The primary aim is to study the effect of treatment of severe AD patients with Myfortic on DNA-repair after irradiation with UVB.A secondary aim is to study the effect of treatment of severe AD patients on atopic status, measured as total IgE and…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
The secundary study outcome is the atopic state before, during and after
treatment with Myfortic
Background summary
Atopic dermatitis (AD) is a chronic inflammatory disease, presenting with
exacerbations and remissions, leading to an impaired quality of life in a large
group of patients. Continuously there is being searched for new and improved
treatments. Myfortic (mycofenolic acid) is a promising immunosuppressive drug
for the treatment of severe AD patients, especially those patients with an
atopic disposition.
- In literature a possible relationship between the use of oral
immunosuppressive drugs and the development of non-melanoma skin cancer is
suggested. There have been no in-vivo studies performed that evaluate the
effect of oral immunosuppressive drugs on UV-related DNA-damage.
- No in-vitro or in-vivo data exist on the effect of Myfortic on DNA-repair
after UV irradiation.
Study objective
The primary aim is to study the effect of treatment of severe AD patients with
Myfortic on DNA-repair after irradiation with UVB.
A secondary aim is to study the effect of treatment of severe AD patients on
atopic status, measured as total IgE and specific IgE, skin prick test and
atopy patch test.
Study design
10 patients in total with atopic dermatitis are to be included in the study.
The inclusion takes place after the physician has indicated that treatment with
oral immunosuppressive drugs is necessary. The informed consent intake will be
performed by the researcher. At inclusion a screening will be done to evaluate
the severity of the eczema and the atopic state (total and specific IgE,
skinpricktest and atopy patch test) of the patient.
Subsequently we will compare UV-irradiated, non-laesional skin prior to
treatment to UV-irradiated, non-laesional skin treated with Myfortic during 12
weeks. The Minimal Erythema Dose (MED) will be determined prior to actual
irradiation. Punch biopsies will be taken immediately after irradiation with 2
MED and after 24 hours. A reference biopsie will be taken from skin that is not
irrradiated. The whole proces will be repeated after 12 weeks of treatment.
To evaluate the atopic status after 12 weeks of treatment, we will repeat the
skinpricktest and atopy patch test. The final clinical evaluation of therapy
will be performed after 16 weeks.
Intervention
As mentioned in study design.
Study burden and risks
UV-irradiation can cause some skin irritation. If necessary the skin can be
treated with a mild corticosteroid ointment. There is a possibility that the
biopted skin shows some hypopigmentation in comparison to the surrounding skin.
During the trial 6 times a blood control will be performed with a maximum of 5
ml blood extra each time to evaluate the atopic status in the blood. Normally
there is also blood control each control visit (+/- 10 ml each time) to exlude
side effect of the treatment with mycofenolic acid. Furthermore twice a
skinpricktest and a atopy patch test will be performed to evaluate the atopic
status during Myforic treatment. We assess the severity of the eczema at each
visit by means of a clinical skin assessment score (SCORAD). Besides
above-mentioned there is no burden for the patient. The risks associated with
participation are minimal. The total time investment adds up to approximately
280 minutes (4,5 hours) divided over 12 visitis.
Heidelberglaan 100
3584 CX, Utrecht
NL
Heidelberglaan 100
3584 CX, Utrecht
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-004668-30-NL |
| CCMO | NL14196.041.06 |
| Other | NL14196.041.06 |