Efficacy of alitretinoin treatment in patients with pustular form of Psoriasis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Male patients, or females patients if post menopausal as desribed in protocol section 7.4.1, or hysterectomized, or bilaterally ovarectomized or if pre-menopausal and willing to use at least 1 but preferrably 2 methods of contraception under supervision of the investigator or a gynecologist
2. Aged 18 to 75 years
3. Patients with PPP for at least 6 months, with or without psoriasis lesions on other areas of the skin
4. A PPPASI score of at least 8 with involvement of at lest 10% of the palms and/or the soles
5. Refractory to standard topical therapy
6. Written informed consent provided
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Patients unable to comply with the requirements of the study
2. Female patients who are pregnant or who plan to become pregnant or who are breastfeeding
3. Female patients of childbearing potential who cannot use or will not commit to using at least 1 but preferrably 2 effective forms of contraception simultaneously under supervision of the investigator or a gynecologist
4. Patients whose disease is adequately controlled by standard non-medicated therapy (skin moisturizing and protection) and standard topical corticosteriod therapy, but whose disease has relapsed following discontinuation of these treatments
5. Patients with known hypersensitivity to other retinoids or Vitamin A derivatives, or to any study medication component, especially soybean oil and partially hydrogenated soybean oil
6. Patients treated with any of the following treatments 4 weeks before the start of the study treatment
a) systemic drugs: corticosteroids, immunosuppressants, methotrexate
b) phototherapy: ultraviolet B light therapy (UVB), Psoralen with ultraviolet A combination therapy (PUVA), Grenz rays, X-rays
7. Patients treated with biologic treatment within 12 weeks prior to the start of study treatment
8. Patients treated with any systemic or topical retinoids within 1 year or 1 month, respectively, before start of study treatment, and patients who received systemic retinoids for treatment for PPP at any time
9. Patients with severe generalised pustular psoriasis
10. Patient has a skin condition of palms and / or soles assessed as unrelated to PPP by the investigator
11. Patients with any serious medical condition which, in the opinion of the investigator, may interfere with the safety of the patient
12. Patients with hepatic insufficiency, severe renal failure, uncontrolled hypercholesterolemia, uncontrolled as characterized by:
a. AST / ALT > 2.5 x ULN
b. Creatinine Clearance < 60ml/min (calc. Cockcroft Gault)
c. Fasting triglyceridemia > 1.5 x ULN
d. Fasting cholesterol >1.5 x ULN
e. fasting LDL cholesterol > 1.5x ULN
13. Patients with hypothyroidism as indicated by TSH above ULN and T4 test below LLN or hypervitaminosis A
14. Patients with unstable cardiac disease or poorly controlled cardiovascular risk factors, i.e.:
a) acute coronary syndrome or coronary revascularization (PCI, CABG) within 3 months before start of study treatment
b) poorly controlled diabetes mellitus (HbA1c > 8.5%)
c) systolica blood pressure >= 16-0 mmHg and/or diastolic blood pressure >= 100mmHg at the screening examination
15. Patients receiving drugs with a potential for drug-drug interactions, such as systemic tetracyclines, ketoconazole, St Johns Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before the start of study treatment
16. Patients included in the study of an investigational drug within 2 months before start of study treatment (3 months for biologics)
17. Patients with a score of 20 or more on CES-D or active major psychiatric disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder, Biopolar Disorder (I or II), or schizophrenia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the response, based on the palmo-plantar pustulosis psoriasis area and severity index (PPPASI) at the end of treatment (week 24).;Secondary Objective: - assess the response of pustular lesions to total pustular count<br>- assess the response to psoriasis lesions in locations other than the hands to treatment<br>- assess the response of nail involvement to treatment<br>- collect safety data;Primary end point(s): PPPASI - calculated for palm or sole. range from 0 (no PPP) to 72 (most severe PPP)<br>assesses erythema, number of pustules, desquamation and area involved.<br><br>Pustule count - palms and soles<br><br>Modified Psoriasis Area Severity Index (mPASI) - psoriatic plaques will be evaluated for redness, thickness and scaliness over 4 body regions - head, upper extremities, trunk and lower extremities<br><br>Nail Psorisasis Serverity Index (NAPSI) - taken for finger nails only;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess the response of pustular lesions to total pustule count<br>To assess the response to psoriasis lesions in locations other than the hands to the treatment<br>To assess the response of nail involvement to the treatment<br>To collect safety data for alitretinoin;Timepoint(s) of evaluation of this end point: Week 24 or last visit on treatment