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OpenTrials
Completed

NCT Number: NCT02881346

Efficacy and Tolerability of Enstilar® in Daily Practice

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,

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Key information

Conditions

Plaque Psoriasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein

Kiel, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enstilar®

Drug

Once daily application of cutaneous foam to plaques on body and/or extremities

Other names: calcipotriol/betamethasone dipropionate cutaneous foam

Primary outcomes

  1. Investigator Global Assessment

    Time frame: Week 4

    5-point Likert scale

  2. Percentage of total body surface area affected

    Time frame: 4 weeks

    Percentage

  3. Absence of related adverse events (ADR)

    Time frame: 4 weeks

    Proportion of patients with no ADRs

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2016
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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