search
Back to results

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

Primary Purpose

Inverse Psoriasis, Sebopsoriasis

Status
Withdrawn
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Halotherapy
Placebo
Sponsored by
Tecno Sun SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inverse Psoriasis focused on measuring psoriasis, salt, sodium chloride

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione S.Raffaele del Monte Tabor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aerosal

Placebo

Arm Description

This arm include all patients treated with Aerosal®

This arm include all patients treated with placebo

Outcomes

Primary Outcome Measures

Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)

Secondary Outcome Measures

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)
Overall patient satisfaction
Overall patient satisfaction as assessed by visual analogue scale VAS
Any change from baseline of PASI index
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

Full Information

First Posted
April 6, 2012
Last Updated
November 17, 2014
Sponsor
Tecno Sun SRL
Collaborators
Centro Studi Gised
search

1. Study Identification

Unique Protocol Identification Number
NCT01574872
Brief Title
Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
Official Title
Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Changes in the sponsorship, design and locations of the study
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tecno Sun SRL
Collaborators
Centro Studi Gised

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inverse Psoriasis, Sebopsoriasis
Keywords
psoriasis, salt, sodium chloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerosal
Arm Type
Experimental
Arm Description
This arm include all patients treated with Aerosal®
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This arm include all patients treated with placebo
Intervention Type
Device
Intervention Name(s)
Halotherapy
Other Intervention Name(s)
aerosal, salt, sodium chloride
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)
Time Frame
3 weeks (15 sessions), 15 weeks
Secondary Outcome Measure Information:
Title
Any change from baseline of physician's clinical judgment
Description
Any change from baseline of physician's clinical judgment as assessed by visual analogue scale (VAS)
Time Frame
3 weeks (15 sessions), 15 weeks
Title
Overall patient satisfaction
Description
Overall patient satisfaction as assessed by visual analogue scale VAS
Time Frame
3 weeks (15 sessions), 15 weeks
Title
Any change from baseline of PASI index
Time Frame
3 weeks (15 sessions), 15 weeks
Title
Number of reported adverse events
Description
Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it
Time Frame
3 weeks (15 sessions), 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Naldi, MD
Organizational Affiliation
Centro Studi Gised
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione S.Raffaele del Monte Tabor
City
Milano
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs