Inverse Psoriasis, Sebopsoriasis
Conditions
Keywords
psoriasis, salt, sodium chloride
Brief summary
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
Interventions
DEVICEHalotherapy
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.
DEVICEPlacebo
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.
Sponsors
Centro Studi Gised
Tecno Sun SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Inverse Psoriasis or Sebopsoriasis lasting from at one year * At least 1% of total body surface area involvement Suspension for more than 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporin, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)
Exclusion criteria
* Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure * Iodine allergy * Women who are pregnant or planning to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +) | 3 weeks (15 sessions), 15 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any change from baseline of physician's clinical judgment | 3 weeks (15 sessions), 15 weeks | Any change from baseline of physician's clinical judgment as assessed by visual analogue scale (VAS) |
| Overall patient satisfaction | 3 weeks (15 sessions), 15 weeks | Overall patient satisfaction as assessed by visual analogue scale VAS |
| Any change from baseline of PASI index | 3 weeks (15 sessions), 15 weeks | — |
| Number of reported adverse events | 3 weeks (15 sessions), 15 weeks | Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it |
Countries
Italy
Outcome results
None listed