Condition category
Skin and Connective Tissue Diseases
Date applied
02/09/2005
Date assigned
04/11/2005
Last edited
24/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Meggitt

ORCID ID

Contact details

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
s.j.meggitt@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Azathioprine is a safe and effective treatment for moderate-to-severe atopic eczema.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Azathioprine

Primary outcome measures

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 trial start date

01/02/2001

Overall trial end date

01/09/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

62

Participant 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)

Recruitment start date

01/02/2001

Recruitment end date

01/09/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

The Newcastle upon Tyne Hospitals NHS Trust (UK)

Sponsor details

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
jane.varey@nuth.nhs.uk

Sponsor type

Government

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

This study was funded by:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

British Skin Foundation (UK) - grant (Project number 226)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Wellcome Trust (UK) - indirectly via a Wellcome Research Leave Fellowship awarded to Nick Reynolds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Meggitt SJ, Gray JC, Reynolds NJ, Azathioprine dosed by thiopurine methyltransferase activity for moderate-to-severe atopic eczema: a double-blind, randomised controlled trial., Lancet, 2006, 367, 9513, 839-846, doi: 10.1016/S0140-6736(06)68340-2.

  2. Meggitt SJ, Reynolds NJ, Azathioprine for atopic dermatitis., Clin. Exp. Dermatol., 2001, 26, 5, 369-375.

Additional files

Editorial Notes