EUCTR2004‐004825‐87‐HU.

Trial name or title	Efficacy and safety of 0.1%, 0.5% and 1% tazarotene nail lacquer formulation versus vehicle in nail psoriasis. International, multicenter, double‐blind, randomized study of four parallel groups. ‐ Dose ranging for tazarotene nail lacquer
Methods	This is a double‐blind, randomised study of 4 parallel groups, assessing the application of 0.1%, 0.5%, or 1% tazarotene fingernail lacquer 6‐month daily in fingernail psoriasis.
Participants	Inclusion criteria of the trial Participants are aged 18 years or over with a history of cutaneous psoriasis. Participants have at least 4 nails with a minimal severity level defined as onycholysis of at least 25% or subungual hyperkeratosis at least 2 mm.
Interventions	Application of 0.1%, 0.5%, or 1% tazarotene fingernail lacquer for 6 months daily
Outcomes	Primary outcomes of the trial Main objective: to assess the efficacy of a 6‐month daily application of 0.1%, 0.5%, or 1% tazarotene fingernail lacquer in fingernail psoriasis, using Expert Physician Global Assesment (EPGA) corresponding to a blinded assessment of photographs using a 6‐point scale Primary end point(s): Blinded Expert Global Assesment (EPGA) from photographs at 6 months on a 6‐point scale: 1 = clear, 2 = excellent, 3 = good, 4 = fair, 5 = poor, 6 = worse Secondary outcomes of the trial To assess the efficacy every 6 weeks using Baran's Total Clinical Score and Investigator Physician Global Assessment (IPGA) To assess the efficacy of a 3‐month daily application using EPGA To assess relapse at 3 months after the end of the treatment To assess local and general safety of the test product at each visit To collect the participant self‐assessment at 3 and 6 months
Starting date	22 April 2005
Contact information	Pierre Fabre Dermatology represented by Institut de Recherche Pierre Fabre
Notes	Status: not recruiting