Nail Psoriasis Clinical Trial
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
Verified date | June 2015 |
Source | Almirall, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.
Status | Completed |
Enrollment | 66 |
Est. completion date | May 2015 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Investigational site 3 | Berlin | |
Germany | Investigational site 4 | Berlin | |
Germany | Investigational 2 | Hamburg | |
Germany | Investigational site 1 | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Almirall, S.A. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | % reduction in the Nail Psoriasis Severity Index ( NAPSI ) | Day85 | No | |
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Day 85 | Yes |
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