CLINICAL TRIALS PROFILE FOR ENSTILAR

All Clinical Trials for Enstilar

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02858713 ↗	Adherence in Topical Treatment of Psoriasis	Completed	Odense University Hospital	Phase 4	2017-01-09	Medical adherence to topical corticosteroid products in psoriasis patients is a main determinant for poor treatment effect. The investigators aim to test if a multifaceted intervention delivered in an app (MyPso QualityCareTM owned by Leo Pharma) for smartphones combined with an Electronic Monitor (EM) (Teslo) can improve medical adherence among psoriasis patients treated with a topical calcipotriol/betamethasone dipropionate foam combination (Cal/BD) (Enstilar©). The study is classified as a phase 4 study, since it is studied if improved use of Enstilar© results in improved treatment outcomes. Link to published study protocol: https://bmcdermatol.biomedcentral.com/articles/10.1186/s12895-018-0071-3 Link to published results from the study: https://onlinelibrary.wiley.com/doi/abs/10.1111/bjd.16667
NCT02881346 ↗	Efficacy and Tolerability of Enstilar® in Daily Practice	Completed	LEO Pharma		2016-09-01	This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice with regards to effectiveness and convenience of application to psoriasis plaques on body and extremities. In addition the profiles of patients prescribed Enstilar® will be described, and preceeding, concomitant and follow-up management will be mapped. The study will be conducted in about 100 dermatology clinics all over Germany,
NCT02935582 ↗	PSOREAL - Managing PSOriasis in the REAL World	Completed	LEO Pharma		2017-01-01	Multinational real-life study of current psoriasis treatment strategies, topical treatment patterns and treatment outcomes of these treatments, including the newly introduced calcipotriol/betamethasone dipropionate aerosol foam fixed combination product Enstilar® (calcipotriol/betamethasone dipropionate).
NCT03080545 ↗	Enstilar in Combination With Biologic Agents	Completed	LEO Pharma	Phase 4	2017-05-01	Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.
NCT03080545 ↗	Enstilar in Combination With Biologic Agents	Completed	Psoriasis Treatment Center of Central New Jersey	Phase 4	2017-05-01	Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.
NCT03441789 ↗	Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis	Completed	L.H. Kircik, M.D.	Phase 4	2017-09-18	This study seeks to show whether there is a benefit of prescribing Enstilar with Otezla in the treatment of patients with moderate plaque type psoriasis. Subjects will be randomized to study treatment at a 1:1 ratio of Otezla plus Enstilar foam versus Otezla plus vehicle foam.

Clinical Trial Conditions for Enstilar

Condition Name

Condition Name for Enstilar
Intervention	Trials
Psoriasis	7
Plaque Psoriasis	4
Psoriasis Vulgaris	3
Nail Psoriasis	2

Condition MeSH

Condition MeSH for Enstilar
Intervention	Trials
Psoriasis	16
Connective Tissue Diseases	1
Erythema Multiforme	1
Skin Diseases, Papulosquamous	1

Clinical Trial Locations for Enstilar

Trials by Country

Trials by Country for Enstilar
Location	Trials
United States	27
Denmark	2
Germany	1
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for Enstilar
Location	Trials
Kentucky	4
New Jersey	4
New York	2
South Carolina	2
California	2

Clinical Trial Progress for Enstilar

Clinical Trial Phase

Clinical Trial Phase for Enstilar
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Enstilar
Clinical Trial Phase	Trials
Completed	8
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for Enstilar

Sponsor Name

Sponsor Name for Enstilar
Sponsor	Trials
LEO Pharma	4
Psoriasis Treatment Center of Central New Jersey	4
Derm Research, PLLC	2

Sponsor Type

Sponsor Type for Enstilar
Sponsor	Trials
Other	14
Industry	8

Enstilar: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Enstilar

Enstilar, developed by LEO Pharma, is a topical aerosol spray foam containing calcipotriol monohydrate and betamethasone dipropionate. It is designed to treat psoriasis vulgaris, particularly stable plaque psoriasis, and offers an improved formulation over the existing Daivobet ointment.

Clinical Trials Overview

Phase 3 Trials in China

Recent clinical trials conducted in China have shown promising results for Enstilar. A Phase 3 trial involving 604 adult Chinese subjects with stable plaque psoriasis compared the efficacy and safety of Enstilar against Daivobet ointment. The trial demonstrated that Enstilar was superior to Daivobet in the primary endpoint, reducing the severity and extent of stable plaque psoriasis[2][4].

Efficacy and Safety

The trial achieved both primary and secondary endpoints, with Enstilar showing improved efficacy in reducing the Psoriasis Area and Severity Index (PASI) and the Investigator Global Assessment (IGA) scores. The treatment was well tolerated, and its safety profile was consistent with previous trial findings[1][4].

Global Clinical Trials

Enstilar has also been evaluated in other clinical trials globally. The PSO-FAST study, a pivotal Phase III trial, and the Phase 2 MUSE safety profile study, supported its approval in the European Union. These studies showed that over half of the patients treated with Enstilar were "Clear" or "Almost Clear" by Week 4, and more than half achieved a 75% improvement in PASI scores from baseline[5].

Market Analysis

Current Market Presence

Enstilar is already authorized in the EU for the treatment of psoriasis vulgaris in adults for up to four weeks and as a long-term maintenance treatment for those who have responded to the initial treatment. It also holds approvals in other markets worldwide[1][5].

Expansion to China

LEO Pharma has submitted a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) for Enstilar, targeting the treatment of adult patients with plaque psoriasis. China is expected to become the largest market for Enstilar if approved, given the estimated seven million adult patients living with plaque psoriasis in the country[2][4].

Global Strategy

The submission of the NDA in China is part of LEO Pharma’s global strategy to expand its dermatology portfolio. If approved, China would join 50 other markets where Enstilar is already approved, further solidifying LEO Pharma’s position in the global dermatology market[4].

Market Projections

Growth Potential

The approval of Enstilar in China is expected to significantly boost LEO Pharma’s revenue, given the large patient population and the growing demand for effective dermatological treatments. China’s dermatology market is rapidly expanding, and Enstilar’s unique formulation and proven efficacy make it a strong contender in this market[4].

Competitive Advantage

Enstilar’s superiority over Daivobet ointment in clinical trials, combined with its convenient spray foam application, positions it as a preferred treatment option for patients and healthcare providers. This could lead to a significant market share gain in the psoriasis treatment market[1][5].

Patient Impact

Quality of Life Improvement

The clinical trials have shown that Enstilar can significantly improve the quality of life for patients with plaque psoriasis. Professor Zhang Jianzhong from Peking University People’s Hospital noted that Enstilar has the potential to improve the quality of life for millions of Chinese patients living with plaque psoriasis[1][4].

Convenience and Efficacy

Enstilar’s spray foam formulation makes it easier to apply compared to traditional ointments, enhancing patient compliance. The improved efficacy and safety profile further support its potential to become a leading treatment option for psoriasis[5].

Regulatory Status

Approval Process

The NDA submission in China is currently under review by the Center for Drug Evaluation (CDE). The regulatory review process is anticipated to be completed in the first half of 2026[2][4].

Existing Approvals

Enstilar has already received scientific approval in the European Union and has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of psoriasis vulgaris[5].

Key Takeaways

• Clinical Efficacy: Enstilar has demonstrated superior efficacy over Daivobet ointment in reducing the severity and extent of stable plaque psoriasis in clinical trials.
• Market Expansion: The submission of the NDA in China marks a significant step in LEO Pharma’s global strategy, with China potentially becoming the largest market for Enstilar.
• Patient Benefits: Enstilar offers improved convenience and efficacy, enhancing patient compliance and quality of life.
• Regulatory Status: The NDA is under review in China, with approval anticipated in the first half of 2026.

FAQs

What is Enstilar used for?

Enstilar is used for the treatment of psoriasis vulgaris, particularly stable plaque psoriasis, in adult patients.

What are the active ingredients in Enstilar?

The active ingredients in Enstilar are calcipotriol monohydrate and betamethasone dipropionate.

How does Enstilar compare to Daivobet ointment?

Enstilar has shown superior efficacy to Daivobet ointment in clinical trials, reducing the severity and extent of stable plaque psoriasis more effectively.

Is Enstilar approved in China?

Enstilar is currently under regulatory review in China, with the NDA submitted to the National Medical Products Administration (NMPA).

What is the expected regulatory timeline for Enstilar in China?

The regulatory review process in China is anticipated to be completed in the first half of 2026.

How does Enstilar improve patient quality of life?

Enstilar improves patient quality of life by providing a convenient and effective treatment option that reduces the severity of plaque psoriasis, thereby enhancing patient compliance and overall well-being.

Sources

1. PMLiVE: LEO Pharma shares positive phase 3 results for Enstilar in stable plaque psoriasis.
2. Pharmaceutical Technology: LEO Pharma announces Enstilar NDA submission for plaque psoriasis.
3. Health Products and Food Branch Inspectorate: Regulatory Decision Summary for ENSTILAR.
4. BioSpace: LEO Pharma Submits New Drug Application for Enstilar for Adults with Plaque Psoriasis in China.
5. European Pharmaceutical Review: Enstilar receives scientific approval in the EU for psoriasis.

Last updated: 2025-01-03