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Changes in the sponsorship, design and locations of the study
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| Name | Class |
|---|---|
| Centro Studi Gised | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerosal | Experimental | This arm include all patients treated with Aerosal® |
|
| Placebo | Placebo Comparator | This arm include all patients treated with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halotherapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +) | 3 weeks (15 sessions), 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 weeks (15 sessions), 15 weeks |
| Overall patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Naldi, MD | Centro Studi Gised | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione S.Raffaele del Monte Tabor | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Device | 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. |
|
|
Overall patient satisfaction as assessed by visual analogue scale VAS
| 3 weeks (15 sessions), 15 weeks |
| Any change from baseline of PASI index | 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 | 3 weeks (15 sessions), 15 weeks |