Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.

NCT01231854 | Terminated Phase 4

• 2 other identifiers: TUD-TOCYDD-0442009-017520-88
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

atopic hand dermatitis; Chronic hand dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 (11)

• 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)

Study Arms (2)

Ciclosporingroup

ACTIVE COMPARATOR

Drug: Ciclosporin

Alitretinoingroup

ACTIVE COMPARATOR

Drug: Alitretinoin

Interventions

Ciclosporin DRUG

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).

Also known as: Immunosporin

Ciclosporingroup

Alitretinoin DRUG

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

Also known as: Toctino

Alitretinoingroup

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Cyclosporine; Alitretinoin

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Tretinoin; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 1, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2013
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

DE (1)