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Trial record 30 of 51 for:    tazarotene

Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02235480
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : June 10, 2015
Information provided by (Responsible Party):
Almirall, S.A.

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.

Condition or disease Intervention/treatment Phase
Nail Psoriasis Drug: Experimental Tazarotene Gel Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: Tazarotene Gel
once daily
Drug: Experimental Tazarotene Gel
Placebo Comparator: Placebo Gel
once daily
Drug: Placebo

Primary Outcome Measures :
  1. % reduction in the Nail Psoriasis Severity Index ( NAPSI ) [ Time Frame: Day85 ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 85 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02235480

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Investigational site 3
Berlin, Germany
Investigational site 4
Berlin, Germany
Investigational 2
Hamburg, Germany
Investigational site 1
Hamburg, Germany
Sponsors and Collaborators
Almirall, S.A.

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Responsible Party: Almirall, S.A. Identifier: NCT02235480     History of Changes
Other Study ID Numbers: H 573 000 1307
2013-004519-28 ( EudraCT Number )
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Nicotinic Acids
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs