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Efficacy and Tolerability of Enstilar® in Daily Practice

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ClinicalTrials.gov Identifier: NCT02881346
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : August 4, 2017
Sponsor:
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®

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


Group/Cohort Intervention/treatment
Enstilar®
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 ]
    Percentage

  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)



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02881346


Locations
Germany
Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein
Kiel, Germany
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Sascha Gerdes, Dr.med. Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein, Campus Kiel

Publications of Results:
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02881346     History of Changes
Other Study ID Numbers: NIS-ENSTILAR-1295
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by LEO Pharma:
Psoriasis vulgaris
Plaque
Topical
Calcipotriol
Foam
Spray

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents