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Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

Information source: Almirall, S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nail Psoriasis

Intervention: Experimental Tazarotene Gel (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Almirall, S.A.

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.

Clinical Details

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

Primary outcome: % reduction in the Nail Psoriasis Severity Index ( NAPSI )

Secondary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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;

Locations and Contacts

Investigational site 3, Berlin, Germany

Investigational site 4, Berlin, Germany

Investigational 2, Hamburg, Germany

Investigational site 1, Hamburg, Germany

Additional Information

Starting date: February 2014
Last updated: June 9, 2015

Page last updated: August 23, 2015

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