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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
7/05/2020
Date data sharing statement initially provided
7/05/2020
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
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
Secondary ID [1] 300814 0
Nil known
Universal Trial Number (UTN)
U1111-1249-8985
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 316697 0
Atopic dermatitis 316698 0
Pruritus 316699 0
Vitiligo 316700 0
Condition category
Condition code
Skin 314941 314941 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 317144 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 323255 0
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
Timepoint [1] 323255 0
12 weeks for psoriasis, atopic dermatitis and pruritus
6 months for vitiligo
Primary outcome [2] 323300 0
A skin biopsy from a light protected and light exposed area will also be taken for immuno-histochemical staining to ascertain cytochrome P450 induction
Timepoint [2] 323300 0
12 weeks for psoriasis, atopic dermatitis and pruritus. 24 weeks for vitiligo
Secondary outcome [1] 381320 0
nil
Timepoint [1] 381320 0
Not applicable

Eligibility
Key inclusion criteria
Adult patients with psoriasis, atopic dermatitis, pruritus or vitiligo eligible for treatment with Narrowband UVB
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
Allocation concealed via central computer randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

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 in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16140 0
Queensland Institute of Dermatology - South Brisbane
Recruitment postcode(s) [1] 29669 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 305270 0
Self funded/Unfunded
Name [1] 305270 0
DR ROWLAND NOAKES
Address [1] 305270 0
QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
Country [1] 305270 0
Australia
Funding source category [2] 305391 0
Charities/Societies/Foundations
Name [2] 305391 0
Qld Institute of Dermatology
Address [2] 305391 0
10 Browning Street
South Brisbane
Qld 4101
Country [2] 305391 0
Australia
Primary sponsor type
Individual
Name
DR ROWLAND NOAKES
Address
QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
Country
Australia
Secondary sponsor category [1] 305632 0
None
Name [1] 305632 0
Address [1] 305632 0
Country [1] 305632 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305615 0
RAMSAY HEALTH CARE QLD HREC
Ethics committee address [1] 305615 0
GREENSLOPES PRIVATE HOSPITAL
NEWDEGATE STREET
GREENSLOPES Q 4120
Ethics committee country [1] 305615 0
Australia
Date submitted for ethics approval [1] 305615 0
11/12/2019
Approval date [1] 305615 0
09/03/2020
Ethics approval number [1] 305615 0
19/37

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.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100966 0
Dr ROWLAND NOAKES
Address 100966 0
QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
Country 100966 0
Australia
Phone 100966 0
+61 419677741
Fax 100966 0
+61 7 3329 4455
Email 100966 0
ky_n_urenine@hotmail.com
Contact person for public queries
Name 100967 0
Ms Jane Parbery
Address 100967 0
QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
Country 100967 0
Australia
Phone 100967 0
+61 7 33294400
Fax 100967 0
+61 7 3329 4455
Email 100967 0
JParbery@qiderm.com.au
Contact person for scientific queries
Name 100968 0
Dr ROWLAND NOAKES
Address 100968 0
QLD INSTITUTE OF DERMATOLOGY
10 BROWNING STREET
SOUTH BRISBANE
QLD 4101
Country 100968 0
Australia
Phone 100968 0
+61 419677741
Fax 100968 0
+61 7 3329 4455
Email 100968 0
ky_n_urenine@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy
What supporting documents are/will be available?
No other documents available
Summary results
No Results