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Trial registered on ANZCTR
Registration number
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
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Scientific title
Investigation to measure and evaluate the effects of a geothermal water on Psoriasis
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Secondary ID [1]
282571
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Nil
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Universal Trial Number (UTN)
U1111-1139-9531
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Trial acronym
PGW
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
289247
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Condition category
Condition code
Skin
289574
289574
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
287232
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Treatment: Other
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Comparator / control treatment
Bathing in mains water in the same schedule at QE Health
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
289665
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Timepoint [1]
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after 20 days of bathing plus 14 days final assessment = at 34 days
after crossover 34 days = at 68 days after
Compare with Baseline
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Secondary outcome [1]
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General Wellness. Vital signs: Temperature, pulse, blood pressure, respirations, weight at baseline and 14 days post intervention
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Assessment method [1]
302977
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Timepoint [1]
302977
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after 20 days of bathing plus 14 days final assessment = at 34 days
after crossover 34 days = at 68 days after
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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
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a computer generated randomisation list.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
two arm,aiming for superiority
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/07/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
33
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5104
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New Zealand
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State/province [1]
5104
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Bay of Plenty
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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QE Hospital Ltd trading as QE Health.
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Address [1]
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1073 Whakaue St
Rotorua 3010
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Country [1]
287348
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New Zealand
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Primary sponsor type
Other
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Name
QE Health
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Address
PO Box 1342
Rotorua 3040
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Country
New Zealand
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Secondary sponsor category [1]
286095
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None
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Name [1]
286095
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Address [1]
286095
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Country [1]
286095
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
289333
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HDEC
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Ethics committee address [1]
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Northern A Health and Disability Ethics Committee
Novotel Ellerslie
72-112 Greenlane Rd East,
Auckland 1050
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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30/05/2013
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Approval date [1]
289333
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Ethics approval number [1]
289333
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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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Peter Sharplin
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Address
40318
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QE Health
1073 Whakaue St
PO Box 1342
Rotorua 3040
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Country
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New Zealand
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Phone
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64 7 348 0189
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Fax
40318
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Prudence Paterson
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Address
40319
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QE Health
1073 Whakaue St
PO Box 1342
Rotorua 3040
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Country
40319
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New Zealand
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Phone
40319
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64 7 348 0189
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Fax
40319
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Email
40319
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[email protected]
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Contact person for scientific queries
Name
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Mr Peter Sharplin
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Address
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QE Health
1073 Whakaue St
PO Box 1342
Rotorua 3040
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Country
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New Zealand
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Phone
40320
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64 7 348 0189
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Fax
40320
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Email
40320
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[email protected]
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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
No additional documents have been identified.
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