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

NCT ID: NCT01574872

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-04-30

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

Detailed Description

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Conditions

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Inverse Psoriasis Sebopsoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Aerosal

This arm include all patients treated with Aerosal®

Group Type EXPERIMENTAL

Halotherapy

Intervention Type 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.

Placebo

This arm include all patients treated with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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Halotherapy

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.

Intervention Type DEVICE

Placebo

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.

Intervention Type DEVICE

Other Intervention Names

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aerosal salt sodium chloride comparator

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Studi Gised

OTHER

Sponsor Role collaborator

Tecno Sun SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luigi Naldi, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Studi Gised

Locations

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Fondazione S.Raffaele del Monte Tabor

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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AEROSAL1

Identifier Type: -

Identifier Source: org_study_id