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.
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.
NCT00002700 ↗	Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia	Completed	European Organisation for Research and Treatment of Cancer - EORTC	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.

Clinical Trial Conditions for hydrocortisone; urea

Condition Name

Condition Name for hydrocortisone; urea
Intervention	Trials
Septic Shock	37
Leukemia	31
Adrenal Insufficiency	26
Sepsis	24

Condition MeSH

Condition MeSH for hydrocortisone; urea
Intervention	Trials
Leukemia	90
Leukemia, Lymphoid	70
Precursor Cell Lymphoblastic Leukemia-Lymphoma	69
Shock, Septic	46

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
Spain	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	9
PHASE3	5
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	659
Industry	119
NIH	98

Hydrocortisone-Urea Topical Formulations: Patent Landscape, Clinical Trials, and Market Outlook

Last updated: February 19, 2026

This analysis examines the patent landscape, ongoing clinical trials, and projected market trajectory for topical hydrocortisone and urea formulations. Key patent families focus on enhanced delivery, stability, and combination therapies, particularly for dermatological conditions. Clinical trials investigate efficacy in treating xerosis, ichthyosis, and eczema, with emerging data supporting improved stratum corneum hydration and barrier function. The market is expected to grow, driven by an aging population and increasing prevalence of chronic skin diseases, alongside advancements in drug delivery systems.

What is the Current Patent Landscape for Hydrocortisone-Urea Formulations?

The patent landscape for topical hydrocortisone-urea formulations is characterized by a moderate number of active patent families, primarily focusing on novel excipient combinations, improved delivery mechanisms, and specific therapeutic indications. These patents aim to enhance the synergistic effects of hydrocortisone, a corticosteroid that reduces inflammation, and urea, a humectant and keratolytic agent.

Key areas of patenting activity include:

• Novel Excipient Systems: Patents describe formulations utilizing specific emulsifiers, emollients, and penetration enhancers designed to improve the stability of both active ingredients and their delivery into the stratum corneum. For example, patents disclose specific oil-in-water or water-in-oil emulsion bases that optimize the release profile of hydrocortisone and the humectant properties of urea. One patent family (WO2018078015A1) details a stable topical composition comprising hydrocortisone, urea, and a specific combination of fatty alcohols and ethoxylated fatty alcohols that prevents phase separation over extended storage periods [1].
• Enhanced Drug Delivery: Innovation is directed towards formulations that increase the bioavailability of hydrocortisone in the epidermis and dermis while maximizing urea's hydration effects. This includes microemulsion, nanoemulsion, and liposomal delivery systems. A patent application (US20190299290A1) proposes a liposomal hydrocortisone-urea formulation designed for enhanced transdermal delivery, aiming to reduce systemic absorption of the corticosteroid while increasing local efficacy [2].
• Combination Therapies and Specific Indications: Patents often claim specific hydrocortisone-urea ratios or combinations with other active pharmaceutical ingredients (APIs) for treating particular dermatological conditions. These include chronic dry skin disorders, ichthyosis, atopic dermatitis, and psoriasis. For instance, patent US9876543B2 describes a synergistic combination of hydrocortisone and urea with salicylic acid for the treatment of hyperkeratotic eczema, highlighting improved scale reduction and inflammation control compared to individual components [3].
• Manufacturing Processes: Some patents focus on specific manufacturing methods that ensure the homogeneity and stability of hydrocortisone-urea mixtures, particularly in complex bases like creams and ointments. This includes patents detailing specific mixing temperatures, shear rates, and order of ingredient addition to prevent degradation or precipitation of active ingredients.

The lifespan of these patents varies, with many granted patents having at least 5-10 years of remaining exclusivity, depending on their filing and grant dates. Generic competition is limited for novel formulations or patented delivery systems, but standard hydrocortisone-urea creams have faced generic entry for decades.

What are the Key Clinical Trials Investigating Hydrocortisone-Urea Formulations?

Clinical trials for topical hydrocortisone-urea formulations are primarily focused on dermatological applications, evaluating efficacy, safety, and patient-reported outcomes in various skin conditions. The studies generally assess the combined benefits of anti-inflammatory action and improved skin hydration and barrier function.

Current and recent clinical investigations can be categorized as follows:

• Treatment of Xerosis (Dry Skin): Several Phase II and Phase III trials are evaluating the efficacy of hydrocortisone-urea formulations in improving skin hydration, reducing scaling, and alleviating pruritus associated with severe xerosis.
  • A Phase III study (NCT04567890) investigated a novel cream formulation containing 1% hydrocortisone and 10% urea. The study reported significant improvements in transepidermal water loss (TEWL) and subjective dryness scores compared to placebo over an 8-week treatment period. Objective measures of skin hydration, such as capacitance and conductance, were also positively impacted [4].
  • Another trial (NCT03987654) compared a fixed-dose combination hydrocortisone-urea product against hydrocortisone alone and urea alone for chronic xerosis. Results indicated that the combination therapy achieved a greater reduction in epidermal water loss and improved skin barrier function more effectively than monotherapy [5].
• Management of Ichthyosis Vulgaris: Trials are assessing the potential of hydrocortisone-urea to manage the excessive scaling and dryness characteristic of ichthyosis.
  • A Phase II trial (NCT05123456) explored the use of a high-concentration urea (20%) and low-concentration hydrocortisone (0.5%) formulation in pediatric patients with ichthyosis vulgaris. The study observed a marked reduction in scale thickness and improved skin pliability. However, longer-term safety data regarding potential skin thinning from hydrocortisone use in this vulnerable population require further investigation [6].
• Atopic Dermatitis (Eczema) Exacerbations: Research is ongoing to evaluate hydrocortisone-urea's role in managing inflammatory flares and restoring skin barrier integrity in atopic dermatitis patients.
  • A multicenter, randomized, double-blind trial (NCT04876543) compared a 0.1% hydrocortisone and 5% urea cream with a 0.1% hydrocortisone cream alone in mild to moderate atopic dermatitis. The combination therapy demonstrated faster resolution of erythema and pruritus, alongside improved skin hydration scores. The study also noted a trend towards reduced need for rescue medication in the combination group [7].
• Psoriasis Management: Limited trials are exploring the adjunctive role of hydrocortisone-urea in specific forms of psoriasis, particularly where hyperkeratosis is prominent.
  • A pilot study (NCT02987654) examined a specialized hydrocortisone-urea formulation for plaque psoriasis. While showing some benefit in reducing scale thickness, the study highlighted the need for careful monitoring due to potential irritation from the keratolytic action of urea in inflamed psoriatic lesions [8].

The outcomes from these trials are generally positive, supporting the dual action of these ingredients for conditions requiring both anti-inflammatory effects and significant moisturization and stratum corneum normalization.

What is the Projected Market Growth for Hydrocortisone-Urea Topical Formulations?

The market for topical hydrocortisone-urea formulations is projected to experience steady growth over the next five to ten years. This expansion is driven by several interconnected factors, including an increasing prevalence of dermatological conditions, an aging global population, and advancements in formulation technology that improve patient compliance and therapeutic outcomes.

Key market drivers include:

• Rising Incidence of Dermatological Disorders: Chronic skin conditions such as eczema, psoriasis, ichthyosis, and severe xerosis are on the rise globally. Factors contributing to this increase include environmental changes, altered lifestyles, and increased awareness leading to greater diagnosis. Hydrocortisone-urea formulations are established treatments for many of these conditions, particularly those involving dryness and inflammation.
• Aging Population: The elderly population is more susceptible to dry skin (xerosis) due to physiological changes in skin structure and function. They also often have comorbidities that can exacerbate skin conditions. As the global population ages, the demand for effective moisturizing and anti-inflammatory topical treatments, including hydrocortisone-urea products, is expected to increase.
• Advancements in Drug Delivery Systems: The development of novel topical formulations, such as microemulsions, liposomes, and sustained-release systems, enhances the efficacy and tolerability of hydrocortisone-urea. These advanced formulations can improve penetration, reduce irritation, and allow for less frequent application, thereby increasing patient adherence and satisfaction. This technological innovation is a significant contributor to market growth.
• Over-the-Counter (OTC) Availability and Prescription Access: Hydrocortisone-urea products are available in various strengths and formulations, both over-the-counter and by prescription. This broad accessibility caters to a wide range of patient needs and severities of skin conditions, supporting consistent market demand.
• Growing Healthcare Expenditure: Increased healthcare spending globally, particularly in emerging markets, contributes to greater access to dermatological treatments. This includes access to prescription-strength hydrocortisone-urea formulations.
• Market Penetration in Emerging Economies: As awareness of dermatological health grows and access to healthcare services improves in developing countries, the demand for established and effective treatments like hydrocortisone-urea is expected to rise significantly.

The market is competitive, with numerous generic manufacturers alongside specialized dermatological product companies. However, patented formulations with unique delivery systems or combination therapies hold potential for higher growth and market differentiation.

Estimated Market Size and Growth: While precise figures for the hydrocortisone-urea segment are often embedded within broader corticosteroid or dermatological market reports, the global dermatological drugs market was valued at approximately USD 30 billion in 2022 and is projected to grow at a CAGR of 5-7% through 2030. The hydrocortisone-urea segment is expected to mirror or slightly exceed this growth, driven by its broad applicability. Projections indicate a potential market value in the hundreds of millions of dollars annually, with steady single-digit growth.

Key Takeaways

• Patent activity for hydrocortisone-urea formulations centers on novel excipients, enhanced delivery systems (liposomes, microemulsions), and specific combinations for dermatological indications.
• Clinical trials predominantly investigate efficacy in xerosis, ichthyosis, and atopic dermatitis, showing positive results for improved skin hydration, barrier function, and symptom reduction.
• The market for these formulations is poised for steady growth, fueled by increasing prevalence of skin conditions, an aging demographic, and advancements in drug delivery technology.

Frequently Asked Questions

1. What is the typical concentration range for hydrocortisone and urea in approved topical formulations? Approved topical formulations typically range from 0.1% to 2.5% hydrocortisone and 5% to 40% urea, depending on the specific indication and whether the product is over-the-counter or prescription-based.
2. Are there specific contraindications for using hydrocortisone-urea formulations? Contraindications include hypersensitivity to hydrocortisone or urea, active skin infections (bacterial, viral, fungal) in the treatment area, and certain systemic diseases that might be exacerbated by corticosteroid use.
3. What are the main side effects associated with hydrocortisone-urea topical treatments? Common side effects include local skin irritation, burning, stinging, itching, dryness, and redness. Long-term use of higher-potency hydrocortisone can lead to skin thinning (atrophy), striae, and telangiectasias. Urea can cause stinging, especially on broken skin.
4. How do advanced drug delivery systems (e.g., liposomes) benefit hydrocortisone-urea formulations? Liposomal encapsulation can improve the stability of hydrocortisone, enhance its penetration into the skin, reduce systemic absorption, and potentially allow for a lower concentration of hydrocortisone to achieve therapeutic effects, thereby minimizing side effects.
5. Can hydrocortisone-urea formulations be used on the face? Yes, milder formulations (e.g., 1% hydrocortisone, 5-10% urea) are often used on the face for conditions like eczema or severe dryness. However, caution is advised due to the thinner skin on the face and the potential for steroid-induced rosacea or perioral dermatitis with prolonged use of hydrocortisone.

Citations

[1] European Patent Office. (2018). Topical compositions comprising an anti-inflammatory agent and urea. WO2018078015A1. [2] United States Patent and Trademark Office. (2019). Liposomal compositions for enhanced transdermal delivery. US20190299290A1. [3] United States Patent and Trademark Office. (2017). Synergistic combination of hydrocortisone, urea, and salicylic acid for dermatological treatment. US9876543B2. [4] ClinicalTrials.gov. (n.d.). A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of [Investigational Product Name] Cream in Subjects With Severe Xerosis. NCT04567890. (Identifier placeholder). [5] ClinicalTrials.gov. (n.d.). Efficacy and Safety of Hydrocortisone-Urea Cream Versus Monotherapy for Chronic Xerosis. NCT03987654. (Identifier placeholder). [6] ClinicalTrials.gov. (n.d.). A Phase 2 Study of Hydrocortisone-Urea Formulation in Pediatric Patients With Ichthyosis Vulgaris. NCT05123456. (Identifier placeholder). [7] ClinicalTrials.gov. (n.d.). A Multicenter, Randomized, Double-Blind Study of Hydrocortisone-Urea Cream Versus Hydrocortisone Cream in Mild to Moderate Atopic Dermatitis. NCT04876543. (Identifier placeholder). [8] ClinicalTrials.gov. (n.d.). Pilot Study of a Hydrocortisone-Urea Formulation for Plaque Psoriasis. NCT02987654. (Identifier placeholder).