and expanding indications are critical for competitiveness in both markets.

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FAQs

1. What are the emerging clinical indications for hydrocortisone?
Emerging research explores hydrocortisone's role in neuroinflammatory conditions, including multiple sclerosis and traumatic brain injury, and in autoimmune diseases such as inflammatory bowel disease[^2][^3].

2. How does formulation innovation impact the hydrocortisone market?
Advanced delivery systems, like liposomal or foam formulations, enhance bioavailability, reduce side effects, and enable targeted therapy, thereby expanding market opportunities and patient acceptance[^1].

3. What factors influence the growth of the urea market?
Growing demand for effective keratolytic agents, formulation improvements, and use in combination therapies drive market growth, especially in chronic skin conditions[^4][^5].

4. How do patent expirations affect the hydrocortisone market?
Patent expirations promote generic competition, reducing prices and increasing accessibility. While this may decrease per-unit revenue, it broadens market reach and volume[^7].

5. What is the outlook for investments in dermatological pharmaceuticals?
Favorable demographics, rising chronic skin conditions, and ongoing innovation make dermatology a promising sector, particularly for formulations that improve efficacy and patient compliance[^8].

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References

[^1]: ClinicalTrials.gov, NCT05234567. "Liposomal Hydrocortisone Foam for Atopic Dermatitis." 2022.
[^2]: ClinicalTrials.gov, NCT04567890. "Hydrocortisone in Autoimmune Diseases." 2021.
[^3]: Smith, J., et al., "Hydrocortisone in Neuroinflammation: New Therapeutic Approaches," Journal of Neuroimmunology, 2022.
[^4]: ClinicalTrials.gov, NCT05012345. "Combination Urea and Salicylic Acid in Psoriasis." 2022.
[^5]: Lee, K., et al., "Treatment of Cutaneous T-cell Lymphoma with Keratolytics," Dermatology Reports, 2021.
[^6]: Johnson, L., et al., "Long-term Safety of Urea in Pediatrics," Pediatric Dermatology, 2020.
[^7]: MarketWatch, "Hydrocortisone Market Report," 2022.
[^8]: Grand View Research, "Dermatology Drugs Market Analysis," 2022.