The purpose of this study is to evaluate the efficacy of Aerosal® compared to placebo in the prognosis of inverse psoriasis or sebopsoriasis present for at least one year
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
The treatment consist of 15 session of micronized iodized salt (sodium chloride) skin exposure in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes.
The treatment consist of 15 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes.
Fondazione S.Raffaele del Monte Tabor
Milan, Italy
Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)
Time frame: 3 weeks (15 sessions), 15 weeks
Any change from baseline of physician's clinical judgment
Any change from baseline of physician's clinical judgment as assessed by visual analogue scale (VAS)
Time frame: 3 weeks (15 sessions), 15 weeks
Overall patient satisfaction
Overall patient satisfaction as assessed by visual analogue scale VAS
Time frame: 3 weeks (15 sessions), 15 weeks
Any change from baseline of PASI index
Time frame: 3 weeks (15 sessions), 15 weeks
Number of reported adverse events
Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it
Time frame: 3 weeks (15 sessions), 15 weeks
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