CLINICAL TRIALS PROFILE FOR DESONIDE

All Clinical Trials for desonide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01542138 ↗	Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation	Completed	Hospital Central "Dr. Ignacio Morones Prieto"	Phase 4	2011-07-01	Axillary hyperpigmentation is a frequent consultation in dark skin populations although its exact prevalency is unknown. Currently, there are not studies about physiopathology and treatment for this entity. The objective is to evaluate the depigmenting effect of topical 4% niacinamide versus 0.05% desonide in axillary hyperpigmentation. At least 30 axillas with hyperpigmentation in individuals of phototype III-V, aged 18-50 years are going to be randomly assigned to receive niacinamide, desonide or placebo daily. No hygienic habits will not be modified. Volunteers will be evaluated at baseline and for 9 weeks, by means of histological, histochemical and immunohistochemistry analysis, as well as Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography control.
NCT01542138 ↗	Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation	Completed	Universidad Autonoma de San Luis Potosí	Phase 4	2011-07-01	Axillary hyperpigmentation is a frequent consultation in dark skin populations although its exact prevalency is unknown. Currently, there are not studies about physiopathology and treatment for this entity. The objective is to evaluate the depigmenting effect of topical 4% niacinamide versus 0.05% desonide in axillary hyperpigmentation. At least 30 axillas with hyperpigmentation in individuals of phototype III-V, aged 18-50 years are going to be randomly assigned to receive niacinamide, desonide or placebo daily. No hygienic habits will not be modified. Volunteers will be evaluated at baseline and for 9 weeks, by means of histological, histochemical and immunohistochemistry analysis, as well as Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography control.
NCT00828412 ↗	Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis	Completed	Promius Pharma, LLC	Phase 4	2009-03-01	This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.
NCT00608777 ↗	Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)	Terminated	Genentech, Inc.	Phase 4	2008-01-01	The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.
NCT00608777 ↗	Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)	Terminated	Derm Research, PLLC	Phase 4	2008-01-01	The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.
NCT00690833 ↗	Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis	Completed	Wake Forest University	Phase 4	2007-08-01	The purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug Administration (FDA) for atopic dermatitis.

Clinical Trial Conditions for desonide

Condition Name

Condition Name for desonide
Intervention	Trials
Atopic Dermatitis	2
Atopic Dermatitis Eczema	1
Dermatitis, Atopic	1
Eczema	1

Condition MeSH

Condition MeSH for desonide
Intervention	Trials
Eczema	4
Dermatitis, Atopic	4
Dermatitis	4
Psoriasis	2

Clinical Trial Locations for desonide

Trials by Country

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−

Trials by Country for desonide
Location	Trials
United States	11
Mexico	1

Trials by US State

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−

Trials by US State for desonide
Location	Trials
North Carolina	3
California	1
Tennessee	1
Massachusetts	1
Texas	1

Clinical Trial Progress for desonide

Clinical Trial Phase

Clinical Trial Phase for desonide
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for desonide
Clinical Trial Phase	Trials
Completed	4
Unknown status	2
Recruiting	1

Clinical Trial Sponsors for desonide

Sponsor Name

Sponsor Name for desonide
Sponsor	Trials
Wake Forest University	1
Promius Pharma, LLC	1
Hospital Central "Dr. Ignacio Morones Prieto"	1

Sponsor Type

Sponsor Type for desonide
Sponsor	Trials
Other	6
Industry	5

Desonide: Clinical Trials, Market Analysis, and Projections

Introduction to Desonide

Desonide is a low-potency topical corticosteroid widely used in the treatment of steroid-responsive dermatoses, including atopic dermatitis. Its favorable safety profile makes it an ideal treatment option for patients of all ages.

Clinical Trials and Efficacy

Phase III Clinical Trials for Atopic Dermatitis

Desonide has undergone extensive clinical testing, particularly in the treatment of atopic dermatitis. Two phase III clinical trials conducted by SkinMedica, Inc. involved 582 pediatric patients aged 3 months to 18 years with mild to moderate atopic dermatitis. Patients were treated with either Desonate HydroGel 0.05% or a placebo twice daily for 4 weeks. The results demonstrated a significant treatment effect for Desonate HydroGel in both primary and secondary endpoints, highlighting its efficacy in reducing symptoms of atopic dermatitis[1][4].

Clinical Endpoints and Safety

The clinical trials defined treatment success as achieving clear or almost clear on the Investigator’s Global Severity Score (IGSS) with at least a 2-point change from the baseline. The studies showed that 44% and 28% of patients treated with Desonate Gel achieved treatment success in the two trials, respectively, compared to 14% and 6% in the placebo groups[4].

Adverse Events and Safety Profile

Adverse events observed during these trials were generally mild. Local adverse events such as application site burning, rash, and pruritus were reported in a small percentage of patients. Systemic adverse events, including headache, were also noted but were not significantly higher than in the placebo group. The safety profile of desonide, including its low risk of adrenal suppression, makes it a preferred option for long-term use[4].

Market Analysis and Projections

Current Market Size and Growth

The global market for desonide was estimated to be worth US$ 782 million in 2023. This market is forecasted to grow to US$ 1150.5 million by 2030, with a compound annual growth rate (CAGR) of 5.7% during the forecast period of 2024-2030[2][5].

Key Players and Market Segmentation

The desonide market is dominated by several key players, including Galderma, Taro, Aleor Dermaceuticals, Encube Ethicals, Glenmark Pharmaceuticals, Perrigo, Teligent Pharma, and Huapont Pharma. The market is segmented by type (cream, lotion, ointment, hydrogel, and foam), application (atopic dermatitis, eczema, psoriasis, etc.), and region (North America, Europe, Asia Pacific, Middle East & Africa, and Latin America)[2][5].

Regional Analysis

The market analysis includes a detailed regional breakdown, highlighting the revenue share and current trends in each major region. North America, Europe, and Asia Pacific are significant contributors to the global desonide market, driven by increasing demand for effective dermatological treatments and a growing awareness of skin health[5].

Market Trends and Drivers

The growth of the desonide market is driven by several factors, including the increasing prevalence of skin conditions such as atopic dermatitis and eczema, advancements in formulation technology (e.g., hydrogel and foam preparations), and the expanding aging population which is more susceptible to skin disorders. Additionally, the rise in healthcare spending and the availability of generic versions of desonide contribute to the market's expansion[3][5].

Formulations and Patient Tolerability

Variety of Formulations

Desonide is available in various formulations, including cream, lotion, ointment, hydrogel, and foam. These different formulations enhance patient tolerability and versatility, allowing for better adherence to treatment regimens. The hydrogel and foam preparations, in particular, have been well-received due to their ease of application and minimal side effects[3].

Patient Compliance

The development of these various formulations has improved patient compliance. For instance, the hydrogel formulation, such as Desonate HydroGel 0.05%, is alcohol-free and aqueous, making it more comfortable for patients, especially children, to use[1].

Future Prospects and Opportunities

Emerging Markets

Emerging markets in Asia Pacific and Latin America are expected to play a significant role in the future growth of the desonide market. Increasing healthcare infrastructure and rising disposable incomes in these regions are driving the demand for dermatological treatments[5].

Technological Advancements

Advancements in delivery systems and formulation technologies are expected to further enhance the efficacy and safety of desonide. Research into new vehicles and delivery methods could expand the range of applications for desonide, potentially treating other skin conditions more effectively[3].

Key Takeaways

• Clinical Efficacy: Desonide has demonstrated significant efficacy in treating mild to moderate atopic dermatitis in clinical trials.
• Market Growth: The global desonide market is projected to grow from US$ 782 million in 2023 to US$ 1150.5 million by 2030, with a CAGR of 5.7%.
• Key Players: Major players include Galderma, Taro, Aleor Dermaceuticals, and others.
• Formulations: Various formulations such as cream, lotion, ointment, hydrogel, and foam enhance patient tolerability.
• Future Prospects: Emerging markets and technological advancements are expected to drive future growth.

FAQs

What is desonide used for?

Desonide is a low-potency topical corticosteroid used primarily for the treatment of steroid-responsive dermatoses, including atopic dermatitis and eczema.

What are the common formulations of desonide?

Desonide is available in cream, lotion, ointment, hydrogel, and foam formulations.

What is the projected market size of desonide by 2030?

The global desonide market is forecasted to reach US$ 1150.5 million by 2030.

Who are the key players in the desonide market?

Key players include Galderma, Taro, Aleor Dermaceuticals, Encube Ethicals, Glenmark Pharmaceuticals, Perrigo, Teligent Pharma, and Huapont Pharma.

What are the main drivers of the desonide market growth?

The growth is driven by the increasing prevalence of skin conditions, advancements in formulation technology, and the expanding aging population.

Are there any significant side effects associated with desonide?

Local adverse events such as application site burning, rash, and pruritus are reported, but systemic side effects are rare and generally mild.

Sources

1. Clinical Trial News - Advances in Skin & Wound Care. Lippincott Williams & Wilkins, Inc., June 2006.
2. Desonide - Market, Report Size, Worth, Revenue, Growth, Industry. Valuates Reports.
3. Desonide: a review of formulations, efficacy and safety. PubMed.
4. Desonate™ (desonide) Gel 0.05% Rx Only. FDA.
5. Desonide Market Report 2024 (Global Edition). Cognitive Market Research.