Efficacy and Safety of Tazarotene Gel in Nail Psoriasis
Information source: Almirall, S.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nail Psoriasis
Intervention: Experimental Tazarotene Gel (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Almirall, S.A.
Summary
The aim of this study is to determine the efficacy and safety of topical application of the
gel compared to placebo in nail psoriasis.
Clinical Details
Official title: A Phase II Trial to Evaluate the Anti-psoriatic Efficacy and Tolerability of Tazarotene in a Gel Formulation in Patients With Mild to Moderate Nail Psoriasis - Parallel Group Comparison
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: % reduction in the Nail Psoriasis Severity Index ( NAPSI )
Secondary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Key inclusion criteria:
- Mild to moderate nail psoriasis on at least one fingernail
Exclusion Criteria:
Key exclusion criteria:
- any other skin condition, with a potential to affect the nails or to interfere with
evaluation of the disease;
- history of hypersensitivity to retinoids or to other components of the trial
medication
- topical treatment of nails with antipsoriatics in the 4 weeks preceding the
treatment phase;
- systemic treatment of psoriasis within the three months before the treatment phase of
the trial or during the trial
- intralesional steroid injection before the treatment phase of the trial
- phototherapy before the treatment phase of the trial;
- any chronic infection or condition capable of interfering with the conduct of the
trial;
- evidence of drug or alcohol abuse;
- symptoms of a clinically significant illness that may influence the outcome of the
trial in the four weeks preceding the treatment phase of the trial;
- participation in another clinical trial within the last 4 weeks prior to first
treatment in this clinical trial;
- pregnancy or nursing;
Locations and Contacts
Investigational site 3, Berlin, Germany
Investigational site 4, Berlin, Germany
Investigational 2, Hamburg, Germany
Investigational site 1, Hamburg, Germany
Additional Information
Starting date: February 2014
Last updated: June 9, 2015
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