| Trial name or title |
Efficacy and safety of 8% clobetasol nail lacquer formulation versus vehicle in nail psoriasis |
| Methods |
This is a randomised, double‐blind, placebo‐controlled trial assessing the efficacy of a 6‐month daily application of 8% clobetasol nail lacquer versus vehicle in fingernail psoriasis using the dynamic physician (blinded expert) global assessment (EPGA), the dynamic physician (investigator) global assessment (IPGA), and the patient global self assessment. |
| Participants |
Inclusion criteria of the trial
Participants are 18 years or older, men or women, and ambulatory participants. They have a history of having ‐ for the last 6 months ‐ bilateral fingernail psoriatic involvement on both hands. At least 1 fingernail with psoriatic involvement per hand, at least 1 nail per hand (target nail) with an onycholysis area > 25%, a subungual hyperkeratosis > 2 mm, or both. The target nail should be on the same finger of each hand.
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| Interventions |
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| Outcomes |
Primary outcomes of the trial
Main objective: to assess the efficacy of a 6‐month daily application of 8% clobetasol nail lacquer versus vehicle in fingernail psoriasis using the dynamic physician (blinded expert) global assessment (EPGA), the dynamic physician (investigator) global assessment (IPGA), and the patient global self assessment Primary end point(s): dynamic PGA: 1) dEPGA (dynamic expert PGA), 2) dIPGA (dynamic investigator PGA); Static PGA: 1) sEPGA (static expert PGA), 2) sIPGA (static investigator PGA) Total clinical score assessing onycholysis, hyperkeratosis, healthy nail, number of cured nails, healthy hands, number of cured hands, patients global self assessment, tolerance to clobetasol dosage, plasmatic clobetasol measurement at baseline and 3 and 6 months
Secondary outcomes of the trial
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| Starting date |
19 January 2007 |
| Contact information |
Pierre Fabre Dermatology represented by Institut de Recherche Pierre Fabre |
| Notes |
Status: Authorised ‐ recruitment may be ongoing or finished |
