E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028703 |
E.1.2 | Term | Nail psoriasis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective 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 |
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E.2.2 | Secondary objectives of the trial |
Secondary objective : To assess local and general safety of 8% clobetasol fingernail lacquer; To assess systemic exposure of clobetasol 6 months treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |