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

November 17, 2014 updated by: Tecno Sun SRL

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20132
        • Fondazione S.Raffaele del Monte Tabor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerosal
This arm include all patients treated with Aerosal®
Device: 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.
Other Names:
  • sodium chloride
  • aerosal
  • salt
Placebo Comparator: Placebo
This arm include all patients treated with placebo
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.
Other Names:
  • comparator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any change from baseline of physician's clinical judgment
Time Frame: 3 weeks (15 sessions), 15 weeks
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
Time Frame: 3 weeks (15 sessions), 15 weeks
Overall patient satisfaction as assessed by visual analogue scale VAS
3 weeks (15 sessions), 15 weeks
Any change from baseline of PASI index
Time Frame: 3 weeks (15 sessions), 15 weeks
3 weeks (15 sessions), 15 weeks
Number of reported adverse events
Time Frame: 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
3 weeks (15 sessions), 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tecno Sun SRL

Collaborators

Centro Studi Gised

Investigators

  • Principal Investigator: Luigi Naldi, MD, Centro Studi Gised

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 7, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEROSAL1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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