| Trial name or title |
A randomized, double blind, placebo controlled, parallel groups, pilot study to assess the effects of two new nail lacquers, cyclosporine 5% and calcipotriol 0.005%, in the treatment of nail psoriasis ‐ ND |
| Methods |
This is a randomised, double‐blind, placebo‐controlled, parallel‐group pilot study assessing the application of 2 new nail lacquers, ciclosporin 5% and calcipotriol 0.005%. |
| Participants |
Inclusion criteria of the trial
Participants are men and women aged 18 to 80 years, who have a clinical diagnosis of mild to moderate psoriasis (BSA involvement = 10% or PASI =10), have nail psoriasis (fingernails) of the nail matrix, the nail bed affecting at least 1 nail, or both. There is presence of at least 1 clinical sign of nail psoriasis of the matrix (pitting, leukonychia, red spots in lunula, nail plate crumbling), of the nail bed (salmon patch, onycholysis, hyperkeratosis, and splinter haemorrhage), or both in at least 1 nail.
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| Interventions |
Topical ciclosporin 5% Calcipotriol 0.005% |
| Outcomes |
Primary outcomes of the trial
Main objective: to evaluate the changes of clinical signs of nail bed and of the nail matrix of the nails affected by psoriasis by means of NAPSI score at the end of treatment, at each study visit, and at the follow‐up visit (12 weeks after the end of treatment) To evaluate the changes of nail thickness of the affected nails by means of 20 MHz ultrasound at the end of treatment, at each study visit, and at the end of the follow‐up period (12 weeks after the end of treatment) Evaluation of the safety profile of P‐3072 and P‐3073 at the end of treatment and at each study visit by means of adverse effects monitoring To evaluate the changes in participants' quality of life at the end of treatment, at each study visit, and at the end of the follow‐up period (12 weeks after the end of treatment) To evaluate the changes in pain due to nail psoriasis To evaluate the changes in discomfort due to nail psoriasis To evaluate participants' opinion on the product (effectiveness and acceptability) at the end of treatment Primary end point(s):
Changes in clinical signs of the nail bed (salmon patch, onycholysis, hyperkeratosis, and splinter haemorrhage) and of the nail matrix (pitting, leukonychia, red spots in lunula, and nail plate crumbling) of the affected nails evaluated by means of NAPSI score at the end of treatment, at each study visit, and at the follow‐up visit Changes of nail thickness of the affected nails evaluated by means of 20 MHz ultrasound at the end of treatment, at each study visit, and at the end of the follow‐up period Evaluation of the safety profile of P‐3072 and P‐3073 at each study visit by means of adverse effect monitoring Changes in participants' quality of life by means of NPQ10 (Nail Psoriasis Quality of Life) and DLQI (Dermatology Life Quality Index) questionnaires evaluated at each study visit Changes of pain due to nail psoriasis by means of a VAS (Visual Analogue Scale) Changes of discomfort due to nail psoriasis by means of a VAS (Visual Analogue Scale) Participants' opinion on the product effectiveness and on its acceptability evaluated at each study visit by means of participants' diaries Blood and nail concentration of ciclosporin and calcipotriol at the end of treatment, at each study visit, and at the end of the follow‐up period
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| Starting date |
27 July 2010 |
| Contact information |
Polichem |
| Notes |
Status: Authorised ‐ recruitment may be ongoing or finished |
