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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 April 2019 |
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Main ID: |
EUCTR2006-006569-18-FR |
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Date of registration:
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19/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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EFFICACY AND SAFETY OF 8% CLOBETASOL NAIL LACQUER FORMULATION VERSUS VEHICLE IN NAIL PSORIASIS
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Scientific title:
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EFFICACY AND SAFETY OF 8% CLOBETASOL NAIL LACQUER FORMULATION VERSUS VEHICLE IN NAIL PSORIASIS |
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Date of first enrolment:
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16/03/2007 |
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Target sample size:
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30 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006569-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind: yes
Parallel group:
Cross over:
Other: yes
Other trial design description: intra-individual
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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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:
· 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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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NAIL PSORIASIS
MedDRA version: 9.1
Level: PT
Classification code 10028703
Term: Nail psoriasis
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Intervention(s)
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Product Name: Clobetasol propionate 8% (m/m) medicated nail lacquer
Product Code: V0074 VE 04A
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: CLOBETASOL PROPIONATE
CAS Number: 25122467
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 8-
Pharmaceutical form of the placebo: Medicated nail lacquer
Route of administration of the placebo: Cutaneous use
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Primary Outcome(s)
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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
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Secondary Objective: 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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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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Secondary ID(s)
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V00074 VE 202 04A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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