Ultraviolet Light (UV) Therapy for Atopic Dermatitis: Double blind, randomised trial of narrow band (TLO1) versus UVA versus placebo.
| ISRCTN | ISRCTN10725589 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10725589 |
| Protocol serial number | 94090017 R140/05081 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 15/12/2009
- 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 Nicholas Reynolds
Scientific
Scientific
Department of Dermatology
Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 222 8936 |
|---|---|
| n.j.reynolds@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | There is a need for safe alternative therapies to emollients and topical steroids in atopic dermatitis. Recent non-blinded studies suggest that ultraviolet A (UVA) and narrow band width UVB (TLO1) phototherapy may be effective in atopic dermatitis. We propose to study 75 adult patients, age 16-65 years with moderate severe atopic dermatitis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Skin and connective tissue diseases: |
| Intervention | 1. TLO1-UVB 2. UVA 3. Placebo phototherapy Initial dose of UVA will be 5 J/sq cm, increased to 10 then 15 J/sq cm as tolerated. Initial dose of TLO1 will be increased from 0.4, to 0.6, to 0.9, to 1.2 J/sq cm until mild erythema develops and then according to a defined protocol. Visible fluorescent lamps will be employed for placebo treatments. Treatments will be twice weekly for a maximum of 24 exposures. |
| Intervention type | Other |
| Primary outcome measure(s) | Preliminary work suggests a response should be detectable after 12 treatments. Physical signs of disease activity, overall extent of disease, patient symptoms and quantities of topical steroids used will be assessed, by an observer who is unaware of treatment received, at baseline, after 6, 12, 18 and 24 treatments and 3 months after stopping phototherapy. |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 30/06/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 75 |
| Key inclusion criteria | Patients, aged 16-65 years with moderate severe atopic dermatitis. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/06/1996 |
| Date of final enrolment | 30/06/1998 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Dermatology
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/06/2001 | Yes | No |
