A Phase 3 interventional study of P-3073 (calcipotriene 0.005%) and Vehicle of P-3073 in Nail Psoriasis, sponsored by Polichem S.A.. Withdrawn at 58 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by Polichem S.A. · Phase 3, Interventional, and Treatment
The objective of this phase III study is to evaluate the efficacy, systemic safety and local tolerability of P-3073 (calcipotriene 0.005%) nail solution in patients with mild to moderate psoriatic fingernail/s.
This phase III study versus vehicle will be conducted to confirm the clinical efficacy and safety of P-3073 in patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and concomitant mild-to-moderate plaque psoriasis.
The evaluation of the primary endpoint will be made using the Nail Psoriasis Severity Index (NAPSI).
The secondary objectives will be:
The study consists of two arms comparing P-3073 (calcipotriene 0.005%) and vehicle. Eligible patients will be randomized to either P-3073 or placebo in a 1:1 ratio, stratified by their target nail NAPSI severity at screening.
The study population will include at least 470 patients (235 for each group) with nail psoriasis (fingernails) of the matrix and/or of the nail bed in at least one fingernail.
The total duration of the trial for each patient will be approximately 29 weeks (from Screening to Follow-up). During the 24 weeks of the treatment period, patients will apply the assigned treatment to all affected psoriatic fingernails once daily.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
Browse Psoriasis studies →Polichem S.A. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Additional exclusion criteria for females only:
Drug: P-3073 (calcipotriene 0.005%)
Drug: Vehicle of P-3073
Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.
Once daily for 24 weeks.
Proportion of patients with clear target nail at Week 24
Defined as Nail Psoriasis Severity Index (NAPSI) =0
Time frame: Week 24
Proportion of affected nails at baseline with NAPSI=0 at Week 24
Defined as affected nails with NAPSI=0
Time frame: Baseline - Week 24
Proportion of patients with clear target nail bed at Week 24
Defined as nail bed in NAPSI=0
Time frame: Baseline - Week 24
Proportion of patients with clear target nail matrix at Week 24
Defined as nail matrix in NAPSI=0
Time frame: Baseline - Week 24
Proportion of patients with target nail reaching NAPSI-75%
Defined as a reduction of ≥75% from baseline NAPSI score
Time frame: Baseline - Week 24
Proportion of affected nails at baseline reaching NAPSI-75%
Defined as a reduction of ≥75% from baseline NAPSI score
Time frame: Baseline - Week 24
Change from Baseline in Total NAPSI at Week 24
Defined as change in Nail Psoriasis Severity Index
Time frame: Baseline - Week 24
Time to reach NAPSI=0 in the target nail
Defined as time until NAPSI=0
Time frame: Up to Week 24
Proportion of affected nails at baseline becoming nail Physician Global Assessment (PGA) responder at Week 24
Defined as Nail PGA response rate
Time frame: Baseline - Week 24
Change from Baseline in Nail Psoriasis Visual Analogue Scale (VAS) Discomfort at Week 24
Defined as change in VAS
Time frame: Baseline - Week 24
Patient Acceptance of Study Therapy at Week 24
Note: Missing values will be replaced with the worst score
Time frame: Baseline - Week 24
Change from Baseline in EuroQoL-5Dimensions-5Levels (EQ-5D-5L) at Week 24
Defined as change in EQ-5D-5L
Time frame: Baseline - Week 24
Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 24
Defined as change in DLQI
Time frame: Baseline - Week 24
Change from Baseline in Short Form 36 Health Survey (SF-36) at Week 24
Defined as change in SF-36
Time frame: Baseline - Week 24
Change from Baseline in Nail Psoriasis Quality of Life Index (NPQ10) at Week 24
Defined as change in NPQ10
Time frame: Baseline - Week 24
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Polichem S.A.