Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. (TocyDD)
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|ClinicalTrials.gov Identifier: NCT01231854|
Recruitment Status : Terminated (delayed start of the trial, both treatment options already have market authorizations, study medication expired)
First Posted : November 1, 2010
Last Update Posted : June 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Ciclosporin Drug: Alitretinoin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. A Randomized Controlled Investigator-initiated Double-blind Trial.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2013|
|Active Comparator: Ciclosporingroup||
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).
Other Name: Immunosporin
|Active Comparator: Alitretinoingroup||
In accordance with the current guideline management of hand eczema alitretinoin will be administered orally in a constant daily dosage of 30 mg.
Other Name: Toctino
- Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.
- Time to complete or almost complete clearance according to IGA in both groups
- Proportion of patients with complete or almost complete clearance according to the Patients Global Assessment (PGA) within 12 weeks and 24 weeks of active therapy
- Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups
- Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups
- Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D)
- Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups
- Mean utilization of topical steroids within the follow-up period in both groups
- Patient satisfaction with treatment in both groups (assessed using a 100mm VAS Scale)
- Proportion of patients with relapse (≥ 75% of baseline HECSI) within 24-week follow-up after previous complete/almost complete clearance
- In patients with atopic dermatitis on the body: measured percentage of patients with at least 50% improvement in disease severity with the active therapy using the SCORAD.
- Tolerability and safety in both study groups
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): NCT01231854
|Universitätsklinikum Carl Gustav Carus an der TU Dresden|
|Dresden, Sachsen, Germany, 01307|