Nail Psoriasis
Conditions
Interventions
Trade Name: Betesil
Product Name: Betamethasone valerate (BMV) 0.1% medicated plaster
Pharmaceutical Form: Medicated plaster
Pharmaceutical form of the
Sponsors
IBSA Institut Biochimique S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age =18 years; 2. diagnosis of nail psoriasis at both hands (nail matrix and bed with psoriatic dystrophy); 3. diagnosis of fingernail psoriasis alone or in association with skin and/or arthritic psoriasis, stable for at least 12 months; 4. Total NAPSI-Right = 12 and Total NAPSI-Left = 12; 5. NAPSI = 4 (nail bed and/or nail matrix disease in each of 4 nail quadrants) for the most severely involved fingernail (i.e. the “target fingernail”) of each hand; 6. negative direct mycological examination and culture for fungus and bacteria before inclusion; 7. written, informed consent signed before any study procedures occur; 8. female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) with a negative urine pregnancy test at inclusion and using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. use of any topical anti-psoriatic medications or ultraviolet treatment for fingernail psoriasis within two months before inclusion; 2. use of manicures or cosmetic nail products during and within seven days before inclusion; 3. initiation or significant change in dose/regimen of any antipsoriatic systemic treatment (i.e. retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) less than two months before inclusion; 4. infected fingernails (bacterial or fungal); 5. skin lesions or dermatological diseases that could interfere with the application of the plaster (e.g. dermatitis, skin ulcers, burns, skin infections, skin atrophy); 6. allergy to the active substance or excipients contained in the tested medication (particularly betamethasone valerate, methyl parahydroxybenzoate and propyl-parahydroxybenzoate); 7. underlying disease or medication that severely compromise the subject's immune system (T-lymphocytes impairment or immunosuppressive therapy); 8. history of anaphylaxis to drugs or allergic reactions in general which the Investigator considers to potentially affect the outcome of the study; 9. severe cardiac, hepatic or renal insufficiency; 10. pregnant or lactating women; 11. history of alcohol or drug abuse (within 12 months before inclusion); 12. clinically significant or unstable concurrent disease whose sequelae or treatment might interfere with the study evaluation parameters; 13. metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the Investigator, could compromise the patient’s participation in the study; 14. patients unable to comprehend the full nature and the purpose of the study, including possible risks and side effects, because of psycho-social or other reasons, and patients unable to cooperate with the Investigator and to comply with the requirement of the entire study (including inability to attend all the planned study visits according to the time limits); 15. concomitant participation in other clinical trials or participation in the evaluation of any investigational drug/device within 3 months before inclusion or previous participation in the present study; 16. the participation in the present study is also not permitted to employees of the Investigator or study centre with direct involvement in the trial or in other trials under the direction of that Investigator, as well as family members of the employees or the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy and safety of Betamethasone valerate (BMV) 0.1% medicated plaster, as compared to placebo plaster, when applied daily at bedtime and during a period of maximum 12 weeks, in patients suffering from nail psoriasis.;Secondary Objective: Secondary objectives are the evaluation of the local tolerability at the site of plaster application, the general safety in terms of adverse events, and the level of patients’ satisfaction with the therapy.;Primary end point(s): Target Nail Psoriasis Severity Index (NAPSI) for the most severely involved fingernail (i.e. the “target fingernail”) of right hand (Target NAPSI Right) and of the left hand (Target NAPSI Left) at the end of treatment period as compared to baseline, considering that one hand will be treated with the test product and the other one with the placebo.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Total NAPSI, •Nail Thickness, •Nail pain VAS, •Patient’s and Physician’s Overall assessment of severity, •Patient’s satisfaction with treatment outcome, •local tolerability, •and adverse events at each control visit as compared to baseline ; Timepoint(s) of evaluation of this end point: 4 weeks 8 weeks 12 weeks Follow-UP (24 weeks) | — |
Countries
Italy
Contacts
Public ContactR&D Department
IBSA Institut Biochimique S.A.
Outcome results
None listed