MedTrace Logo

Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.

NCT01231854 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-06-03

No results posted yet for this study

Summary

The purpose of this study is to investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.

Conditions

Interventions

DRUG

Ciclosporin

In accordance with the current guideline concerning the use of ciclosporin in dermatology and the current guideline management of hand eczema the daily oral dosage of ciclosporin microemulsion is 2.7 to 4.0 mg/kg bodyweight (half of the total daily dosage will be administered in the morning and in the evening). To enable both body-weight adjusted treatment and double-blind treatment patients will be allocated to 2 different dosages depending on their body weight (50-74.9 kg: daily dosage 200 mg; 75-100 kg: daily dosage 300 mg).

DRUG

Alitretinoin

In accordance with the current guideline management of hand eczema alitretinoin will be administered orally in a constant daily dosage of 30 mg.

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-03-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01231854 on ClinicalTrials.gov