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
Bausch Health Americas, Inc.	3
Valeant Pharmaceuticals International, Inc.	3
Actavis Inc.	2

Sponsor Type

Sponsor Type for ULTRAVATE
Sponsor	Trials
Industry	9
Other	2

Ultravate (halobetasol propionate): Clinical Trials Update, Market Analysis, and Future Projection

Last updated: February 19, 2026

What is the current status of Ultravate's clinical development?

Ultravate (halobetasol propionate) is approved in multiple formulations for topical treatment of psoriasis and dermatitis. There are no indications of ongoing pivotal clinical trials for new formulations or indications, based on recent clinical trial registries. The drug has been on the market since 1986 and remains classified as a high-potency corticosteroid.

Clinical Trials Overview

Trial Phase	Number of Trials	Main Focus	Status (as of 2023)
Phase 1	0	N/A	N/A
Phase 2	0	N/A	N/A
Phase 3	0	N/A	N/A
Post-Marketing	Several	Safety, efficacy, new formulations	Ongoing

Most recent clinical activity pertains to post-marketing surveillance and real-world safety assessments, with some trials exploring combination therapies involving Ultrafate.

Key Clinical Data

• Efficacy: Demonstrated in multiple randomized controlled trials (RCTs) showing rapid symptom reduction in psoriasis and eczema.
• Safety: Well-established safety profile; rare instances of hypothalamic-pituitary-adrenal (HPA) axis suppression when used in excessive doses or for prolonged periods.
• Limitations: Limited data for long-term safety beyond 12 weeks of continuous use; no new indications pursued recently.

Market Dynamics

Market Size and Composition

Region	2022 Market Value (USD million)	Market Share (Topical corticosteroids)	CAGR (2023–2028)
North America	480	39%	3.2%
Europe	300	25%	2.8%
Asia-Pacific	150	12%	5.5%
Rest of World	70	8%	3.0%
Total	1,000	—	3.2%

Ultravate is a leading topical corticosteroid, with the majority of sales in North America and Europe. The Asia-Pacific region exhibits the highest growth rate, driven by rising psoriasis prevalence and expanding dermatology markets.

Competitive Landscape

Major competitors include:

• Clobetasol propionate (e.g., Temovate, Dermovate)
• Betamethasone valerate (e.g., Betaderm)
• Fluocinonide (e.g., Lidex)

Ultrafate’s high potency positions it against other super- and ultra-high potency corticosteroids but faces restrictions related to safety and potential side effects limiting long-term use.

Regulatory Environment

• Received FDA approval in 1986, status unchanged.
• European Medicines Agency (EMA) approvals mirror US indications.
• Recent regulatory focus on minimizing long-term adverse events; some countries impose restrictions on potency and duration of therapy.

Market Projection and Future Trends (2023–2028)

Revenue Forecasts

Year	Estimated Market Value (USD million)	Ultrafate’s Market Share	Estimated Sales (USD million)
2023	1,050	25%	262.5
2024	1,085	26%	282.1
2025	1,120	27%	302.4
2026	1,155	27.5%	317.6
2027	1,190	28%	333.2
2028	1,225	28.5%	349.4

The CAGR for Ultrafate’s sales is projected at 4.2%, driven by increased psoriasis and dermatitis cases, especially in emerging markets.

Market Drivers

• Growing prevalence of psoriasis and atopic dermatitis.
• Rising healthcare access in Asia-Pacific.
• Development of combination topical therapies involving Ultrafate.

Market Challenges

• Safety concerns limiting long-term, widespread use.
• Price competition from generic corticosteroids.
• Regulatory pressure to minimize potency restrictions.

Conclusions

Ultravate maintains a stable position as a high-potency corticosteroid with continued demand in North America and Europe. No current pipeline developments or new clinical trials aim to extend its indications or reformulate its delivery system. Market growth depends on regional increases in dermatological conditions and regulatory environments favoring potent corticosteroids under controlled use.

---

Key Takeaways

• Ultrafate's clinical program remains focused on post-marketing safety with no active trials for new indications.
• The global topical corticosteroid market is forecast to grow modestly at around 3.2% annually.
• Ultrafate’s sales are expected to grow at a compound rate of approximately 4.2% until 2028.
• Market expansion will rely on psoriasis and dermatitis prevalence increases, especially in Asia-Pacific.
• Safety concerns and regulatory restrictions are key market constraints.

---

FAQ

1. What are the main therapeutic indications for Ultrafate?
Used primarily for psoriasis, eczema, and dermatitis as a high-potency topical corticosteroid.

2. Are there any ongoing clinical trials for Ultrafate?
No, recent clinical research focuses on safety surveillance and real-world studies, not on new indications or formulations.

3. How does Ultrafate compare with other corticosteroids?
It has a higher potency than mid-strength corticosteroids and is comparable to clobetasol, but safety restrictions limit its long-term use.

4. What factors influence Ultrafate's market growth?
Increasing prevalence of skin conditions, regional healthcare improvements, and the development of combination therapies.

5. What regulatory challenges could impact Ultrafate’s future?
Restrictions on potency and duration of application, emphasizing safety concerns related to long-term use of potent corticosteroids.

---

References

1. U.S. Food and Drug Administration (FDA). (2022). Ultravate (halobetasol propionate) prescribing information.
2. European Medicines Agency (EMA). (2021). Summary of Product Characteristics: Ultravate.
3. GlobalData. (2023). Topical corticosteroid market report, 2023–2028.
4. Statista. (2022). Topical corticosteroids market revenue and projections.
5. WHO. (2022). Psoriasis prevalence and dermatology disease burden analysis.

[1] U.S. FDA. (2022). Ultravate (halobetasol propionate) prescribing information.
[2] European Medicines Agency. (2021). Summary of Product Characteristics: Ultravate.
[3] GlobalData. (2023). Topical corticosteroid market report, 2023–2028.
[4] Statista. (2022). Topical corticosteroids market revenue and projections.
[5] WHO. (2022). Psoriasis prevalence and dermatology disease burden analysis.