Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001130954
Ethics application status
Not yet submitted
Date submitted
10/10/2011
Date registered
28/10/2011
Date last updated
28/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Narrow Band Ultraviolet B (UVB) Phototherapy on Vitamin D levels in patients with Psoriasis and Broad band Ultraviolet B and A used for dermatitis
Scientific title
Patients with Psoriais and Dermatitis The Effects of Ultraviolet B and A Phototherapy On Vitamin D levels
Secondary ID [1] 273188 0
Nil
Universal Trial Number (UTN)
U1111-1125-1431
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D levels 278937 0
Psoriasis 278938 0
Dermatitis 279019 0
Condition category
Condition code
Skin 279119 279119 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with psoriasis and severe dermatitis will attend 3 times weekly for a minimal of 6 and in many case 10 or more weeks. Each treatment is on average 5 minutes. There are no phototherapy cabinets in the hospital public system. Patients will enter phototherapy cabinets located at the Fremantle Dermatology Clinic. They all start on a low dose according to their skin type and are pushed up in dosage depending on their response to treatment. All that is different is we will be drawing pre and in treatment blood to measure Vitamin D levels.

The minimum dose for Phototherapy is 0.05 joules and the maximum dose is 1.20 joules for Narrowband UVB and UVA.

Pre-treatment and post treatment bloods will be 5ml each time. For Vitamin D Assay an amount of 1/2 - 1 SST tube needs to be taken (ie max 5mls).

All patients will have at least a minimal of 4-6 weeks of treatment at three times a week. This would be a minimum requirement to a Phototherapy patient to achieve some therapeutic response. In regards to those that achieve a very good response, we will be titrating their treatment. Those that require a longer response will continue on. It is suggested that we chase the Vitamin D at the 6 week margin automatically so that all patients will have standardised 3 times week treatment course for 6 weeks.
Intervention code [1] 269514 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279763 0
We propose to measure Vitamin D levels in patients pre and post UVB phototherapy through a blood test measuring serum levels of Vitamin D.
Timepoint [1] 279763 0
Vitamin D levels will be measured at the start of treatment (baseline, time 0) and then again at the completion of treatment (varying from 2 to 6 months).
Secondary outcome [1] 294390 0
Nil
Timepoint [1] 294390 0
NA

Eligibility
Key inclusion criteria
Patients with dermatological skin conditions (psoriasis, severe dermatitis) undergoing UVB or UVA phototherapy, not currently taking Vitamin D or calcium supplements.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients on Vitamin D / calcium supplements

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270008 0
Other
Name [1] 270008 0
Fremantle Dermatology
Country [1] 270008 0
Australia
Primary sponsor type
Individual
Name
Professor Kurt Gebauer
Address
High Street
Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 268988 0
None
Name [1] 268988 0
Address [1] 268988 0
Country [1] 268988 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271970 0
Fremantle Hospital Ethics Committee
Ethics committee address [1] 271970 0
Ethics committee country [1] 271970 0
Australia
Date submitted for ethics approval [1] 271970 0
30/10/2011
Approval date [1] 271970 0
Ethics approval number [1] 271970 0
NA

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33255 0
Address 33255 0
Country 33255 0
Phone 33255 0
Fax 33255 0
Email 33255 0
Contact person for public queries
Name 16502 0
Jenny Tu
Address 16502 0
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 16502 0
Australia
Phone 16502 0
+610893463333
Fax 16502 0
Email 16502 0
[email protected]
Contact person for scientific queries
Name 7430 0
Jenny Tu
Address 7430 0
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 7430 0
Australia
Phone 7430 0
+610893463333
Fax 7430 0
Email 7430 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSerum 25-hydroxyvitamin D increases with NB-UVB and UVA/UVB phototherapy in patients with psoriasis and atopic dermatitis in Western Australia.2016https://dx.doi.org/10.1111/ajd.12315
N.B. These documents automatically identified may not have been verified by the study sponsor.