Clinical trial NCT01231854: Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.
Official title: Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. A Randomized Controlled Investigator-initiated Double-blind Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: atopic hand dermatitis
Chronic hand dermatitis
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.
Secondary outcomes:
measure: Time to complete or almost complete clearance according to IGA in both groups
measure: 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
measure: Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups
measure: Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups
measure: Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D)
measure: Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups
measure: Mean utilization of topical steroids within the follow-up period in both groups
measure: Patient satisfaction with treatment in both groups (assessed using a 100mm VAS Scale)
measure: Proportion of patients with relapse (≥ 75% of baseline HECSI) within 24-week follow-up after previous complete/almost complete clearance
measure: 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.
measure: Tolerability and safety in both study groups
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
state: Sachsen
Study officials:
References: