ltraviolet related deoxyribonucleic acid damage in skin of patients with atopic dermatitis and atopic status in relation to the use of Myfortic®

Completed

• Conditions: Atopic dermatitis; Skin and Connective Tissue Diseases; Skin condition

• Registration Number: ISRCTN23778671
• Lead Sponsor: niversity Medical Center Utrecht (UMCU) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Age from 18 years
2. Atopic dermatitis according to the criteria of Hanifin and Rajka
3. Insufficient response to topical therapy alone
4. The physician estimates that treatment with oral immunosuppressive agents is indicated

Exclusion Criteria

1. Patients with any known hypersensitivity to mycofenolic acid or other components of the formulation
2. Oral immunosuppressive treatment in the last six weeks
3. Concomitant Ultraviolet (UV) therapy or UV therapy in the last two months
4. Contact with UV on the lesional skin for the last two months
5. Patients with thrombocytopenia (less than 75,000/mm^3), with an absolute neutrophil count less than 1,500/mm^3 and/or leukocytopenia (less than 2,500/mm^3) and/or haemoglobin less than 6.0 g/dl prior to enrolment
6. Patients who have received an investigational drug within two weeks prior to screening
7. Patients with a history of malignancy within the last five years
8. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
9. Patients with an immunologic disorder (like Rheumatoid Arthritis [RA], Systemic Lupus Erythematosus [SLE] or M. SjÖgren) or a pre-existent dermatologic disorder that worsens in combination with UV (like LE or photosensitive eczema)
10. Presence of clinically significant infection requiring continued therapy, severe diarrhoea or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference between the percentage in repair of Cyclobutane Pyrimidine Dimers (CPD's) before and after treatment with Myfortic® is the primary study outcome.

Secondary Outcome Measures

Name	Time	Method
1. The atopic state before and after treatment with Myfortic®. <br>2. The evaluation of the efficacy of initial high dosing with Myfortic® in order to induce rapid improvement of the disease.