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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Tecno Sun SRL.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centro Studi Gised
Information provided by (Responsible Party):
Tecno Sun SRL
ClinicalTrials.gov Identifier:
NCT01574872
First received: April 6, 2012
Last updated: April 7, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Inverse Psoriasis
Sebopsoriasis
Device: Halotherapy
Device: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Tecno Sun SRL:

Primary Outcome Measures:
  • Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +) [ Time Frame: 3 weeks (15 sessions), 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any change from baseline of physician's clinical judgment [ Time Frame: 3 weeks (15 sessions), 15 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of reported adverse events [ Time Frame: 3 weeks (15 sessions), 15 weeks ] [ Designated as safety issue: Yes ]
    Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it


Estimated Enrollment: 64
Study Start Date: March 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • halotherapy
  • 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 Names:
  • placebo
  • comparator

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574872

Contacts
Contact: Cornelia Zinetti, sociology +39 0352278719 cornelia.zinetti@gised.it
Contact: Simone Cazzaniga, mathematics +39 0352278719 simone.cazzaniga@gised.it

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

No publications provided

Responsible Party: Tecno Sun SRL
ClinicalTrials.gov Identifier: NCT01574872     History of Changes
Other Study ID Numbers: AEROSAL1
Study First Received: April 6, 2012
Last Updated: April 7, 2012
Health Authority: Italy: Ethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Tecno Sun SRL:
psoriasis
salt
sodium chloride

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

ClinicalTrials.gov processed this record on August 19, 2014