CLINICAL TRIALS PROFILE FOR BETAMETHASONE DIPROPIONATE

All Clinical Trials for Betamethasone Dipropionate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00216827 ↗	Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis	Completed	LEO Pharma	Phase 3	2004-11-01	The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis. The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.
NCT00216840 ↗	Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis	Completed	LEO Pharma	Phase 3	2004-12-01	The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis. The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.
NCT00216879 ↗	Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis	Completed	LEO Pharma	Phase 3	2005-02-01	The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel. The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.
NCT00216892 ↗	Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris	Completed	LEO Pharma	Phase 4	2005-04-01	Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with: 1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream 2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends 3. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream The objective is to compare the efficacy and safety of the different treatment regimens
NCT00243464 ↗	Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis	Completed	LEO Pharma	Phase 3	2005-09-01	The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment. Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.

Clinical Trial Conditions for Betamethasone Dipropionate

Condition Name

Condition Name for Betamethasone Dipropionate
Intervention	Trials
Psoriasis Vulgaris	23
Psoriasis	10
Plaque Psoriasis	7
Psoriasis of Scalp	4

Condition MeSH

Condition MeSH for Betamethasone Dipropionate
Intervention	Trials
Psoriasis	51
Lichen Planus, Oral	2
Lichen Planus	2
Syndrome	2

Clinical Trial Locations for Betamethasone Dipropionate

Trials by Country

Trials by Country for Betamethasone Dipropionate
Location	Trials
United States	137
Canada	20
United Kingdom	17
France	14
Japan	13

Trials by US State

Trials by US State for Betamethasone Dipropionate
Location	Trials
Texas	12
California	10
Florida	9
Indiana	8
North Carolina	7

Clinical Trial Progress for Betamethasone Dipropionate

Clinical Trial Phase

Clinical Trial Phase for Betamethasone Dipropionate
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Betamethasone Dipropionate
Clinical Trial Phase	Trials
Completed	52
Unknown status	7
Not yet recruiting	3

Clinical Trial Sponsors for Betamethasone Dipropionate

Sponsor Name

Sponsor Name for Betamethasone Dipropionate
Sponsor	Trials
LEO Pharma	34
Psoriasis Treatment Center of Central New Jersey	4
Prosoft Clinical	3

Sponsor Type

Sponsor Type for Betamethasone Dipropionate
Sponsor	Trials
Industry	65
Other	24

Betamethasone Dipropionate: Clinical Trials, Market Analysis, and Projections

Introduction

Betamethasone dipropionate is a potent corticosteroid used to treat various skin conditions, including psoriasis, eczema, and other inflammatory dermatoses. This article delves into the clinical trials, market analysis, and projections for this drug, providing a comprehensive overview of its efficacy, market dynamics, and future outlook.

Clinical Trials and Efficacy

Overview of Clinical Trials

Clinical trials have been instrumental in establishing the efficacy and safety of betamethasone dipropionate. One notable study published on PubMed involved a multicenter, evaluator-blind, parallel group trial comparing a new formulation of betamethasone dipropionate 0.05% cream (augmented formulation) with fluocinonide 0.05% cream in patients with moderate to severe psoriasis. The results significantly favored betamethasone dipropionate, showing improvements in signs of erythema, induration, and scaling, as well as positive global evaluations from both physicians and patients after 14 days of treatment[3].

Safety Profile

The safety profile of betamethasone dipropionate has been favorable in clinical trials. In the aforementioned study, no patients on the betamethasone dipropionate augmented formulation had to discontinue treatment due to adverse experiences, whereas three patients on fluocinonide did. This indicates a relatively safe and well-tolerated profile for betamethasone dipropionate[3].

Market Analysis

Market Size and Growth

The betamethasone dipropionate market has experienced rapid growth in recent years and is expected to continue this trend. According to market research, the market is poised for significant development from 2023 to 2031, driven by positive market dynamics and anticipated continued expansion. The market size is segmented based on type (purity levels), application (medicine, chemical, other), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Key Drivers

Several factors are driving the growth of the betamethasone dipropionate market:

• Increasing Prevalence of Dermatological Diseases: The rising incidence of skin conditions such as psoriasis and eczema is a major driver. For instance, in Europe, 185 million individuals were affected by dermatological conditions in 2021[5].
• Market Penetration: The market is seeing increased penetration at both national and regional levels, particularly in North America and Europe[2][5].
• Product Innovations: Pharmaceutical companies are launching new formulations and products, such as Lupin's launch of Betamethasone Dipropionate Ointment USP, 0.05%, which is an alternative to betamethasone acetate[5].

Regional Analysis

The market is dominated by North America, which holds a significant market share due to the high use of intramuscular suspensions for various treatments, including ophthalmic diseases. Europe is expected to be the second-largest region, driven by the increasing prevalence of dermatological diseases[5].

Market Segmentation

By Type

The market is segmented based on the purity levels of betamethasone dipropionate, including purity levels of 95%, 96%, 97%, 98%, and 99%. This segmentation helps in understanding the different quality standards and their market implications[2].

By Application

The primary application of betamethasone dipropionate is in the medical sector, particularly for treating dermatological conditions. Other applications include chemical and miscellaneous uses[2].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to dominate the market due to the increasing number of hospital pharmacies and the preference for prescription medications through these channels[5].

Projections and Future Outlook

Growth Rate

The betamethasone dipropionate market is expected to exhibit strong growth rates from 2023 to 2031. The comprehensive market report forecasts a substantial expansion, driven by the increasing prevalence of diseases and the launch of new formulations[2].

Market Opportunities

The market presents several opportunities, including:

• Expanding into New Markets: There is potential for growth in regions with increasing healthcare spending and a rising incidence of dermatological diseases.
• Product Innovations: Continuous innovation in formulations and delivery methods can attract more consumers and expand market share[2].

Challenges

Despite the positive outlook, the market faces some challenges:

• Regulatory Hurdles: Strict regulatory environments can slow down the approval and launch of new products.
• Competition: The presence of alternative treatments and generic versions can pose a challenge to market growth[2].

Key Takeaways

• Clinical Efficacy: Betamethasone dipropionate has shown significant efficacy in treating moderate to severe psoriasis and other skin conditions.
• Market Growth: The market is expected to grow substantially from 2023 to 2031, driven by increasing disease prevalence and product innovations.
• Regional Dominance: North America and Europe are expected to be the leading regions in the market.
• Segmentation: The market is segmented by type, application, and distribution channel, with hospital pharmacies dominating the distribution segment.

FAQs

What is betamethasone dipropionate used for?

Betamethasone dipropionate is primarily used to treat various skin conditions, including psoriasis, eczema, and other inflammatory dermatoses.

What are the key drivers of the betamethasone dipropionate market?

The key drivers include the increasing prevalence of dermatological diseases, market penetration, and product innovations.

Which region dominates the betamethasone dipropionate market?

North America dominates the market, followed by Europe.

What are the main challenges facing the betamethasone dipropionate market?

The main challenges include regulatory hurdles and competition from alternative treatments and generic versions.

What is the expected growth rate of the betamethasone dipropionate market from 2023 to 2031?

The market is expected to exhibit strong growth rates, driven by positive market dynamics and anticipated continued expansion.

Sources

1. Memorial Sloan Kettering Cancer Center - Betamethasone (Topical)[1]
2. Market Research Intellect - Betamethasone Dipropionate Market Size, Scope And Forecast Report[2]
3. PubMed - A controlled clinical trial of a new formulation of betamethasone dipropionate[3]
4. ClinicalTrials.gov - NCT03331523[4]
5. Coherent Market Insights - Betamethasone Acetate Market Size, Trends and Forecast to 2030[5]