A phase II trial to evaluate the anti-psoriatic efficacy and tolerability of tazarotene in a gel formulation in patients with mild to moderate nail psoriasis - parallel group compariso

• Conditions: patients with mild to moderate nail psoriasis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-004519-28-DE
• Lead Sponsor: Almirall Hermal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-22
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• men and women aged 18 to 75;
• mild to moderate nail psoriasis on one target fingernail (mNAPSI 12 to 50 inclusive at screening and Day 1);
• nail growth of the target fingernail of =1 mm per month;
• the physical examination of the skin including nails must be without further disease findings (other than psoriasis) unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
• subjects with body psoriasis must have chronic, stable, mild to moderate body psoriasis;
• female volunteers of childbearing potential* must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or had a vasectomized partner
• written informed consent obtained.
* Females NOT of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• pustular psoriasis;
• target fingernail thicker than 2 mm at free edge (if necessary, a sliding caliper for measurement of thickness will be used);
• concomitant onychomycosis of the target fingernail shown by negative culture;
• any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;
• history of hypersensitivity to tazarotene or to drugs with similar chemical structures or to other components of the study medication or to the adhesive bandage;
• topical treatment of nails with antipsoriatics (e.g. topical nail application of corticosteroids, retinoids, vitamin D analogues, 5-fluorouracil or anthralin) in the 4 weeks preceding the treatment phase and during the trial including the 3-month follow-up period;
• systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial including the 3-month follow-up period with antipsoriatics e.g. retinoids, cytostatics, corticosteroids, immunosuppressive therapy, or biologics, with the exception of ustekinumab, which should not have been taken within the six months prior to the treatment phase or during the trial.);
• intralesional steroid injection in the nail fold within the three months before the treatment phase of the trial or during the trial;
• phototherapy (including UVB and PUVA) within three months before the treatment phase of the trial;
• treatment with systemic or locally acting medications which might counter or influence the trial aim or medications e.g. those which are known to provoke or aggravate psoriasis, such as antimalarial drugs, lithium, beta-blockers and indomethacin within 4 weeks before the treatment phase of the trial and during the trial;
• any chronic infection or condition capable of interfering with the conduct of the trial;
• evidence of drug or alcohol abuse;
• symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks preceding the treatment phase of the trial;
• participation in the treatment phase of another clinical trial within the last 4 weeks prior to first treatment in this clinical trial;
• pregnancy or nursing;
• in the opinion of the investigator or physician performing the initial examination the patient should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
• close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH, or the patient is an employee of the sponsor;
• patient is institutionalized because of a legal or regulatory order.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to assess the anti-psoriatic efficacy and tolerability of tazarotene in a gel formulation in patients with mild to moderate nail psoriasis compared to the vehicle;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint will be the % change from baseline in mNAPSI of the target fingernail on Day 85. The primary analysis will compare the results for this endpoint for the tazarotene gel 0.1 % (LAS41006) group versus (vs.) the vehicle group.<br>;Timepoint(s) of evaluation of this end point: Day 85

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The changes in the mNAPSI index after 2, 4 and 8 weeks of application will be evaluated along the lines of the primary analysis to assess the onset of treatment effect.;Timepoint(s) of evaluation of this end point: after 2, 4 and 8 weeks of application