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Trial registered on ANZCTR


Trial ID
ACTRN12613000604707
Ethics application status
Not yet submitted
Date submitted
24/05/2013
Date registered
28/05/2013
Date last updated
28/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Psoriasis and Geothermal Water
Scientific title
Investigation to measure and evaluate the effects of a geothermal water on Psoriasis
Secondary ID [1] 282571 0
Nil
Universal Trial Number (UTN)
U1111-1139-9531
Trial acronym
PGW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 289247 0
Condition category
Condition code
Skin 289574 289574 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bathing in a natural geothermal water : eight twenty minute baths every 2 -3 days over 20 days. An excel speadsheet lists the schedule for each participant , when attendance is due, non attendance, contact deatils etc . A folder contains a section for each partricipant including, consent, baseline recordings, questionnaire and PASI forms to be written on at each treatment and at two followup visits with no treatment. Questionaire and vital signs at the final visit. Wash Out period 14 days
Intervention code [1] 287232 0
Treatment: Other
Comparator / control treatment
Bathing in mains water in the same schedule at QE Health
Control group
Placebo

Outcomes
Primary outcome [1] 289665 0
The Effect of a geothermal water on Psoriasis rash by PASI scoring and verbal comment to open question; "How has the rash been since your last bathing treatment?" Photographs and Psoriasis self assessment Questionnaire at Baseline and 14 days post intervention.
Timepoint [1] 289665 0
after 20 days of bathing plus 14 days final assessment = at 34 days
after crossover 34 days = at 68 days after
Compare with Baseline
Secondary outcome [1] 302977 0
General Wellness. Vital signs: Temperature, pulse, blood pressure, respirations, weight at baseline and 14 days post intervention
Timepoint [1] 302977 0
after 20 days of bathing plus 14 days final assessment = at 34 days
after crossover 34 days = at 68 days after
Compare with Baseline

Eligibility
Key inclusion criteria
Documented proof of diagnosis of Psoriasis, and have active psoriatic skin condition
Able to access bath used for treatment, able to attend treatments as scheduled and understands the study procedures and risks involved, and voluntarily agrees to participate by giving written informed consent
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently participating, or has participated, in a research study when treatment occurred within the last 3 months
Has skin condition other than psoriasis
Has broken skin (open cracks in psoriatic lesions are not an exclusion).
Has a significant medical condition or history which may interfere with full participation in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation in choosing whether participant will have geothermal water or placebo. The participant will pick a number which has been randomly allocated intervention or placebo
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a computer generated randomisation list.


Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
two arm,aiming for superiority
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The aim of the test will be to test if on average a 50% reduction in PASI score is achieved across all patients enrolled in the trial between baseline and final measurement. Carlin et al (J Am Acad Dermatol. 2004 Jun;50(6):859-66) found that a 50% reduction in PASI score represents a clinically meaningful reduction in disease and should be the benchmark for future treatment tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5104 0
New Zealand
State/province [1] 5104 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 287348 0
Other
Name [1] 287348 0
QE Hospital Ltd trading as QE Health.
Address [1] 287348 0
1073 Whakaue St
Rotorua 3010
Country [1] 287348 0
New Zealand
Primary sponsor type
Other
Name
QE Health
Address
PO Box 1342
Rotorua 3040
Country
New Zealand
Secondary sponsor category [1] 286095 0
None
Name [1] 286095 0
Address [1] 286095 0
Country [1] 286095 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289333 0
HDEC
Ethics committee address [1] 289333 0
Northern A Health and Disability Ethics Committee
Novotel Ellerslie
72-112 Greenlane Rd East,
Auckland 1050
Ethics committee country [1] 289333 0
New Zealand
Date submitted for ethics approval [1] 289333 0
30/05/2013
Approval date [1] 289333 0
Ethics approval number [1] 289333 0

Summary
Brief summary
Will bathing in a geothermal water reduce skin rashes due to psoriasis? People will be recruited who still have psoriatic skin rash despite other treatments. Participants will be randomly selected to receive either the intervention schedule or the control schedule first. The intervention and the control schedules are to bathe at QE Health at intervals over 20 days and we assess the rash at each visit using PASI scoring for size, redness and scaling and ask how the rash has been. Assessments include PASI scoring. Plus a questionnaire, photographs of the rash and vital signs are recorded at the first and last visits of each schedule.
Participants crossover and do both schedules one after the other
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40318 0
Mr Peter Sharplin
Address 40318 0
QE Health
1073 Whakaue St
PO Box 1342
Rotorua 3040
Country 40318 0
New Zealand
Phone 40318 0
64 7 348 0189
Fax 40318 0
Email 40318 0
peter.sharplin@qehealth.co.nz
Contact person for public queries
Name 40319 0
Ms Prudence Paterson
Address 40319 0
QE Health
1073 Whakaue St
PO Box 1342
Rotorua 3040
Country 40319 0
New Zealand
Phone 40319 0
64 7 348 0189
Fax 40319 0
Email 40319 0
prue.paterson@qehealth.co.nz
Contact person for scientific queries
Name 40320 0
Mr Peter Sharplin
Address 40320 0
QE Health
1073 Whakaue St
PO Box 1342
Rotorua 3040
Country 40320 0
New Zealand
Phone 40320 0
64 7 348 0189
Fax 40320 0
Email 40320 0
peter.sharplin@qehealth.co.nz