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
Randomised, double-blind, placebo-controlled trial of azathioprine in moderate to severe atopic eczema
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
Hospitals
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 Applicable
Drug names
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 trial start date
01/02/2001
Overall trial end date
01/09/2002
Reason abandoned (if study stopped)
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 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
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
Funders
Funder type
Charity
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
Basic results (scientific)
Publication list
1. 2001 review of evidence in https://www.ncbi.nlm.nih.gov/pubmed/11488818
2. 2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16530578
Publication citations
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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.
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Meggitt SJ, Reynolds NJ, Azathioprine for atopic dermatitis., Clin. Exp. Dermatol., 2001, 26, 5, 369-375.