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Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

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Almirall

Status and phase

Completed
Phase 2

Conditions

Nail Psoriasis

Treatments

Drug: Experimental Tazarotene Gel
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02235480
H 573 000 1307
2013-004519-28 (EudraCT Number)

Details and patient eligibility

About

The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.

Enrollment

66 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups, including a placebo group

Tazarotene Gel
Experimental group
Description:
once daily
Treatment:
Drug: Experimental Tazarotene Gel
Placebo Gel
Placebo Comparator group
Description:
once daily
Treatment:
Drug: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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