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

Inverse Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01574872
• Other study ID #: AEROSAL1
• Status: Withdrawn
• Phase: Phase 2
• First received: April 6, 2012
• Last updated: November 17, 2014
• Start date: March 2012
• Est. completion date: April 2013

Study information

• Verified date: November 2014
• Source: Tecno Sun SRL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis, Seborrheic
• Inverse Psoriasis
• Psoriasis
• Sebopsoriasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Fondazione S.Raffaele del Monte Tabor	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Tecno Sun SRL	Centro Studi Gised

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)		3 weeks (15 sessions), 15 weeks	No
Secondary	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)	3 weeks (15 sessions), 15 weeks	No
Secondary	Overall patient satisfaction	Overall patient satisfaction as assessed by visual analogue scale VAS	3 weeks (15 sessions), 15 weeks	No
Secondary	Any change from baseline of PASI index		3 weeks (15 sessions), 15 weeks	No
Secondary	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	3 weeks (15 sessions), 15 weeks	Yes