Moderate-to-severe atopic eczema which is only partially controlled by standard therapy with topical steroids and emollients Skin and Connective Tissue Diseases Eczema
Conditions
Interventions
Adjunctive treatment with either azathioprine or placebo suspension in patients on optimal topical therapy. Patients and investigators are blinded to treatment allocation. Azathioprine dosing as per o
Sponsors
The Newcastle upon Tyne Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged from 16 to 65 years inclusive 2. The diagnosis of atopic eczema will be based on the UK modification of Hanifin and Rajka?s diagnostic criteria 3. Biochemistry (urea and electrolytes, Liver Function Tests [LFTs]) and Full Blood Count (FBC) are within the laboratory?s reference ranges. If not, the subject can be included only on condition that the investigator judges that deviations are not clinically relevant 4. All patients will provide written informed consent to participate
Exclusion criteria
Exclusion criteria: Patients will be ineligible for entry in the study if any of the following apply: 1. Very low/undetectable Thiopurine Methyltransferase (TPMT) activity (less than 2.5 nmol/h/ml Red Blood Cells [RBC]) 2. Transfusion prior to TPMT assessment 3. Concomitant unstable or serious systemic disease, including subjects known to be Human Immunodeficiency Virus (HIV) positive 4. Previous malignant disease, or serious hepatic, renal or haematological disease 5. Current heavy alcohol abuse or class A illicit drug abuse 6. The patient has had any major surgical procedure within four weeks of the intended entry date into the trial 7. Women who are pregnant or lactating 8. Prominent infected eczema or eczema requiring systemic antibacterial treatment during the two weeks prior to trial entry 9. Use of very potent topical steroids during the two weeks prior to entry (e.g. 0.05% Clobetasol propionate [Dermovate]) 10. Treatment with any of the following in the three months prior to commencing the trial: a. Systemic steroids b. Cyclosporin A c. Mycophenolate mofetil d. Topical tacrolimus e. Hospital phototherapy or sunbeds f. Chinese herbal medicine g. Evening primrose oil h. Hospital admission for the management of eczema 11. Concurrent drugs which could interact with azathioprine metabolism (rifampicin and allopurinol) 12. Mild eczema (disease activity score: Six Area Six Sign Atopic Dermatitis [SASSAD] less than 10)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in disease activity (SASSAD score over 12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global response assessed by patient and investigator 2. Patient assessed itch and loss of sleep 3. Body surface area affected 4. Weight of topical steroid used 5. Soluble CD30 levels 6. Quality of life (dermatology quality of life index) | — |
Countries
United Kingdom
Outcome results
None listed