Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis

Study Overview
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Brief Summary
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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

Official Title
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Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis

Conditions
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Inverse Psoriasis, Sebopsoriasis

Intervention / Treatment
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* Device: Halotherapy
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerosal<br>This arm include all patients treated with Aerosal® | Device: Halotherapy<br>* 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.<br>* Other names: sodium chloride;|
| Placebo Comparator: Placebo<br>This arm include all patients treated with placebo | Device: Placebo<br>* 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.<br>* Other names: comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +) |  | 3 weeks (15 sessions), 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, salt, sodium chloride