Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235480
• Other study ID #: H 573 000 1307
• Secondary ID: 2013-004519-28
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2014
• Last updated: June 9, 2015
• Start date: February 2014
• Est. completion date: May 2015

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nail Psoriasis
• Psoriasis

Intervention

Drug:
• Experimental Tazarotene Gel

• Placebo

Locations

Country	Name	City	State
Germany	Investigational site 3	Berlin
Germany	Investigational site 4	Berlin
Germany	Investigational 2	Hamburg
Germany	Investigational site 1	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

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