Palmo-Plantar Pustulosis MedDRA version: 16.0 Level: LLT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Toctino 30 mg Weichkapseln
Product Name: alitretinoin
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ALITRETINOIN
CAS Number: 08/03/5300
Concentration unit: mg milligram(s)
Concen
Sponsors
GlaxoSmithKline R&D Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A female subject is eligible to participate if she is of: • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and a follicle-stimulating hormone concentration of ?40 international units (IU)/L. • Child-bearing potential with negative pregnancy test as determined by a human chorionic gonadotropin (hCG) test at screening or prior to dosing and either 1) agrees to use a medically acceptable contraception method for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point and continue contraception until the end of the study, or 2) has only same-sex partners, when this is her preferred and usual lifestyle. 2. Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed. 3. Male or female aged at least 18 years at time of consent and at time of first dose. 4. Have PPP for at least 6 months, with or without psoriasis lesions on other areas of the skin. 5. A PPPASI score of at least 8 with involvement of at least 10% of the palms and/or the soles. 6. Refractory to standard topical corticosteroid therapy. 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
Exclusion criteria: 1. Unable to comply with the requirement of the study. 2. Female subjects who are pregnant or who plan to become pregnant or who are breast feeding. 3. Subjects whose disease is adequately controlled by standard non-medicated therapy (skin moisturizing and protection). 4. Known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil. 5. Treated with any of the following treatments 4 weeks before the start of study treatment: • systemic drugs: corticosteroids, immunosuppressants, methotrexate • phototherapy: ultraviolet B light therapy [UVB], psoralen with ultraviolet A combination therapy [PUVA], Grenz rays, X-rays 6. Treated with biologic treatments within 6 weeks prior to start of study treatment. 7. Abnormal hematology. 8. Treated with any systemic or topical retinoids within 3 months or 1 month, respectively, before start of study treatment. 9. Treated with high-potency topical corticosteroids within 2 weeks before the start of study treatment. 10. Severe generalized pustular psoriasis. 11. A skin condition of palms and/or soles that interferes with the diagnosis of PPP by the investigator. 12. Any condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study. 13. Hepatic insufficiency, severe renal failure, uncontrolled hypercholesterolemia as characterized by: • AST/ ALT > 2.5 x upper limit of normal (ULN) • Creatinine clearance 1.5 x ULN • Fasting cholesterol > 1.5 x ULN • Fasting low-density lipoprotein (LDL) cholesterol > 1.5x ULN 14. Subjects with hypothyroidism as indicated by TSH above ULN and T4 test below LLN or hypervitaminosis A. 15. Subjects with unstable cardiac disease or poorly controlled cardiovascular risk factors, for example: • Acute coronary syndrome or coronary revascularization (PCI, CABG) within 3 months before start of study treatment • Poorly controlled diabetes mellitus (HbA1c > 8.5%) 16. Systolic blood pressure =160 mm Hg and/or diastolic blood pressure =100 mm Hg at the screening examination. 17. Subjects receiving drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John’s Wort within 1 Week, or receiving systemic itraconazole within 2 Weeks, before start of study treatment. 18. Subjects included in the study of an investigational drug within 2 months before start of study treatment (3 months for biologics). 19. Subjects with a score of 20 or more on CES-D, or with active major psychiatric disorder (eg, Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder [I or II], or schizophrenia). 20. Subjects who score a 4 or 5 during the previous 30 days on the CSSRS at Screening or Baseline. 21. Subjects who have made a suicide attempt within the 6 months preceding the Screening or Baseline visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - assess the response to psoriasis lesions in locations other than the hands to treatment - assess the response of nail involvement to treatment - collect safety data;Primary end point(s): PPPASI - calculated for palm or sole. range from 0 (no PPP) to 72 (most severe PPP) assesses erythema, number of pustules, desquamation and area involved. Pustule count - palms and soles Modified Psoriasis Area Severity Index (mPASI) - psoriatic plaques will be evaluated for redness, thickness and scaliness over 4 body regions - head, upper extremities, truck and lower extremities Nail Psorisasis Serverity Index (NAPSI) - taken for finger nails only;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the response of pustular lesions to total pustule count To assess the response to psoriasis lesions in locations other than the hands to the treatment To assess the response of nail involvement to the treatment To collect safety data for alitretinoin;Timepoint(s) of evaluation of this end point: Week 24 or last visit on treatment | — |
Countries
Germany, Netherlands, United Kingdom
Contacts
Public ContactClinical Trials HelpDesk
GlaxoSmithKline R&D Ltd
Outcome results
None listed