None listed
Conditions
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.
Interventions
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 do
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
Sponsors
DR ROWLAND NOAKES
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients with psoriasis, atopic dermatitis, pruritus or vitiligo eligible for treatment with Narrowband UVB
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
Outcome results
None listed