CLINICAL TRIALS PROFILE FOR CLOBETASOL PROPIONATE

All Clinical Trials for CLOBETASOL PROPIONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00437255 ↗	Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis	Completed	Galderma Laboratories, L.P.	Phase 4	2006-08-01	Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
NCT00288769 ↗	Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis	Completed	Soroka University Medical Center	N/A	2006-03-01	Background: Recurrent aphthous stomatitis is a common phenomenon in Primary Medicine.Frequency of the phenomenon can be as high as 25% of the general population and the recurrence of the problem can be up to 50%.Different approaches for treatment are described: treatment with various natural vitamins , local ointments , disinfectant agents for local treatment , local antibiotic ointments , NSAID, local cortisone-steroids , and even medication on the basis of immune-depressants of the immune system and systematic steroids . Methods: A double-blind study of daily administration of sublingual Vitamin B12 tablets manufactured by Solgar (each tablet containing 1000 mcg. of Vitamin B12) opposed to placebo tablets. Purpose of the research: To investigate the effect of Vitamin B12 on the frequency of recurrent canker sores of the mouth (RAS). Study hypothesis: Treatment with vitamin B12 will reduce the recurrence rate and will diminish the symptomatology of RAS episodes.
NCT00436540 ↗	A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam	Completed	Galderma Laboratories, L.P.	Phase 4	2006-03-01	The primary objective of this study is to evaluate the efficacy and safety of clobetasol propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.
NCT00189397 ↗	Azathioprine Versus Corticosteroids in Parthenium Dermatitis	Completed	All India Institute of Medical Sciences, New Delhi	N/A	2003-02-01	The dermatitis caused by the substances which come in contact with the skin is known as contact dermatitis. When such a reaction is caused by the agents suspended in the air, it is called air-borne contact dermatitis (ABCD). Parthenium hysterophorus at present is the commonest cause of ABCD in India though in some cases other plants have also been found to cause ABCD. Parthenium dermatitis is one of the major health problems in dermatology in our country. Though it has very little mortality, the disease normally continues to persist with variable remissions and relapses causing great distress and morbidity. Corticosteroids, topical and systemic have been the mainstay of the treatment so far. Therefore, the patients with ABCD who have to take corticosteroids for long periods of time tend to develop severe and sometimes irreversible side effects of the therapy. Azathioprine is an immunosuppressive drug which acts by inhibiting the T lymphocytes. In our previous studies we have been able to induce remissions in these patients with azathioprine used as daily as well as monthly bolus dose, without having to use systemic corticosteroids. The side effect with azathioprine in these studies were almost absent. We have therefore planned to study the therapeutic efficacy of azathioprine weekly pulse doses versus daily azathioprine in achieving remissions in patients having Parthenium dermatitis and to monitor the side effects of both the regimens.

Clinical Trial Conditions for CLOBETASOL PROPIONATE

Condition Name

Condition Name for CLOBETASOL PROPIONATE
Intervention	Trials
Psoriasis	13
Vulvar Lichen Sclerosus	6
Oral Lichen Planus	6
Alopecia Areata	4

Condition MeSH

Condition MeSH for CLOBETASOL PROPIONATE
Intervention	Trials
Psoriasis	23
Lichen Planus	8
Lichen Sclerosus et Atrophicus	8
Lichen Planus, Oral	8

Clinical Trial Locations for CLOBETASOL PROPIONATE

Trials by Country

+

−

Trials by Country for CLOBETASOL PROPIONATE
Location	Trials
United States	114
France	9
Germany	8
Canada	6
Brazil	6

Trials by US State

+

−

Trials by US State for CLOBETASOL PROPIONATE
Location	Trials
California	13
Texas	11
New York	9
Florida	5
North Carolina	5

Clinical Trial Progress for CLOBETASOL PROPIONATE

Clinical Trial Phase

Clinical Trial Phase for CLOBETASOL PROPIONATE
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	15
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for CLOBETASOL PROPIONATE
Clinical Trial Phase	Trials
Completed	47
Unknown status	7
Recruiting	7

Clinical Trial Sponsors for CLOBETASOL PROPIONATE

Sponsor Name

Sponsor Name for CLOBETASOL PROPIONATE
Sponsor	Trials
Galderma Laboratories, L.P.	7
GlaxoSmithKline	5
Stiefel, a GSK Company	4

Sponsor Type

Sponsor Type for CLOBETASOL PROPIONATE
Sponsor	Trials
Other	47
Industry	44
NIH	1

Clobetasol Propionate: Clinical Trials, Market Analysis, and Projections

Introduction

Clobetasol propionate, a potent corticosteroid, has been gaining significant attention in the ophthalmic field for its efficacy in treating inflammation and pain associated with cataract surgery and other ocular procedures. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Phase 3 Trials

Several Phase 3 clinical trials have been conducted to evaluate the efficacy and safety of clobetasol propionate ophthalmic nanoemulsion or suspension.

• CLOSE-1 and CLOSE-2 Trials: These trials, sponsored by Salvat, involved patients undergoing cataract surgery. The studies demonstrated that clobetasol propionate ophthalmic nanoemulsion 0.05% provided rapid relief from inflammation and pain, with improvements visible as early as four days post-surgery. These trials also showed faster visual acuity improvement and a favorable safety profile[1][3].

• CPN-302 Trial: Conducted by Eyenovia, this Phase 3 study (CPN-302) led to FDA approval for treating inflammation and pain following ocular surgery. The results highlighted the drug's efficacy in providing rapid relief and improving visual acuity, along with a desirable safety profile[3].

• CPN-303 Trial: This trial, conducted in Chinese subjects by Formosa Pharmaceuticals and its licensee Grand Pharma, evaluated the efficacy of clobetasol propionate ophthalmic nanosuspension (APP13007) in treating post-cataract surgery inflammation and pain. The trial reported successful top-line results, supporting the drug's approval and launch in the United States and other regions[4].

Pediatric Population

A new Phase 3 trial (CLOSE-3) is currently recruiting participants to evaluate the efficacy and safety of clobetasol propionate ophthalmic nanoemulsion 0.05% in the pediatric population undergoing cataract surgery. This trial aims to expand the drug's indications to include younger patients[1].

Market Analysis

Market Growth

The clobetasol propionate market is projected to witness significant growth from 2023 to 2030. This growth is driven by the increasing demand for effective post-operative ophthalmic medications, the expanding aging population, and advancements in ophthalmic technology[2].

Competitive Landscape

The market is competitive, with several companies involved in the development and commercialization of clobetasol propionate formulations. Key players include Eyenovia, Salvat, and Formosa Pharmaceuticals, each with their own distribution models and market strategies. Eyenovia, for instance, has launched clobetasol commercially through its pharmacy partner Medvantx and directly via EyenoviaRx.com, aiming to streamline accessibility for prescribers[3].

Regional Outlook

The market is segmented across various regions, including Latin America, Europe, Asia Pacific, Africa, and the Middle East. The Asia Pacific region, particularly China, is expected to be a significant market due to the large population and growing healthcare needs. Grand Pharma has obtained exclusive rights for the commercialization of APP13007 (clobetasol propionate nanosuspension) in Mainland China, Hong Kong, and Macau[2][4].

Market Projections

Market Size and Share

The global clobetasol propionate market is anticipated to grow substantially, driven by the increasing adoption of the drug in post-operative ophthalmic care. The market size is expected to increase from its current value to a significant figure by 2030, with a notable CAGR during the forecast period[2][5].

Revenue and Financial Impact

The commercial launch of clobetasol propionate by Eyenovia and other companies is expected to drive revenue growth. Investors are keenly watching the initial sales figures and market uptake in the coming quarters. The financial health of companies like Eyenovia will be significantly impacted by the success of clobetasol propionate, potentially driving revenue growth and improving their market position[3].

Distribution and Accessibility

The distribution model, including partnerships with pharmacy networks and direct-to-consumer sales, is designed to enhance accessibility. This streamlined approach is expected to drive adoption among physicians and patients, contributing to the market growth of clobetasol propionate[3].

Key Takeaways

• Clinical Efficacy: Clobetasol propionate has demonstrated rapid relief from inflammation and pain, improved visual acuity, and a favorable safety profile in multiple Phase 3 trials.
• Market Growth: The market is projected to grow significantly from 2023 to 2030, driven by increasing demand and expanding aging populations.
• Competitive Landscape: Key players like Eyenovia, Salvat, and Formosa Pharmaceuticals are competing in the market with different distribution strategies.
• Regional Focus: The Asia Pacific region, particularly China, is expected to be a significant market due to its large population and growing healthcare needs.
• Financial Impact: The success of clobetasol propionate could significantly impact the financial health of companies involved, driving revenue growth and market position.

FAQs

What is clobetasol propionate used for in ophthalmology?

Clobetasol propionate is used to treat inflammation and pain associated with cataract surgery and other ocular procedures.

What are the key findings from the Phase 3 trials of clobetasol propionate?

The Phase 3 trials have shown that clobetasol propionate provides rapid relief from inflammation and pain, improves visual acuity, and has a favorable safety profile.

Which companies are involved in the commercialization of clobetasol propionate?

Key companies involved include Eyenovia, Salvat, and Formosa Pharmaceuticals.

What is the projected market growth for clobetasol propionate?

The market is expected to grow significantly from 2023 to 2030, driven by increasing demand and an expanding aging population.

How is clobetasol propionate distributed?

Clobetasol propionate is distributed through pharmacy networks and direct-to-consumer sales, aiming to enhance accessibility for prescribers and patients.

Sources

1. ClinicalTrials.gov: Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery.
2. Stratagem Market Insights: Clobetasol Propionate Market Insight, Size, Share, Growth, Up-To-Date Key Trends, Regional Outlook, and Forecast - 2030.
3. StockTitan: Eyenovia Announces Presentation of Phase 3 Clobetasol Study Results at the American Academy of Ophthalmology (AAO) 2024 Expo.
4. BioSpace: Formosa Pharmaceuticals Announces Successful Top-Line Results From CPN-303, a Phase 3 Trial in Chinese Subjects for the Treatment of Inflammation and Pain After Cataract Surgery.
5. QYResearch: Global Clobetasol Propionate API Market Research Report 2024.