Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000249853
Ethics application status
Approved
Date submitted
2/02/2021
Date registered
8/03/2021
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Date results information initially provided
8/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of topical folic acid on skin phototherapy for atopic dermatitis
Scientific title
The impact of topical folic acid prior to UV-B phototherapy on the extent and severity of atopic dermatitis
Secondary ID [1] 303314 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atopic dermatitis 320544 0
Condition category
Condition code
Skin 318398 318398 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim is to determine whether application of a folic acid cream improves standard narrowband UVB (nbUVB; 311nm wavelength) phototherapy for dermatitis. nbUVB therapy is a standard treatment for dermatitis. Patients will receive 3 phototherapy treatments per week and up to 30 treatments in total. Phototherapy will be administered to the whole body, in a standing phototherapy cabinet. Patients will receive a 5% folic acid cream prior to their nbUVB treatment on a 10cm x 10cm lesion and a control emollient on a contralateral lesion of similar size. The folic acid cream is applied less than 30 minutes prior to nbUVB treatment. The locations of the lesions receiving the folic acid cream and the control emollient are noted in each patient's medical records. Each treatment session will last approximately 45 minutes, including up to 15 minutes of phototherapy.
Intervention code [1] 319620 0
Treatment: Other
Intervention code [2] 319867 0
Treatment: Drugs
Comparator / control treatment
The control treatment will be a standard skin emollient (cetomacrogol) with yellow food coloring. The control emollient is applied less than 30 minutes prior to nbUVB treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 326378 0
Eczema Area and Severity Index (EASI) scores of the folic acid pre-treated and control emollient pre-treated areas
Timepoint [1] 326378 0
Patients will be treated with up to 30 nbUVB sessions, according to clinical practice. The EASI scores will be recorded before application of the topical treatments, prior to each phototherapy session.
Secondary outcome [1] 391261 0
none
Timepoint [1] 391261 0
none

Eligibility
Key inclusion criteria
- aged at least 18 at study commencement
- active dermatitis eligible for full body phototherapy as standard treatment.
- ability to stand without help in a full body phototherapy cabinet
- no immunosuppressive drugs taken in the last 6 weeks prior to phototherapy start
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Past skin cancer.
- Unable to stand unaided in the phototherapy cabinet.
- Have a photosensitive cause of dermatitis or taking photosensitizing medicines.
- Having taken immunosuppressant medicines within 6 weeks of study commencement.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/09/2019
Date of last participant enrolment
Anticipated
Actual
3/08/2020
Date of last data collection
Anticipated
Actual
1/12/2020
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 23419 0
New Zealand
State/province [1] 23419 0
Wellington

Funding & Sponsors
Funding source category [1] 307730 0
Other
Name [1] 307730 0
Malaghan Institute of Medical Research
Country [1] 307730 0
New Zealand
Primary sponsor type
Other
Name
Malaghan Institute of Medical Research
Address
Gate 7, Victoria University
Kelburn Parade,
6242 Wellington
New Zealand
Country
New Zealand
Secondary sponsor category [1] 308432 0
None
Name [1] 308432 0
none
Address [1] 308432 0
none
Country [1] 308432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307758 0
Central Health and Disabilities Ethics Committees
Ethics committee address [1] 307758 0
Ministry of Health
Ethics Department Reception - Ground Floor 20 Aitken Street Thorndon
WELLINGTON, 6011
Ethics committee country [1] 307758 0
New Zealand
Date submitted for ethics approval [1] 307758 0
Approval date [1] 307758 0
20/09/2018
Ethics approval number [1] 307758 0

Summary
Brief summary
Atopic dermatitis (AD) is a highly debilitating disease with significant health impacts worldwide. It has been a difficult disease to treat due to the wide spectrum of clinical manifestations. As such, the current clinical management strategies are non-specific. Previous studies have documented that AD disease progression is precipitated by a combination of skin barrier dysfunction, itch and immune dysregulation.
Preclinical observations indicate that the topical application of folic acid (vitamin B9) can enhance the therapeutic efficacy of narrowband ultraviolet therapy by increasing the generation of the folic acid photometabolite 6-formylpterin, which binds to the major histocompatibility complex related molecule 1 (MR1) and thereby inhibits MR1-dependent immune surveillance of the skin and associated inflammatory immune responses. This study is a proof-of-concept study aiming to translate these preclinical findings to human patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108390 0
Dr Olivier Gasser
Address 108390 0
Malaghan Institute of Medical Research
Gate 7, Victoria University
Kelburn Parade,
6242 Wellington
New Zealand
Country 108390 0
New Zealand
Phone 108390 0
+64 44996914
Fax 108390 0
Email 108390 0
[email protected]
Contact person for public queries
Name 108391 0
Dr Olivier Gasser
Address 108391 0
Malaghan Institute of Medical Research
Gate 7, Victoria University
Kelburn Parade,
6242 Wellington
New Zealand
Country 108391 0
New Zealand
Phone 108391 0
+64 44996914
Fax 108391 0
Email 108391 0
[email protected]
Contact person for scientific queries
Name 108392 0
Dr Olivier Gasser
Address 108392 0
Malaghan Institute of Medical Research
Gate 7, Victoria University
Kelburn Parade,
6242 Wellington
New Zealand
Country 108392 0
New Zealand
Phone 108392 0
+64 44996914
Fax 108392 0
Email 108392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification, will be made available upon publication.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access the data.
Available for what types of analyses?
Any analyses
How or where can data be obtained?
Data will be available through the publisher of the research articles.
De-identified data will be made available upon request by email (to Olivier Gasser; Email: [email protected]).


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.