NCT Number: NCT02235480
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis
The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Investigational site 3, Berlin, Germany
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
Treatment and study plan
Placebo
DrugPrimary outcomes
-
% reduction in the Nail Psoriasis Severity Index ( NAPSI )
Time frame: Day85
Secondary outcomes
-
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 85
Sponsors and collaborators
Lead sponsor
Almirall, S.A.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2015
- First posted
- Sep 10, 2014
- Registry last updated
- Jun 10, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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