NAIL PSORIASIS MedDRA version: 9.1 Level: PT Classification code 10028703 Term: Nail psoriasis
Conditions
Interventions
Product Name: Clobetasol propionate 8% (m/m) medicated nail lacquer
Product Code: V0074 VE 04A
Pharmaceutical Form: Medicated nail lacquer
INN or Propos
Sponsors
PIERRE FABRE DERMATOLOGIE represented by INSTITUT DE RECHERCHE PIERRE FABRE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Over 18 year-old male or female ambulatory patient, · Patient with an history of psoriasis skin disease for at least 6 months, · Patient with bilateral fingernail psoriatic involvement on both hands, · Patient with at least one fingernail psoriatic involvement per hand, · Patient with at least one nail per hand (target nail), with an onycholysis area > 25% or/and a subungual hyperkeratosis > 2 mm. The target nail should be on the same finger of each hand (eg both thumbs), · Patient accepting not to use any product in the same indication during the study period, · Negative urine pregnancy test at inclusion for women of childbearing potential and using an efficient contraceptive (oral contraceptive, intra-uterine device, tubal ligature) for at least 2 months before the study, · Patient accepting to participate to the study and to give a written informed consent, · Registered with a social security or health insurance system. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Patient with a non psoriasis nail disease, · Patient who has had a topical treatment for nail psoriasis within one month prior to the inclusion visit (corticoids, retinoids, vitamin D derivatives), · Patient who has had a systemic treatment for psoriasis (biologics, methotrexate, cyclosporin, retinoids, PUVA therapy) within one month prior to the inclusion visit, · Patient who has had an injection of corticosteroids in the nail within two months prior to the inclusion visit, · Patient who has started or modified a treatment with beta-blockers within two months prior to the inclusion visit, · Patient who has a history of major medical/psychiatric illness or surgery which, in the judgment of the investigator, may interfere with study medication metabolism and/or study implementation and/or study parameter assessment, · Patient with a history of hypersensitivity to at least one ingredient of the test product, · Patient who is a family member or a work associate (secretary, nurse, technician) of the investigator, · Female who is pregnant, or breastfeeding, or not using contraception, or planning to become pregnant, · Participation in another clinical trial within one month prior to the inclusion visit, · Patient who is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent, · Patient who has forfeited his/her freedom by administrative or legal decision or who is under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ; Secondary Objective: Secondary objective : To assess local and general safety of 8% clobetasol fingernail lacquer; To assess systemic exposure of clobetasol 6 months treatment. ; 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 Onycholysis Hyperkeratosis Healthy nails :Number of cured nails Healthy hands : Number of cured hands Patient global self-assessment Tolerance Clobetasol dosage : plasmatic clobetasol measurement at baseline, 3 and 6 months. | — |
Countries
France
Outcome results
None listed