CLINICAL TRIALS PROFILE FOR ULTRAVATE

All Clinical Trials for Ultravate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00865267 ↗	The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects	Completed	Actavis Inc.	Phase 1	2003-12-01	The purpose of this study is to determine the duration of application of halobetasol propionate 0.05% ointment to be used in a definitive study of bioequivalence of to formulations of this ointment. Part A: To validate vasoconstrictor assay precision. Part B: To evaluate the dose response vasoconstriction profile of Ultravate® 0.05% ointment at different dose durations over a short period of time (0.17 - 4 hrs).
NCT00865605 ↗	Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects	Completed	Actavis Inc.	Phase 1	2003-12-01	The purpose of this study is to compare the vasoconstriction response profile and bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).
NCT00990561 ↗	Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis	Completed	University of California, San Francisco	Phase 4	2009-07-01	This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis plaques will be evaluated to test efficacy of the medication. Half the subjects will be randomized to receive treatment with once a day Ultravate® ointment and twice daily Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment phase will consist of a four-week observation period. Subjects will be re-randomized to either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this clinical study consists of the use of patient and physician satisfaction questionnaires. These questionnaires will include questions about the satisfaction with the formulation of each agent, questions about compliance with treatment, etc. Such questions could be used to demonstrate patient and physician satisfaction with each agent, with combination therapy, and to compare patient satisfaction rates among those randomized to once daily versus twice daily application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice daily in combination with Lac-Hydrin twice daily.
NCT01111123 ↗	Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis	Completed	Icahn School of Medicine at Mount Sinai	Phase 4	2009-01-01	The purpose of this study is to determine whether the combinational use of ammonium lactate lotion 12% (Lac-Hydrin) and halobetasol propionate ointment 0.05% (Ultravate) is safe and effective in the initial treatment and long-term maintenance of psoriasis. Patients will use both medications continuously for two weeks and those who obtain a good improvement based on investigator clinical assessments will be randomized to Lac-Hydrin lotion twice daily every day with placebo ointment or Ultravate ointment twice daily on weekends only for up to 24 more weeks.
NCT01166646 ↗	Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis	Completed	Therapeutics, Inc.	Phase 2	2010-07-01	The purpose of this study is to determine whether the investigational lotion is an effective treatment of moderate to severe plaque psoriasis in comparison to an approved cream.
NCT02785172 ↗	Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis	Completed	Bausch Health Americas, Inc.	Phase 2	2016-04-01	Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

Clinical Trial Conditions for Ultravate

Condition Name

Condition Name for Ultravate
Intervention	Trials
Psoriasis	3
Healthy	2
Plaque Psoriasis	2
Stable Plaque Psoriasis	1

Condition MeSH

Condition MeSH for Ultravate
Intervention	Trials
Psoriasis	6

Clinical Trial Locations for Ultravate

Trials by Country

Trials by Country for Ultravate
Location	Trials
United States	31

Trials by US State

Trials by US State for Ultravate
Location	Trials
California	7
Texas	4
Florida	3
North Carolina	3
Indiana	2

Clinical Trial Progress for Ultravate

Clinical Trial Phase

Clinical Trial Phase for Ultravate
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	3
Phase 1	3

Clinical Trial Status

Clinical Trial Status for Ultravate
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for Ultravate

Sponsor Name

Sponsor Name for Ultravate
Sponsor	Trials
Valeant Pharmaceuticals International, Inc.	3
Bausch Health Americas, Inc.	3
Actavis Inc.	2

Sponsor Type

Sponsor Type for Ultravate
Sponsor	Trials
Industry	9
Other	2

Clinical Trials Update, Market Analysis, and Projection for Ultravate (Halobetasol Propionate)

Last updated: October 30, 2025

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Introduction

Ultravate, a prescription topical corticosteroid primarily used to treat inflammatory and pruritic conditions of the skin, is marketed under the active ingredient halobetasol propionate. Its efficacy in managing psoriasis, eczema, and other dermatoses has secured its presence in dermatology. As pharmaceutical landscapes evolve, understanding recent clinical developments, market dynamics, and future growth projections for Ultravate is vital for stakeholders. This analysis synthesizes current clinical trial statuses, assesses market trends, and projects future market trajectories.

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Clinical Trials Landscape for Ultravate

Current Status of Clinical Trials

Ultravate's clinical development has historically centered on confirming its efficacy and safety in treating various dermatological conditions. According to ClinicalTrials.gov, there are no active interventional studies exclusively targeting Ultravate as of 2023, which aligns with its established market presence and regulatory approval. However, ongoing research primarily explores its application in comparative studies, combination therapies, and long-term safety assessments.

• Efficacy and Safety Studies: Past pivotal studies demonstrated Ultravate's superior anti-inflammatory effects compared to placebo and other corticosteroids, with a favorable safety profile when used as directed [1]. Notably, these trials included randomized, placebo-controlled designs with outcomes assessed via lesion clearance rates, pruritus reduction, and adverse event monitoring.

• Real-World Evidence (RWE): Emerging post-marketing studies focus on long-term safety, adherence, and off-label applications. Data from dermatology clinics indicate high patient satisfaction and reduced relapse rates when Ultravate is integrated into comprehensive treatment plans [2].

• Innovative Formulation Research: Investigations into novel delivery systems—including foam, aerosol, and gel formulations—aim to enhance patient compliance and therapeutic outcomes. These studies are at early preclinical stages or involve comparative efficacy assessments.

Pending and Future Trials

While no new large-scale clinical trials are currently registered explicitly for Ultravate, future research may focus on:

• Combination Therapy Efficacy: Combining Ulavatet with biologics or other immunomodulators for recalcitrant psoriasis.

• Extended Safety Profiling: Monitoring long-term use beyond 12 weeks, particularly in pediatric populations.

• Special Populations: Assessing safety and efficacy in pregnant women or those with comorbid conditions.

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Market Analysis of Ulvatate

Market Overview

Ulvatate, under the US brand name Ultravate, is a potent topical corticosteroid approved by the FDA. Its primary competitors include other corticosteroids such as Clobetasol Propionate, Betamethasone, and newer non-steroidal anti-inflammatory agents. The global dermatological corticosteroid market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a CAGR of 4.5% through 2030, driven by rising psoriasis and eczema prevalence [3].

Key Market Drivers

• Increasing Prevalence of Skin Conditions: Psoriasis affects over 125 million globally, with rising incidences attributable to lifestyle factors and increased awareness [4].

• Enhanced Formulations and Delivery Technologies: Innovations in topical drug delivery improve efficacy and patient adherence, fostering demand for potent corticosteroids like Ulvatate.

• Growing Geriatric Population: Older adults often exhibit chronic dermatoses requiring potent corticosteroid treatments.

• Expanding Off-label Use: Dermatologists utilize Ulvatate for various inflammatory conditions beyond its primary indications, broadening its utilization.

Market Challenges

• Steroid-Related Adverse Effects: Long-term or inappropriate use risks skin atrophy, striae, and systemic absorption, prompting regulatory and clinician caution [5].

• Regulatory Scrutiny and Thinning Patent Protection: Patent expiry and the entry of generic equivalents intensify price competition.

• Preference for Non-steroidal Alternatives: Biologics and immunomodulators are increasingly favored for refractory skin diseases, potentially limiting corticosteroid growth.

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Market Projection and Growth Outlook

Short-Term (Next 3 Years)

Market growth for Ulvatate is anticipated to remain steady, driven by incremental expansion within established dermatology practices and ongoing formulation improvements. The launch of newer topical formulations (e.g., foam, spray) may contribute to increased prescribing, especially among younger demographics seeking non-greasy options.

Medium to Long-Term (3-10 Years)

Projected continued growth hinges on:

• Innovative Formulation Adoption: Introduction of higher bioavailability formulations with improved safety profiles could expand use cases.

• Market Expansion: Penetration into emerging markets where dermatological conditions are underdiagnosed or undertreated. Rapid urbanization and rising disposable incomes facilitate this trend.

• Regulatory Approvals for Broader Use: Pending approvals for pediatric or specific demographic subgroups could unlock new markets.

• Competitive Landscape Dynamics: Competition from biosimilars or non-steroidal drugs may temper growth rates but also stimulate innovation.

Market Share and Revenue Projections

By 2030, Ulvatate's global market share could approach 5-8% within the topical corticosteroid segment, with revenues potentially exceeding USD 300 million annually, assuming steady adoption and formulation diversification, based on current market trajectories.

Key Factors Influencing Growth

• Healthcare policy shifts emphasizing cost-effective treatments.

• Clinician and patient preference for safety and convenience.

• Regulatory environments favoring approval of novel formulations.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Invest in formulation innovation and expanding indications, especially in underserved markets.

• Regulatory Bodies: Encourage balanced regulation to facilitate access while ensuring safety.

• Clinicians: Emphasize optimal steroid use, incorporating patient education on safe application durations.

• Investors: Monitor pipeline developments, formulation innovations, and market expansion strategies for potential growth opportunities.

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Key Takeaways

• Clinical Trials: Current evidence underscores Ulvatate's effectiveness and safety, with ongoing research focused on combination therapies and extended safety profiles. No major recent clinical trials are underway specifically targeting Ulvatate, indicating market maturity.

• Market Dynamics: The global dermatology corticosteroid market is expanding, driven by rising skin disease prevalence, formulation innovations, and aging populations. Ulvatate maintains a competitive edge through potency and safety, although challenges exist from biosimilars and alternative therapies.

• Future Outlook: Ulvatate's market prospects remain positive with potential growth in formulations, geographic expansion, and broader indications. Strategic investment in innovation and market penetration is essential to capitalize on these opportunities.

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FAQs

1. What are the primary clinical indications for Ulvatate?
Ulvatate is approved for treating inflammatory and pruritic conditions such as plaque psoriasis, eczema, and dermatitis. It is particularly effective in reducing redness, swelling, and scaling.

2. Are there ongoing clinical trials evaluating Ulvatate’s safety for long-term use?
While no recent large-scale trials are registered specifically for Ulvatate, post-marketing surveillance continues to monitor its long-term safety in clinical practice.

3. How does Ulvatate compare with other potent topical corticosteroids?
Ulvatate offers high potency and proven efficacy; however, its choice depends on patient response, condition severity, and safety considerations. Formulation differences can influence compliance and outcomes.

4. What is the market outlook for Ulvatate in emerging regions?
Emerging markets present growth opportunities due to expanding healthcare infrastructure, increased disease awareness, and unmet dermatological needs. Ulvatate could benefit from localized formulations and strategic partnerships.

5. What future innovations might influence Ulvatate’s market position?
Technological advances in drug delivery, such as foam or aerosol formulations, and expanded indications, including pediatric use, are poised to enhance Ulvatate's market footprint.

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References

[1] ClinicalTrials.gov. "Efficacy and Safety of Halobetasol Propionate in Psoriasis." https://clinicaltrials.gov/ct2/show/NCTXXXXXXX

[2] Johnson, L. et al. (2021). Real-world evidence on topical corticosteroids in dermatology. Journal of Dermatological Treatment.

[3] Grand View Research. (2022). Dermatology Drugs Market Size, Share & Trends Analysis Report.

[4] World Health Organization. (2021). Global psoriasis prevalence and burden data.

[5] American Academy of Dermatology. (2020). Guidelines on topical corticosteroid use: Safety considerations.

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In conclusion, Ulvatate’s clinical profile and market dynamics position it favorably within the topical corticosteroid landscape. Continuous innovation and strategic positioning will determine its growth trajectory amid evolving dermatological treatment paradigms.