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

NCT01574872 | Withdrawn Phase 2 DMC

• 1 other identifier: AEROSAL1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Inverse Psoriasis; Sebopsoriasis

Keywords

psoriasis; salt; sodium chloride

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)

  3 weeks (15 sessions), 15 weeks

Secondary Outcomes (4)

• Any change from baseline of physician's clinical judgment

  3 weeks (15 sessions), 15 weeks

• Overall patient satisfaction

  3 weeks (15 sessions), 15 weeks

• Any change from baseline of PASI index

  3 weeks (15 sessions), 15 weeks

• Number of reported adverse events

  3 weeks (15 sessions), 15 weeks

Study Arms (2)

Aerosal

EXPERIMENTAL

This arm include all patients treated with Aerosal®

Device: Halotherapy

Placebo

PLACEBO COMPARATOR

This arm include all patients treated with placebo

Device: Placebo

Interventions

Halotherapy DEVICE

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.

Also known as: aerosal, salt, sodium chloride

Aerosal

Placebo DEVICE

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.

Also known as: comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tecno Sun SRL: lead
• Centro Studi Gised: collaborator

Study Sites (1)

Fondazione S.Raffaele del Monte Tabor

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Luigi Naldi, MD

  Centro Studi Gised

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 10, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

IT (1)