Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

NCT02235480 | Completed Phase 2

• 2 other identifiers: H 573 000 13072013-004519-28
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

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.

Conditions

Nail Psoriasis

Outcome Measures

Primary Outcomes (1)

• % reduction in the Nail Psoriasis Severity Index ( NAPSI )

  Day85

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Day 85

Study Arms (2)

Tazarotene Gel

EXPERIMENTAL

once daily

Drug: Experimental Tazarotene Gel

Placebo Gel

PLACEBO COMPARATOR

once daily

Drug: Placebo

Interventions

Experimental Tazarotene Gel DRUG

Tazarotene Gel

Placebo DRUG

Placebo Gel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate nail psoriasis on at least one fingernail

You may not qualify if:

• 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;

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (4)

Investigational site 3

Berlin, Germany

Location

Investigational site 4

Berlin, Germany

Location

Investigational 2

Hamburg, Germany

Location

Investigational site 1

Hamburg, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: September 10, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2015
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

DE (4)