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

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ClinicalTrials.gov Identifier: NCT01574872
Recruitment Status : Withdrawn (Changes in the sponsorship, design and locations of the study)
First Posted : April 10, 2012
Last Update Posted : November 18, 2014
Sponsor:
Collaborator:
Centro Studi Gised
Information provided by (Responsible Party):
Tecno Sun SRL

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

Condition or disease Intervention/treatment Phase
Inverse Psoriasis Sebopsoriasis Device: Halotherapy Device: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
Study Start Date : March 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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:
  • aerosal
  • salt
  • sodium chloride

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 Name: comparator




Primary Outcome Measures :
  1. Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +) [ Time Frame: 3 weeks (15 sessions), 15 weeks ]

Secondary Outcome Measures :
  1. 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)

  2. Overall patient satisfaction [ Time Frame: 3 weeks (15 sessions), 15 weeks ]
    Overall patient satisfaction as assessed by visual analogue scale VAS

  3. Any change from baseline of PASI index [ Time Frame: 3 weeks (15 sessions), 15 weeks ]
  4. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574872


Locations
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Italy
Fondazione S.Raffaele del Monte Tabor
Milano, Italy, 20132
Sponsors and Collaborators
Tecno Sun SRL
Centro Studi Gised
Investigators
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Principal Investigator: Luigi Naldi, MD Centro Studi Gised

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Responsible Party: Tecno Sun SRL
ClinicalTrials.gov Identifier: NCT01574872     History of Changes
Other Study ID Numbers: AEROSAL1
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Tecno Sun SRL:
psoriasis
salt
sodium chloride

Additional relevant MeSH terms:
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Psoriasis
Dermatitis, Seborrheic
Skin Diseases, Papulosquamous
Skin Diseases
Dermatitis
Sebaceous Gland Diseases
Skin Diseases, Eczematous