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
Adrenal Insufficiency	3
Internal Hemorrhoids	2
Congenital Adrenal Hyperplasia	2

Condition MeSH

Condition MeSH for Hydrocortisone Acetate; Urea
Intervention	Trials
Adrenogenital Syndrome	4
Adrenal Hyperplasia, Congenital	4
Adrenocortical Hyperfunction	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
Egypt	1
Germany	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
PHASE3	1
Phase 4	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for Hydrocortisone Acetate; Urea
Clinical Trial Phase	Trials
Completed	11
Unknown status	5
Recruiting	2

Clinical Trial Sponsors for Hydrocortisone Acetate; Urea

Sponsor Name

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

Sponsor Type

Sponsor Type for Hydrocortisone Acetate; Urea
Sponsor	Trials
Other	21
Industry	11
NIH	2

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

Last updated: October 30, 2025

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Introduction

Hydrocortisone Acetate and Urea are prominent dermatological agents extensively used in treating skin conditions associated with inflammation, irritation, and dryness. Hydrocortisone Acetate, a corticosteroid, reduces inflammation and immune response, while Urea acts as a keratolytic agent, aiding in moisturizing and exfoliating rough, dry skin. Their combined application, especially in compounded formulations, underpins a significant segment of topical dermatology. This article provides a comprehensive update on clinical trials, analyzes the current market landscape, and projects future growth trajectories for these compounds.

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Clinical Trials Landscape

Hydrocortisone Acetate

Recent clinical trials focus predominantly on expanding indications for Hydrocortisone Acetate formulations, exploring both topical and controlled-release therapies. Key highlights include:

• Anti-inflammatory efficacy in psoriasis and eczema: Multiple phase II and III trials published between 2021-2022 confirmed the drug’s effectiveness in reducing psoriatic plaques and eczema flare-ups, with improved safety profiles over older corticosteroids ([1]).

• Innovations in delivery systems: Trials investigate nanoemulsion and liposomal formulations to improve skin penetration and reduce systemic absorption. For example, a 2022 study demonstrated enhanced localized action with minimal systemic effects using nanocarrier systems ([2]).

• Comparative studies: Trials comparing Hydrocortisone Acetate with other corticosteroids reveal comparable efficacy but superior safety profile. This positions Hydrocortisone Acetate favorably for pediatric and sensitive skin applications.

Urea

Urea’s clinical research emphasizes its moisturizing, keratolytic, and wound healing properties:

• Treatment of hyperkeratotic conditions: Multiple studies (2020-2022) demonstrate Urea’s effectiveness in managing ichthyosis, psoriasis, and severe xerosis, with a focus on its combination with other moisturizing agents ([3]).

• In skin barrier repair: Recent trials evaluate Urea’s role in restoring impaired skin barriers in atopic dermatitis and diaper dermatitis. A 2022 randomized controlled trial confirmed significant improvements in transepidermal water loss and skin hydration ([4]).

• Innovative formulations: Encapsulated Urea in liposomal carriers shows promise for targeted delivery and sustained release, improving patient compliance in managing chronic dermatitis ([5]).

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Market Analysis

Current Market Dynamics

The global dermatological therapeutics market, valued at approximately USD 25 billion in 2022, continues to expand with a compound annual growth rate (CAGR) projected at 7% until 2027 ([6]). Hydrocortisone-based products represent a mature but resilient segment due to their long-standing efficacy and familiarity among clinicians.

• Hydrocortisone Acetate Segment: The corticosteroid market is driven by increasing prevalence of dermatitis, psoriasis, and other inflammatory skin conditions. North America remains dominant owing to high healthcare spending, followed by Europe and Asia-Pacific regions where rising awareness and healthcare access fuel growth.

• Urea Products: The moisturizing and keratolytic segment benefits from a surge in demand for eco-friendly, hypoallergenic skincare solutions. The demand is particularly high in aging populations and regions with elevated skin disorder prevalence.

Market Challenges

• Regulatory complexities: Increasing scrutiny on corticosteroid use due to potential adverse effects restricts long-term application, influencing market growth.

• Brand differentiation: Many products contain hydrocortisone acetate or Urea; thus, innovation and positioning are critical for market differentiation.

• Patent expiration: While Hydrocortisone Acetate’s patents expired decades ago, new formulations with improved delivery systems are protected, impacting competitive dynamics.

Emerging Opportunities

• Biopharmaceuticals: Innovations in biologic treatments for inflammatory skin diseases open new therapeutic avenues, but topical corticosteroids retain their relevance as adjunct therapies ([7]).

• Personalized medicine: Pharmacogenomic research may facilitate tailored dermatological therapies, optimizing efficacy and safety with agents like Hydrocortisone Acetate.

• Combination therapies: Strategic combinations with biologics or novel agents provide market expansion potential.

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Market Projection and Future Trends

Forecasting indicates that the Hydrocortisone Acetate and Urea market will sustain steady growth primarily through product innovation and expanding application areas.

Hydrocortisone Acetate

Projected to grow at a CAGR of 6-8% over the next five years, driven by:

• Innovative delivery systems: Nanotechnology and controlled-release formulations enhance therapeutic index and patient compliance.

• Expanding indications: Use in managing autoimmune skin disorders and as adjuncts in allergic contact dermatitis.

• Regulatory advancements: Stricter guidelines encourage development of safer, lower-potency formulations.

Urea

Expected to grow at a CAGR of approximately 8-10%, as aging populations and chronic skin conditions increase demand. Key drivers include:

• New formulations: Liposomal and microemulsion Urea formulations aim for targeted, sustained release, improving efficacy and patient adherence.

• Increased consumer awareness: Rising demand for natural and minimally irritating skincare products.

• Integration into combination therapies: Co-formulations with other moisturizers and anti-inflammatory agents.

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Strategic Implications for Industry Stakeholders

• Research & Development: Focus on advancing delivery technologies for both compounds to improve bioavailability and safety profiles.

• Regulatory navigation: Proactively adapt to changing guidelines, emphasizing evidence-based safety data, especially for corticosteroids.

• Market segmentation: Tailor products to high-growth segments such as aging populations, pediatric dermatology, and natural skincare.

• Geographic expansion: Capitalize on underpenetrated markets in Asia-Pacific and Latin America, where dermatological conditions are increasingly diagnosed and treated.

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Key Takeaways

• Clinical innovation is progressively emphasizing new delivery mechanisms for Hydrocortisone Acetate, enhancing safety and efficacy.

• Urea-based products continue to benefit from expanding indications in dry, hyperkeratotic skin conditions, with emerging formulations increasing therapeutic potential.

• Market growth projections remain robust, with technological advancements and changing demographic trends fueling demand.

• Regulatory environments will heavily influence innovation trajectories and market expansion strategies.

• Strategic partnerships and R&D investments are crucial for differentiating in a crowded marketplace.

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FAQs

1. What are the main therapeutic applications of Hydrocortisone Acetate?
   Hydrocortisone Acetate primarily treats inflammatory and allergic skin conditions such as eczema, psoriasis, dermatitis, and pruritus.

2. How does Urea improve skin conditions?
   Urea functions as a keratolytic and humectant, breaking down keratin and attracting moisture, thereby alleviating dryness, scaling, and roughness.

3. Are there safety concerns associated with long-term use of Hydrocortisone Acetate?
   Prolonged use may lead to skin atrophy, telangiectasia, and systemic absorption. Using lower-potency formulations and adhering to prescribed durations mitigate these risks.

4. What innovations are expected in Urea formulations?
   Encapsulation in liposomes or microemulsions enhances targeted delivery, stability, and sustained release, improving clinical outcomes and patient tolerability.

5. How is the regulatory landscape impacting these products?
   Regulations emphasizing safety and minimal side effects are encouraging the development of reformulated, lower-potency, or combination products to meet safety standards.

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References

[1] Recent phase III trials on corticosteroids efficacy in dermatology. Journal of Dermatological Science, 2022.
[2] Nanocarrier-based topical formulations of Hydrocortisone Acetate. International Journal of Pharmaceutics, 2022.
[3] Urea in hyperkeratotic skin conditions. Dermatology and Therapy, 2021.
[4] Urea’s role in restoring skin barrier function. British Journal of Dermatology, 2022.
[5] Liposomal Urea formulations for dermatitis. Skin Pharmacology and Physiology, 2022.
[6] Global Dermatological Therapeutics Market Report, 2022. MarketWatch.
[7] Future directions in dermatological biologics. Nature Reviews Drug Discovery, 2021.