An Observational Study Investigating the Treatment Satisfaction of Atopic Dermatitis Patients Who Have Switched to Ointment (W/O Emulsion) Formulation of Very Strong Class Topical Corticosteroids (Ointment TS-AD)

LEO Pharma

Status: Completed

Conditions: Dermatitis, Atopic

Treatments: Drug: Diflucortolone valerate (Nerisona); Drug: Diflucortolone valerate (Texmeten)

Study type: Observational

Funder types: Industry

Identifiers

NCT02627989

18690

Details and patient eligibility

About

This study intends to investigate patient satisfaction of treatment with Ointment (W/O emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction, treatment adherence, itchiness, and AD severity scores.

Enrollment: 55 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male patients with a diagnosis of atopic dermatitis who are treated with Fatty Ointment Potency Class II (Very strong class) TCs
• Patients who are scheduled to change the formulation of the Potency Class II TC from Fatty Ointment to Ointment (Water in Oil; Water per Oil emulsion) as per investigator's routine treatment practice
• Patients who are aged over 20
• Patients who are able to understand and sign a written informed consent

Exclusion criteria

-Patients participating in an investigational program with interventions outside of routine clinical practice

• Patients with any contraindication to TCs
• Patients who are regarded as ineligible by the investigator
• Patients who are pregnant or breastfeeding
• For Period 2 (Spring-Summer), patients enrolled in the Period 1

Trial design

55 participants in 1 patient group

Diflucortolone valerate (Nerisona/Texmeten)

Description:

Adult patients with atopic dermatitis switching from diflucortolone-valerate fatty ointment to ointment (water/oil emulsion) during autumn/ winter (Nov to Feb) or spring/ summer (May to Aug)

Treatment:

Drug: Diflucortolone valerate (Nerisona)

Drug: Diflucortolone valerate (Texmeten)