Efficacy and Tolerability of Enstilar® in Daily Practice

Sponsor

LEO Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT02881346

Collaborator

(none)

410

Enrollment

Location

5.9

Actual Duration (Months)

68.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Plaque Psoriasis	Drug: Enstilar®

Study Design

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 :

Sep 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	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 Names: calcipotriol/betamethasone dipropionate cutaneous foam

Arm

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 Names:

calcipotriol/betamethasone dipropionate cutaneous foam

Outcome Measures

Primary Outcome Measures

Investigator Global Assessment [Week 4]
5-point Likert scale
Percentage of total body surface area affected [4 weeks]
Percentage
Absence of related adverse events (ADR) [4 weeks]
Proportion of patients with no ADRs

Secondary Outcome Measures

Patient Global Assessment [4 weeks]
5-point Likert scale
PASI 50 [4 weeks]
Psoriasis Area and Severity Index
PASI 75 [4 weeks]
Psoriasis Area and Severity Index
Patient reported itching [4 weeks]
10-point scale
Patient reported sleep loss [4 weeks]
10-point scale
Patient reported erythema [4 weeks]
10-point scale
Patient reported scaling [4 weeks]
10-point scale
Patient reported dry skin [4 weeks]
10-point scale
Patient reported overall treatment satisfaction [4 weeks]
4-point Likert scale
Patient reported satisfaction with effectiveness [4 weeks]
4-point Likert scale
Patient reported satisfaction with tolerability [4 weeks]
4-point Likert scale
Patient reported satisfaction with convenience [4 weeks]
4-point Likert scale
Dermatology Life Quality Index [4 weeks]
Standard Quality of Life Questionnaire (DLQI)