Back to resultsEfficacy and Safety of Tazarotene Gel in Nail Psoriasis
Primary Purpose
Nail Psoriasis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Experimental Tazarotene Gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nail Psoriasis
Eligibility 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;
Sites / Locations
- Investigational site 3
- Investigational site 4
- Investigational 2
- Investigational site 1
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tazarotene Gel
Placebo Gel
Arm Description
once daily
once daily
Outcomes
Primary Outcome Measures
% reduction in the Nail Psoriasis Severity Index ( NAPSI )
Secondary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02235480
Brief Title
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nail Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tazarotene Gel
Arm Type
Experimental
Arm Description
once daily
Arm Title
Placebo Gel
Arm Type
Placebo Comparator
Arm Description
once daily
Intervention Type
Drug
Intervention Name(s)
Experimental Tazarotene Gel
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
% reduction in the Nail Psoriasis Severity Index ( NAPSI )
Time Frame
Day85
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Facility Information:
Facility Name
Investigational site 3
City
Berlin
Country
Germany
Facility Name
Investigational site 4
City
Berlin
Country
Germany
Facility Name
Investigational 2
City
Hamburg
Country
Germany
Facility Name
Investigational site 1
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis
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