Moderate to Severe Atopic Eczema Clinical Trial
Official title:
Narrowband Ultraviolet B Phototherapy in Children With Moderate to Severe Atopic Eczema- an Observational Prospective Controlled Study
To assess prospectively, the response of moderate to severe atopic eczema to a standard course of narrowband ultraviolet B phototherapy by using validated objective and subjective scoring systems.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | August 2010 |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years to 16 Years |
| Eligibility |
Inclusion Criteria: - Children aged 3-16 years with moderate to severe atopic eczema (as defined by the modified Hannifin and Rajka criteria) in whom there is a clinical indication for phototherapy (as deemed by their specialist Dermatology consultant). Exclusion Criteria: - Children under the age of 3 years or any child who lacks the maturity needed to stand in the phototherapy cabinet unsupervised. - Mild disease (defined as a Six Area Six Sign Atopic Dermatitis (SASSAD) score <10) |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Royal Victoria Infirmary | Newcastle-upon-Tyne |
| Lead Sponsor | Collaborator |
|---|---|
| Royal Victoria Infirmary | British Skin Foundation |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Score at the end of treatment compared to the control group | Measurement of Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected of those treated with narrowband UVB as compared to a control group | 12 weeks | No |
| Secondary | Subjective scores at the end of treatment as compared to controls | Subjective scoring using Patient Outcome Eczema Measure (POEM), Children's Dermatology Life Quality Index (CDLQI), Dermatitis Family Impact Questionnaire (DFI), Visual analogue scale (VAS) for itch and sleep loss | 12 weeks | No |
| Secondary | objective scores at 3 months post treatment compared to controls | Objective Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected in the treated group at 3 months post treatment as compared to controls. | 3 months | No |
| Secondary | Association of filaggrin status with outcome | To determine if response to phototherapy is determined by the presence of a homozygous or compound heterozygous filaggrin mutation. | 12 weeks | No |
| Secondary | Subjective scores at 3 months post treatment compared to controls | Subjective scores (Patient Outcome Eczema Measure (POEM),Children's Dermatology Life Quality Index (CDLQI), Dermatitis Family Impact Questionnaire (DFI), Visual Analogue Scale (VAS) for itch and sleep loss) in the treated group at 3 months post treatment as compared to controls. | 3 months | No |
| Secondary | Subjective scores at 6 months post treatment compared to controls | Subjective scores (Patient Outcome Eczema Measure (POEM),Children's Dermatology Life Quality Index (CDLQI), Dermatitis Family Impact Questionnaire (DFI), Visual Analogue Scale (VAS) for itch and sleep loss) in the treated group at 6 months post treatment as compared to controls. | 6 months | No |
| Secondary | Objective scores at 6 months post treatment compared to controls | Objective Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected in the treated group at 6 months post treatment as compared to controls. | 6 months | No |