CLINICAL TRIALS PROFILE FOR HALOBETASOL PROPIONATE

All Clinical Trials for Halobetasol Propionate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00715975 ↗	Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis	Completed	Azidus Brasil	Phase 2/Phase 3	2008-07-01	The Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly lesions in various areas of the body, preferably in the scalp, region and religious joints as elbows and knees. It occurs equally in both sexes and can appear at any age, and the mean age for the onset of the disease and around 27.3 years. The halobetasol propionate and an ultra-potent corticoid. Its chemical structure and similar to the Clobetasol corticoid this, until then classified as the most potent corticoid used worldwide in clinical practice. However, the molecular structure of Halobetasol gives it increased its activity antiinflammatory and anti-proliferative. The objective of this study is evaluating the efficacy and tolerability of the drug Halobetasol propionate cream formulation as a treatment in patients with plaque psoriasis mild to moderate, compared to the substance of similar power, Clobetasol propionate - Psorex - Cream.
NCT00802958 ↗	Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments	Completed	Padagis LLC		2003-07-01	The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.
NCT00802958 ↗	Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments	Completed	Perrigo Company		2003-07-01	The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.
NCT00803166 ↗	Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams	Completed	Padagis LLC		2004-01-01	The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.
NCT00803166 ↗	Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams	Completed	Perrigo Company		2004-01-01	The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.
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).

Clinical Trial Conditions for Halobetasol Propionate

Condition Name

Condition Name for Halobetasol Propionate
Intervention	Trials
Plaque Psoriasis	9
Healthy	4
Psoriasis	4
AKN	1

Condition MeSH

Condition MeSH for Halobetasol Propionate
Intervention	Trials
Psoriasis	14
Acne Keloid	1
Hemorrhoids	1
Eczema	1

Clinical Trial Locations for Halobetasol Propionate

Trials by Country

Trials by Country for Halobetasol Propionate
Location	Trials
United States	67
Panama	1
Ukraine	1
Poland	1
Brazil	1

Trials by US State

Trials by US State for Halobetasol Propionate
Location	Trials
California	10
Florida	7
Texas	5
New York	4
North Carolina	3

Clinical Trial Progress for Halobetasol Propionate

Clinical Trial Phase

Clinical Trial Phase for Halobetasol Propionate
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Halobetasol Propionate
Clinical Trial Phase	Trials
Completed	13
Recruiting	4
Terminated	2

Clinical Trial Sponsors for Halobetasol Propionate

Sponsor Name

Sponsor Name for Halobetasol Propionate
Sponsor	Trials
Bausch Health Americas, Inc.	5
Icahn School of Medicine at Mount Sinai	3
Sun Pharmaceutical Industries Limited	3

Sponsor Type

Sponsor Type for Halobetasol Propionate
Sponsor	Trials
Industry	25
Other	6

Halobetasol Propionate: Clinical Trials, Market Analysis, and Projections

Introduction

Halobetasol propionate is a potent topical corticosteroid widely used in the treatment of various skin conditions, including psoriasis, atopic dermatitis, and hemorrhoids. This article provides an update on recent clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

Hyperkeratotic Psoriasis

A significant clinical trial update comes from the use of halobetasol propionate in combination with tazarotene for treating hyperkeratotic psoriasis. This combination, approved by the FDA in 2019, has shown clinically meaningful, early, and sustained skin clearance in patients with moderate to severe scaling or plaque elevation. The phase 3 trials demonstrated that patients receiving the halobetasol propionate/tazarotene lotion achieved significantly greater improvements in skin clearance compared to the vehicle cohort. By week 12, 42.2% of patients with moderate to severe scaling and 41.7% with moderate to severe plaque elevation achieved a 75% improvement in the psoriasis area and severity index (IGA×BSA-75)[1].

Hemorrhoids

Another notable clinical trial involves the use of halobetasol propionate in combination with lidocaine (CITI-002) for the treatment of hemorrhoids. The Phase 2b study conducted by Citius Pharmaceuticals showed that the high dose formulation of CITI-002 provided a meaningful reduction in symptom severity compared to individual components alone. The study also validated a patient-reported outcome (PRO) instrument, which will be used in future Phase 3 trials. The treatment was well-tolerated, with no significant adverse events reported[3].

Efficacy and Safety

Comparative Studies

In comparative clinical trials, 0.05% halobetasol propionate cream has been shown to have efficacy similar to 0.05% clobetasol 17-propionate cream and 0.05% betamethasone dipropionate cream in treating acute, severe exacerbations of atopic dermatitis. These studies indicated that halobetasol propionate cream had a high success rate, with an onset of therapeutic effect within 3 days of treatment. The cream was well tolerated, with dryness of the skin and itching being the most common adverse effects[4].

Mechanism of Action

The combination of halobetasol propionate with tazarotene leverages the antiproliferative effect of corticosteroids and the gene modulation induced by retinoids. This synergy helps normalize keratinocyte differentiation and proliferation, which are key factors in the pathogenesis of psoriasis[1].

Market Analysis

Current Market Size

The global halobetasol propionate market was valued at US$ 39 million in 2023. This market is expected to grow significantly, driven by the increasing prevalence of skin conditions and the efficacy of halobetasol propionate in treating these conditions[2].

Market Projections

The market is projected to reach US$ 54 million by 2030, with a compound annual growth rate (CAGR) of 4.9% during the forecast period from 2024 to 2030. This growth is attributed to the expanding use of halobetasol propionate in various dermatological applications and the introduction of new formulations such as the combination with tazarotene and lidocaine[2][5].

Market Segmentation

The market is segmented based on type (e.g., 15g, 30g), application (e.g., hospital, clinic), and geographical regions (e.g., North America, Europe, Asia-Pacific). The report provides a detailed examination of these segments to analyze prevailing trends and key factors influencing the market[5].

Key Players and Competitors

The halobetasol propionate market includes several key players such as ULTRAVATE, LEXETTE, Glenmark Pharma, Sun Pharma, BRYHALI, PERRIGO, Duobrii, STERLING, Midas Pharma, Pfizer, Taro Pharmaceuticals, Glenwood Pharmaceuticals, and Fougera Pharmaceuticals. These companies are actively involved in the development and distribution of halobetasol propionate products, contributing to the market's growth[2].

Challenges and Opportunities

Challenges

Despite its efficacy, halobetasol propionate can have side effects such as skin dryness and itching. Additionally, the potential for systemic absorption and the risk of adrenal suppression with prolonged use are concerns that need to be addressed[4].

Opportunities

The growing demand for effective treatments for skin conditions and the development of new formulations and combinations offer significant opportunities for market growth. The validation of patient-reported outcome instruments, as seen in the CITI-002 trial, also enhances the potential for more patient-centric treatment approaches[3].

Conclusion

Halobetasol propionate remains a crucial drug in the treatment of various skin conditions, with recent clinical trials highlighting its efficacy in combination therapies. The market for halobetasol propionate is poised for significant growth, driven by increasing demand and the introduction of new formulations.

Key Takeaways

• Halobetasol propionate in combination with tazarotene shows clinically meaningful skin clearance in hyperkeratotic psoriasis.
• The combination of halobetasol propionate with lidocaine (CITI-002) is effective in reducing symptom severity in hemorrhoids.
• The global halobetasol propionate market is expected to grow at a CAGR of 4.9% from 2024 to 2030.
• Key players in the market include ULTRAVATE, LEXETTE, Glenmark Pharma, and others.
• The market is segmented by type, application, and geographical regions.

FAQs

What is halobetasol propionate used for?

Halobetasol propionate is a potent topical corticosteroid used in the treatment of various skin conditions, including psoriasis, atopic dermatitis, and hemorrhoids.

What are the recent clinical trial findings for halobetasol propionate?

Recent clinical trials have shown that halobetasol propionate in combination with tazarotene provides significant skin clearance in hyperkeratotic psoriasis and that the combination with lidocaine (CITI-002) reduces symptom severity in hemorrhoids.

What is the projected market size for halobetasol propionate by 2030?

The global halobetasol propionate market is projected to reach US$ 54 million by 2030, with a CAGR of 4.9% during the forecast period from 2024 to 2030.

Who are the key players in the halobetasol propionate market?

Key players include ULTRAVATE, LEXETTE, Glenmark Pharma, Sun Pharma, BRYHALI, PERRIGO, Duobrii, STERLING, Midas Pharma, Pfizer, Taro Pharmaceuticals, Glenwood Pharmaceuticals, and Fougera Pharmaceuticals.

What are the common side effects of halobetasol propionate?

Common side effects include skin dryness and itching. Prolonged use can also lead to systemic absorption and the risk of adrenal suppression.

References

1. Halobetasol Propionate, Tazarotene Lotion Demonstrates Clinically Significant Skin Clearance in Hyperkeratotic Psoriasis. HCPLive.
2. Global Halobetasol Propionate Market Research. Valuates Reports.
3. Citius Pharmaceuticals Announces Positive Results from the Phase 2b Study of Halo-Lido (CITI-002) for the Treatment of Hemorrhoids. PR Newswire.
4. Double-blind, comparative clinical trials with halobetasol propionate cream. PubMed.
5. Global Halobetasol Propionate Market Size, Trends and Projections. Market Research Intellect.

Last updated: 2025-01-01