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Efficacy and Tolerability of Enstilar® in Daily Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02881346
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : December 13, 2019
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
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,

Condition or disease Intervention/treatment
Plaque Psoriasis Drug: Enstilar®

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Study Type : Observational
Actual Enrollment : 410 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational, Non-interventional, Multicenter Study on the Efficacy and Tolerability of Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients With Plaque Psoriasis Under Daily Practice Conditions
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort Intervention/treatment
Patients with psoriasis vulgaris plaques on body and/or extremities will apply Enstilar® (calcipotriol /betamethasone dipropionate (50 micrograms/g + 0.5 mg/g) cutaneous foam) once daily for up to 4 weeks, according to the approved labelling of Enstilar® in Germany.
Drug: Enstilar®
Once daily application of cutaneous foam to plaques on body and/or extremities
Other Name: calcipotriol/betamethasone dipropionate cutaneous foam

Primary Outcome Measures :
  1. Investigator Global Assessment [ Time Frame: Week 4 ]
    5-point Likert scale

  2. Percentage of total body surface area affected [ Time Frame: 4 weeks ]

  3. Absence of related adverse events (ADR) [ Time Frame: 4 weeks ]
    Proportion of patients with no ADRs

Secondary Outcome Measures :
  1. Patient Global Assessment [ Time Frame: 4 weeks ]
    5-point Likert scale

  2. PASI 50 [ Time Frame: 4 weeks ]
    Psoriasis Area and Severity Index

  3. PASI 75 [ Time Frame: 4 weeks ]
    Psoriasis Area and Severity Index

  4. Patient reported itching [ Time Frame: 4 weeks ]
    10-point scale

  5. Patient reported sleep loss [ Time Frame: 4 weeks ]
    10-point scale

  6. Patient reported erythema [ Time Frame: 4 weeks ]
    10-point scale

  7. Patient reported scaling [ Time Frame: 4 weeks ]
    10-point scale

  8. Patient reported dry skin [ Time Frame: 4 weeks ]
    10-point scale

  9. Patient reported overall treatment satisfaction [ Time Frame: 4 weeks ]
    4-point Likert scale

  10. Patient reported satisfaction with effectiveness [ Time Frame: 4 weeks ]
    4-point Likert scale

  11. Patient reported satisfaction with tolerability [ Time Frame: 4 weeks ]
    4-point Likert scale

  12. Patient reported satisfaction with convenience [ Time Frame: 4 weeks ]
    4-point Likert scale

  13. Dermatology Life Quality Index [ Time Frame: 4 weeks ]
    Standard Quality of Life Questionnaire (DLQI)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with psoriasis vulgaris plaques on trunk and/or extremities of at least mild severity for whom topical treatment with Enstilar® is planned

Inclusion Criteria:

  • ≥ 18 years of age
  • Psoriasis vulgaris
  • Lesions on trunk and/or extremities of at least mild severity
  • Treatment with Enstilar® planned
  • Signed informed consent to participate

Exclusion Criteria:

  • Enrolled in any interventional clinical trial
  • Ongoing or recent treatment with any systemic psoriasis
  • Ongoing or recent treatment with UV-therapy
  • Ongoing or previous treatment with Enstilar®
  • Psoriasis of scalp only
  • Other forms of psoriasis, e.g. erythrodermic or pustular psoriasis
  • More than 30% of surface area affected by psoriasis
  • Any contraindications or known allergies to Enstilar® or its ingredients
  • Incapacitated patients under institutionalized care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02881346

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Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein
Kiel, Germany
Sponsors and Collaborators
LEO Pharma
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Principal Investigator: Sascha Gerdes, Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein, Campus Kiel
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: LEO Pharma Identifier: NCT02881346    
Other Study ID Numbers: NIS-ENSTILAR-1295
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by LEO Pharma:
Psoriasis vulgaris
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents