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Trial registered on ANZCTR
Registration number
ACTRN12620000546954
Ethics application status
Approved
Date submitted
18/03/2020
Date registered
7/05/2020
Date last updated
14/03/2023
Date data sharing statement initially provided
7/05/2020
Date results information initially provided
4/10/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparing the effect of Narrowband ultraviolet B (UVB) therapy to therapy with natural sunlight and an amino acid lecithin cream on dermatologic symptoms
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Scientific title
Comparing the effect of Narrowband ultraviolet B (UVB) therapy to therapy with natural sunlight and an amino acid lecithin cream on dermatologic symptoms in patients with dermatologic conditions
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Secondary ID [1]
300814
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Nil known
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Universal Trial Number (UTN)
U1111-1249-8985
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
316697
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Atopic dermatitis
316698
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Pruritus
316699
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Vitiligo
316700
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Condition category
Condition code
Skin
314941
314941
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0
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Exposure to a measured dose on natural sunlight utilising a UV-integrator/radiometer following application of an L-tryptophan/lecithin/polyvinyl alcohol cream by a trained dermatological nurse. This will occur three times weekly for a period of twelve weeks for psoriasis, atopic dermatitis and pruritus and six months for vitiligo. Application of the cream will occur at the Qld Institute of Dermatology. Sun exposure can occur in proximity to the Institute or at home if preferable.
The initial dose of sunlight is based on Fitzpatrick Skin type and varies between 400mJ for Fitzpatrick Skin type 1 to 1200mJ for Fitzpatrick Skin type 6. The incremental increase is 20% three times weekly with a capped dose of 20000mJ
The duration of each session is as long as it takes to reach the prescribed sunlight dose.
The duration of the exposure is dependent on the intensity of sun and will thus vary depending on the time of the day and season. Anticipated duration for an initial exposure would be 5 minutes increasing to 90-120 minutes for the maximum capped dose.
The cream is applied immediately prior to sun exposure to the involved area's for all conditions.
Interventional adherence is confirmed by logging the sunlight dose recorded on the radiometer
Trial participants that fail to respond to sunlight by the allotted time will receive a course of Narrowband ultraviolet B therapy (NBUVB). The allotted time is defined as 12 weeks for psoriasis, atopic dermatitis and pruritus and 24 weeks for vitiligo. All ongoing treatment will be via NBUVB.
For the participant this will involve attending the Qld Institute of Dermatology three times per week for a 12 week period for psoriasis, atopic dermatitis and pruritus or 24 weeks for vitiligo. The cream will be applied by nursing staff and the participant will be provided with an integrated radiometer. They can expose themselves to sunlight in the vicinity of QID or at home before returning the radiometer to QID following the prescribed dosage where the dose will be logged.
The dose of cream is 0.5G per hand sized area of skin ie as the recommended corticsteroid dose.
The dose concentration of the cream is
2% L tryptophan
30% Sunflower lecithin
3% Polyvinyl alcohol
20% ethanol
pH 5.8
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Intervention code [1]
317144
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Treatment: Other
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Comparator / control treatment
The control group will receive a standardised course of narrow band UVB suitable for their dermatological condition. This will be an initial dose of 50 milijoules increasing in 20% increments three times weekly. The time period will be 12 weeks for psoriasis, atopic dermatitis and pruritus and 24 weeks for vitiligo. The starting dose and percentage increment increases may be modified depending on tolerance and Fitzpatrick skin type.
This will be administered by a dermatological nurse at the Qld Institute of Dermatology
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Control group
Active
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Outcomes
Primary outcome [1]
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The proportion of patients with a meaningful clinical response defined as an improvement of 75% in the baseline PASI score for participants with psoriasis, EASI score for participants with atopic dermatitis, VASI score for participants with vitiligo or visual analogue scale for participants with pruritus
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Assessment method [1]
323255
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Timepoint [1]
323255
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12 weeks for psoriasis, atopic dermatitis and pruritus
6 months for vitiligo
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Primary outcome [2]
323300
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A skin biopsy from a light protected and light exposed area will also be taken for immuno-histochemical staining to ascertain cytochrome P450 induction
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Assessment method [2]
323300
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Timepoint [2]
323300
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12 weeks for psoriasis, atopic dermatitis and pruritus. 24 weeks for vitiligo
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Secondary outcome [1]
381320
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nil
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Assessment method [1]
381320
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Timepoint [1]
381320
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Not applicable
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Eligibility
Key inclusion criteria
Adult patients with psoriasis, atopic dermatitis, pruritus or vitiligo eligible for treatment with Narrowband UVB
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Minimum age
18
Years
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Maximum age
No limit
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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
Patients under the age of 18
Pregnant or lactating females
Patients with known sensitivity to the topical agents
Patients with cutaneous T or B cell lymphoma
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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)
Allocation concealed via central computer randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
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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
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Based on an alpha value of 0.05 and a power of 80%, an expected improvement of 75% in the NBUVB group and 70% in the heliotherapy group the sample size needs to be at least 32 with 16 in either group.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
14/04/2021
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Actual
14/04/2021
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Date of last participant enrolment
Anticipated
1/05/2022
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Actual
31/05/2022
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Date of last data collection
Anticipated
2/01/2023
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Actual
11/03/2023
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Sample size
Target
32
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
16140
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Queensland Institute of Dermatology - South Brisbane
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Recruitment postcode(s) [1]
29669
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4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
305270
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Self funded/Unfunded
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Name [1]
305270
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DR ROWLAND NOAKES
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Address [1]
305270
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QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
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Country [1]
305270
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Australia
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Funding source category [2]
305391
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Charities/Societies/Foundations
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Name [2]
305391
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Qld Institute of Dermatology
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Address [2]
305391
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10 Browning Street
South Brisbane
Qld 4101
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Country [2]
305391
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Australia
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Primary sponsor type
Individual
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Name
DR ROWLAND NOAKES
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Address
QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
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Country
Australia
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Secondary sponsor category [1]
305632
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None
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Name [1]
305632
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Address [1]
305632
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Country [1]
305632
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305615
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RAMSAY HEALTH CARE QLD HREC
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Ethics committee address [1]
305615
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GREENSLOPES PRIVATE HOSPITAL
NEWDEGATE STREET
GREENSLOPES Q 4120
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Ethics committee country [1]
305615
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Australia
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Date submitted for ethics approval [1]
305615
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11/12/2019
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Approval date [1]
305615
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09/03/2020
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Ethics approval number [1]
305615
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19/37
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Summary
Brief summary
If you agree to participate you will be enrolled into either of two groups. One group will receive A prescribed course of narrow band UVB and the second will trial the combination of the trial lotion with natural sunlight. If you are enrolled in the trial group and fail to respond by 12 weeks or 6 months in the case of vitiligo you will receive a prescribed course of narrowband UVB.
The purpose of this study is to ascertain whether natural sunlight used in combination with the trial lotion produces a similar benefit to narrow band UVB.
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Trial website
Nil
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
100966
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Dr ROWLAND NOAKES
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Address
100966
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QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
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Country
100966
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Australia
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Phone
100966
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+61 419677741
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Fax
100966
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+61 7 3329 4455
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Email
100966
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[email protected]
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Contact person for public queries
Name
100967
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Ms Melita Limberg
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Address
100967
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QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
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Country
100967
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Australia
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Phone
100967
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+61 7 33294400
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Fax
100967
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+61 7 3329 4455
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Email
100967
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[email protected]
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Contact person for scientific queries
Name
100968
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Dr ROWLAND NOAKES
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Address
100968
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QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
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Country
100968
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Australia
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Phone
100968
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+61 419677741
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Fax
100968
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+61 7 3329 4455
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Email
100968
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Privacy
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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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