Randomised, double-blind, placebo-controlled trial of azathioprine in moderate to severe atopic eczema
| ISRCTN | ISRCTN58943280 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58943280 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/09/2005
- Registration date
- 04/11/2005
- Last edited
- 03/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simon Meggitt
Scientific
Scientific
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
| s.j.meggitt@ncl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Randomised, double-blind, placebo-controlled trial of azathioprine in moderate to severe atopic eczema |
| Study objectives | Azathioprine is a safe and effective treatment for moderate-to-severe atopic eczema. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Moderate-to-severe atopic eczema which is only partially controlled by standard therapy with topical steroids and emollients |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Azathioprine |
| Primary outcome measure | Change in disease activity (SASSAD score over 12 weeks). |
| Secondary outcome measures | 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) |
| Overall study start date | 01/02/2001 |
| Completion date | 01/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 62 |
| Key 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 Rajkas diagnostic criteria 3. Biochemistry (urea and electrolytes, Liver Function Tests [LFTs]) and Full Blood Count (FBC) are within the laboratorys 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 |
| Key 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) |
| Date of first enrolment | 01/02/2001 |
| Date of final enrolment | 01/09/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
NE1 4LP
United Kingdom
Sponsor information
The Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| jane.varey@nuth.nhs.uk | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
British Skin Foundation (UK) - grant (Project number 226)
No information available
Wellcome Trust (UK) - indirectly via a Wellcome Research Leave Fellowship awarded to Nick Reynolds
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | review of evidence | 01/07/2001 | Yes | No | |
| Results article | results | 11/03/2006 | Yes | No |
Editorial Notes
03/10/2017: internal review.
