Trials Sponsors Conditions Drugs Pricing

Conditions

Adherence, Patient Chronic Eczema

Outcome Measures

Primary Outcomes (5)

Adherence to treatment
Adherence defined as percentage of patients applying at least aimed daily dose Adherence will be assumed, if * truly applicated daily dose is at least 75% of prescribed daily dose and * the individual mean number of applications per day is at least 0.85
28 days
Measurement 1
Hand surface \[cm²\]
28 days; visit 1 (day 1)
Measurement 2
Weight of topical drug container \[mg\]
28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)
Individual amount of topical drug
\- weight of topical drug container \[mg\] by hand surface \[cm²\] will be combined to individual amount of topical drug which will as well be the prescribed daily dose
28 days
Truly applicated daily dose
\- individual amount of topical drug used \[mg/cm²\] by individual mean number of applications
28 days

Secondary Outcomes (2)

Change of Hand Eczema
28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)
Change of Hand Eczema
28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)

Study Arms (2)

cream

ACTIVE COMPARATOR

Treatment with topical Methylprednisolone aceponate 0,1% cream (Advantan®) plus Basic care (Bepanthen® Sensiderm)

Behavioral: Adherence to topical standard therapy assessed

fatty ointment

ACTIVE COMPARATOR

Treatment with topical Methylprednisolone aceponate 0,1% fatty ointment (Advantan®) plus Basic care (Bepanthen® Sensiderm)

Behavioral: Adherence to topical standard therapy assessed

Interventions

Adherence to topical standard therapy assessedBehavioral

Adherence defined as percentage of patients applying at least aimed daily dose

creamfatty ointment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated informed consent has been obtained.
Clinical diagnosis of chronic mild-to-moderate hand dermatitis with or without atopic etiology or background (according to IGA: at least mild at Visit 1).

Sponsors & Collaborators

Jena University Hospital
Otherlead
Bayer
Industrycollaborator

Study Sites (1)

Jena University Hospital

Jena, Thuringia, 07743, Germany

Related Publications (9)

Diepgen TL, Andersen KE, Chosidow O, Coenraads PJ, Elsner P, English J, Fartasch M, Gimenez-Arnau A, Nixon R, Sasseville D, Agner T. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1-22. doi: 10.1111/ddg.12510_1.
PMID: 25763418BACKGROUND
Torrelo A. Methylprednisolone aceponate for atopic dermatitis. Int J Dermatol. 2017 Jun;56(6):691-697. doi: 10.1111/ijd.13485. Epub 2017 Mar 4.
PMID: 28258632BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

Peter Elsner, Prof. Dr. med.
University hospital Jena
PRINCIPAL INVESTIGATOR

Enrollment

80 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: CARE PROVIDER, INVESTIGATOR
Masking Details: The investigator of the study will not know in which vehicle the enrolled patient will receive the standard therapeutical drug
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Prof. Dr. med. P. Elsner, Head of Dermatology, Principal Investigator

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 11, 2019

Study Start

A Clinical Study of Adherence to Methylprednisolone Aceponate in Different Carriers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (2)

Study Arms (2)

cream

fatty ointment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (2)

Study Arms (2)

cream

fatty ointment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations