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

Phase 2

Withdrawn

• Conditions: Sebopsoriasis; Inverse Psoriasis
• Interventions: Device: Placebo; Device: Halotherapy

• Registration Number: NCT01574872
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-07
• Study First Posted: 2012-04-10
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	This arm include all patients treated with placebo
Aerosal	Halotherapy	This arm include all patients treated with Aerosal®

Primary Outcome Measures

Name	Time	Method
Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)	3 weeks (15 sessions), 15 weeks

Secondary Outcome Measures

Name	Time	Method
Overall patient satisfaction	3 weeks (15 sessions), 15 weeks	Overall patient satisfaction as assessed by visual analogue scale VAS
Any change from baseline of physician's clinical judgment	3 weeks (15 sessions), 15 weeks	Any change from baseline of physician's clinical judgment as assessed by visual analogue scale (VAS)
Number of reported adverse events	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
Any change from baseline of PASI index	3 weeks (15 sessions), 15 weeks

Trial Locations

Locations (1)

Fondazione S.Raffaele del Monte Tabor; 🇮🇹 Milano, Italy