None listed
Conditions
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.
Interventions
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
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.
Sponsors
Malaghan Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed