NCT01574872
Withdrawn
Phase 2
Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
Tecno Sun SRL1 site in 1 countryMarch 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Inverse Psoriasis
- Sponsor
- Tecno Sun SRL
- Locations
- 1
- Primary Endpoint
- Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
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
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)
Time Frame: 3 weeks (15 sessions), 15 weeks
Secondary Outcomes
- Overall patient satisfaction(3 weeks (15 sessions), 15 weeks)
- Any change from baseline of physician's clinical judgment(3 weeks (15 sessions), 15 weeks)
- Number of reported adverse events(3 weeks (15 sessions), 15 weeks)
- Any change from baseline of PASI index(3 weeks (15 sessions), 15 weeks)
Study Sites (1)
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