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

Phase 3

Completed

• Conditions: atopic dermatitis; atopic eczema; 10040900; 10014982

• Registration Number: NL-OMON30341
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

- age from 18 years
- atopic dermatitis according to the criteria of Hanifin and Rajka
- insufficient respons to topical therapy alone
- the physician estimates that treatment with oral immunosuppressiva agents is indicated.

Exclusion Criteria

- patients with any known hypersensitivity to mycofenolic acid or other components of the formulation.
- oral immunosuppressive treatment in the last 6 weeks.
- concomittant UV therapy or UV therapy in the last two months.
- contact with UV on the laesional skin for the last two months.
- patients with thrombocytopenia (<75.000/mm3), with an absolute neutrophil count <1.500/mm3 and/or leukocytopenia (<2.500/mm3) and/or hemoglobin <6,0g/dl priot to enrollment.
- patients who have received an investigational drug within two weeks prior to screening
- patients with a history of malignancy within the last five years.
- 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.
- Patients with an immunologic disorder (like RA, SLE or M. Sjögren) or a preexistent dermatologic disorder that worsens in combination with UV (like LE or photosensitive eczema).
- Presence of clinically significant infection requiring continued therapy, severe diarrhea or uncontrolled diabetes mellitus that would interfere with the appropiate conduct of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference between the percentage in repair of cyclobutane pyrimidine<br /><br>dimers (CPD's) before and after treatment with Myfortic is the primary study<br /><br>outcome.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary study outcome is the atopic state before, during and after<br /><br>treatment with Myfortic</p><br>