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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Recruitment Status : Withdrawn (Changes in the sponsorship, design and locations of the study)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

Tracking Information
First Submitted Date  ICMJE April 6, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date November 18, 2014
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2012)
Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +) [ Time Frame: 3 weeks (15 sessions), 15 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2012)
  • 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)
  • Overall patient satisfaction [ Time Frame: 3 weeks (15 sessions), 15 weeks ]
    Overall patient satisfaction as assessed by visual analogue scale VAS
  • Any change from baseline of PASI index [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
Official Title  ICMJE Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Inverse Psoriasis
  • Sebopsoriasis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Aerosal
    This arm include all patients treated with Aerosal®
    Intervention: Device: Halotherapy
  • Placebo Comparator: Placebo
    This arm include all patients treated with placebo
    Intervention: Device: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 17, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2012)
64
Estimated Study Completion Date  ICMJE April 2013
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574872
Other Study ID Numbers  ICMJE AEROSAL1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tecno Sun SRL
Study Sponsor  ICMJE Tecno Sun SRL
Collaborators  ICMJE Centro Studi Gised
Investigators  ICMJE
Principal Investigator: Luigi Naldi, MD Centro Studi Gised
PRS Account Tecno Sun SRL
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP