Efficacy and safety of 0,1%, 0,5% and 1% TAZAROTENE nail lacquer formulation versus vehicle in nail psoriasis. International, multicenter, double-blind, randomized study of four parallel groups. - Dose ranging for Tazarotene nail lacquer

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-004825-87-DE
• Date of registration: 16/03/2005
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre
• Public title: Efficacy and safety of 0,1%, 0,5% and 1% TAZAROTENE nail lacquer formulation versus vehicle in nail psoriasis. International, multicenter, double-blind, randomized study of four parallel groups. - Dose ranging for Tazarotene nail lacquer
• Scientific title: Efficacy and safety of 0,1%, 0,5% and 1% TAZAROTENE nail lacquer formulation versus vehicle in nail psoriasis. International, multicenter, double-blind, randomized study of four parallel groups. - Dose ranging for Tazarotene nail lacquer
• Date of first enrolment: 04/05/2005
• Target sample size: 184
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004825-87
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Germany, Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
·Patient aged 18 years or over,
·Patient with a personal history of a cutaneous psoriasis,
·Patient with at least four nails with a minimal severity level defined as an onycholysis at least 25% or subungual hyperkeratosis at least 2 mm,
·Patient with a negative urine pregnancy test at inclusion for women of childbearing potential and using an efficient contraceptive (oral contraceptive, IUD, or tubal surgery)
·Patient accepting to participate in the study and to give written informed consent,
·For french patient : patient registered with the French Social Security, in agreement with the French law on biomedical experimentation.
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 clinical diagnosis of onychomycosis or suspicion of an onychomycosis,
·Patient who has had a topical treatment for nail psoriasis within one month prior to the study (corticoids, retinoids, vitamin D derivatives),
·Patient who has had a systemic treatment for psoriasis (biologics, methotrexate, cyclosporin, retinoids, PUVAtherapy ) 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,
·Female who is pregnant, or breastfeeding, or not using contraception, or planning to become pregnant,
·Patient with a history of hypersensitivity to at least one ingredient of the test product,
·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 clinically significant laboratory abnormalities in investigator’s judgement of transaminases or cholesterol (total and HDL) or triglycerides,
·Patient who is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,
·Patient unwilling to give written informed consent,
·Patient who has forfeited his/her freedom by administrative or legal decision or who is under guardianship,
·Participation in another clinical trial in the month preceding inclusion.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psoriasis of the skin is frequently accompanied by nail changes: between 10 and 78% of psoriatic patients suffer from changes of the nails. More than 50% of patients with nail psoriasis have pain because of nail changes, and nearly 60% experience limitations in daily activities. Conventional therapies (e.g., topical agents, triamcinolone acetonide injections, cyclosporine, methotrexate, retinoids, and phototherapy) have limited efficacy, and many have tolerability concerns.
MedDRA version: 7.1 Level: PT Classification code 10028703

Intervention(s)

Product Name: TAZAROTENE
Product Code: R0002
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: TAZAROTENE
Current Sponsor code: R0002
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0,1-
Pharmaceutical form of the placebo: Medicated nail lacquer
Route of administration of the placebo: Topical use (Noncurrent)

Product Name: TAZAROTENE
Product Code: R0002
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: TAZAROTENE
Current Sponsor code: R0002
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0,5-
Pharmaceutical form of the placebo: Medicated nail lacquer
Route of administration of the placebo: Topical use (Noncurrent)

Product Name: TAZAROTENE
Product Code: R0002
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: TAZAROTENE
Current Sponsor code: R0002
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Medicated nail lacquer
Route of administration of the placebo: Topical use (Noncurrent)

Primary Outcome(s)

Primary end point(s): The primary endpoint will be the Blinded Expert Global Assessment (EPGA) from Photographs at 6 months and on a 6-point scale :
1=Clear 2=Excellent 3=Good 4=Fair 5=Poor 6=Worse

Secondary Objective: - To assess the efficacy every 6 weeks using Baran’s Total Clinical Score and Investigator Physician Global Assessment (IPGA).
- To assess the efficacy of a 3-month daily application using EPGA.
- To assess relapse at 3 months after the end of treatment.
- To assess local and general safety of the test product at each visit.
- To collect the Patient Self Assessment at 3 and 6 months.

Main Objective: To assess the efficacy of a 6-month daily application of 0.1% , 0.5% and 1% tazarotene fingernail lacquer in fingernail psoriasis, using Expert Physician Global Assessment (EPGA) corresponding to a blinded assessment of photographs using a 6-point scale.

Secondary ID(s)

R00002 VE 201

2004-004825-87-HU