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 |
| Secondary identifying numbers | N0263128762 |
- 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
| Study design | Randomised double-blinded cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Betamethasone valerate and tacrolimus ointment |
| Primary outcome measure | SCORAD score (numerical assessment score of patient symptoms, range 0-103). Ointment weight. Recording of side-effects noted. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 31/01/2003 |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
The Middlesex Hospital
London
W1N 8AA
United Kingdom
W1N 8AA
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
University College London Hospitals NHS Trust (UK)
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 |
