A randomised double-blinded cross-over trial comparing betamethasone valerate and tacrolimus ointment for the treatment of moderate to severe atopic eczema
| ISRCTN | ISRCTN27411543 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27411543 |
| Protocol serial number | N0263128762 |
| Sponsor | Department of Health |
| Funder | University College London Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 17/04/2015
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R C H Yu
Scientific
Scientific
Dermatology Department
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blinded cross-over trial |
| Secondary study design | Randomised cross over trial |
| Scientific title | A randomised double-blinded cross-over trial comparing betamethasone valerate and tacrolimus ointment for the treatment of moderate to severe atopic eczema |
| Study objectives | Is tacrolimus more efficacious than betamethasone valerate ointment in moderate to severe atopic dermatitis? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Skin and Connective Tissue Diseases: Atopic dermatitis |
| Intervention | 1. Steroid ointment 2. Other ointment |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Betamethasone valerate and tacrolimus ointment |
| Primary outcome measure(s) |
SCORAD score (numerical assessment score of patient symptoms, range 0-103). Ointment weight. Recording of side-effects noted. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 patients from Dermatology |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 31/01/2003 |
| Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Middlesex Hospital
London
W1N 8AA
United Kingdom
W1N 8AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
