Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. (TocyDD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Technische Universität Dresden.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01231854
First received: October 29, 2010
Last updated: November 11, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: Ciclosporin
Drug: Alitretinoin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. A Randomized Controlled Investigator-initiated Double-blind Trial.

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to complete or almost complete clearance according to IGA in both groups [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups [ Designated as safety issue: No ]
  • Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups [ Designated as safety issue: No ]
  • Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D) [ Designated as safety issue: No ]
  • Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups [ Designated as safety issue: No ]
  • Mean utilization of topical steroids within the follow-up period in both groups [ Designated as safety issue: No ]
  • Patient satisfaction with treatment in both groups (assessed using a 100mm VAS Scale) [ Designated as safety issue: No ]
  • Proportion of patients with relaps (≥ 75% of baseline HECSI) within 24-week follow-up after previous complete/almost complete clearance [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • Tolerability and safety in both study groups [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: November 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ciclosporingroup 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).
Other Name: Immunosporin
Active Comparator: Alitretinoingroup 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.
Other Name: Toctino

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female Patients age > 18 years and ≤ 75 years
  • Body weight 50 to 100 kg
  • Chronic hand dermatitis (duration > 6 months)
  • Atopic constitution according to

    • Erlanger Atopiescore1 and/or
    • positive personal history for atopic eczema, allergic rhinitis, allergic asthma and/or
    • elevated serum IgE
  • Severe hand dermatitis not responding to treatment with potent topical steroids for at least 4 weeks within the past 6 months due to IGA
  • Written informed consent

Exclusion Criteria:

  • Participation in other clinical trial within past 4 weeks
  • Pregnancy/breastfeeding
  • Women within reproductive age except those women who fulfil at least one of the following criteria throughout the total study and until at least 5 weeks after active study treatment in case of early study termination:
  • post-menopausal women (12 months physiological amenorrhoea or 6 months amenorrhoea with serum FSH level > 40 mlU/ml),
  • postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
  • Regular and proper use of at least two methods of contraception, including at least one method of contraception with a failure rate <1% per year (eg, implants, depot preparations, oral contraceptives, IUD).
  • vasectomy of the partner.
  • Women within reproductive age, who do not meet all of the following criteria throughout the whole study or - in case of early study termination - up to 5 weeks after active therapy:
  • The patient understands the teratogenic risk associated with taking the study medication.
  • The patient understands the need for strict monthly monitoring, the need for a reliable, continuous contraception and the need for regular pregnancy tests throughout the study and - in case of early study termination - up to 5 weeks of active therapy.
  • The patient is able to adequately and reliably apply methods of contraception.
  • The patient is informed about the possible consequences of pregnancy and knows that she must immediately contact her physician in case of suspected pregnancy.
  • The patient gives informed consent about knowing the potential risks and necessary measures to avoid pregnancy.
  • Blood and/or plasma donation during the whole study period. In case of early study termination blood and plasma donation is not allowed until 1 month after the end of active study treatment
  • UV-therapy within past 3 months
  • Concurrent photo-and / or photochemotherapy
  • Known Hypersensitivity / Intolerance against ciclosporin, alitretinoin or any other ingredients of Immunosporin® or Toctino®
  • Known Allergy against peanuts or soya
  • Known Hereditary fructose intolerance
  • Acute and/or uncontrolled chronic infectious disease
  • Known Congenital or acquired immune deficiency
  • Malignant tumor (past or present)
  • Uncontrolled arterial hypertension (RR systolic ≥ 160 mm Hg and/or RR diastolic≥ 90 mm Hg despite anti-hypertensive treatment)
  • Renal insufficiency (Serum creatinine above normal range)
  • Liver insufficiency (CHILD ≥ Stadium B)
  • Not sufficiently controlled hyperlipidemia (LDL/HDL ratio > 4 despite medical treatment)
  • Clinically significant thyroid hypofunction
  • Known Hypervitaminosis A
  • Concurrent supplementation of vitamin A or treatment with other retinoids
  • Concurrent tetracycline therapy
  • Concurrent therapy with St. John's wort ("Johanniskraut")
  • Known genetic diseases causing increased UV light sensitivity such as Xeroderma pigmentosum, Cockayne-syndrome, Bloom syndrome
  • Known Drug- and/or alcohol abuse
  • Known significant psychiatric morbidity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231854

Contacts
Contact: Jochen Schmitt, MD + 49 351 458 4083 jochen.schmitt@uniklinikum-dresden.de

Locations
Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden Not yet recruiting
Dresden, Sachsen, Germany, 01307
Contact: Jochen Schmitt, MD    +49 351 458 4083    jochen.Schmitt@uniklinikum-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden
  More Information

No publications provided

Responsible Party: Jochen Schmitt, Universitätsklinikum Carl Gustav Carus an der TU Dresden
ClinicalTrials.gov Identifier: NCT01231854     History of Changes
Other Study ID Numbers: TUD-TOCYDD-044, 2009-017520-88
Study First Received: October 29, 2010
Last Updated: November 11, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
atopic hand dermatitis
Chronic hand dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyclosporins
Cyclosporine
Tretinoin
Alitretinoin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antineoplastic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on April 23, 2014