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22 May 2012
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| [ Print-friendly version ] |
| Randomised, double-blind, placebo-controlled trial of azathioprine in moderate to severe atopic eczema |
| ISRCTN | ISRCTN58943280 |
| ClinicalTrials.gov identifier | |
| Public title | Randomised, double-blind, placebo-controlled trial of azathioprine in moderate to severe atopic eczema |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | Azathioprine is a safe and effective treatment for moderate-to-severe atopic eczema. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Moderate-to-severe atopic eczema which is only partially controlled by standard therapy with topical steroids and emollients |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/02/2001 |
| Anticipated end date | 01/09/2002 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 62 |
| 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 our previously published dose regime. |
| Primary outcome measure(s) | Change in disease activity (SASSAD score over 12 weeks). |
| Secondary outcome measure(s) |
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) |
| Sources of funding |
This study was funded by:
1. British Skin Foundation (UK) - grant (Project number 226) 2. Wellcome Trust (UK) - indirectly via a Wellcome Research Leave Fellowship awarded to Nick Reynolds |
| Trial website | |
| Publications |
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16530578
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=11488818 |
| Contact name | Dr Simon Meggitt |
| Address |
Royal Victoria Infirmary
Queen Victoria Road |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE1 4LP |
| Country | United Kingdom |
| s.j.meggitt@ncl.ac.uk | |
| Sponsor | The Newcastle upon Tyne Hospitals NHS Trust (UK) |
| Address |
Royal Victoria Infirmary
Queen Victoria Road |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE1 4LP |
| Country | United Kingdom |
| jane.varey@nuth.nhs.uk | |
| Sponsor website: | http://www.newcastle-hospitals.org.uk/ |
| Date applied | 02/09/2005 |
| Last edited | 24/06/2008 |
| Date ISRCTN assigned | 04/11/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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