Efficacy of altiretinoin treatment in patients with pustular form of Psoriasis

Phase 1

• Conditions: Palmo-Plantar Pustulosis; MedDRA version: 20.0 Level: LLT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2010-022843-39-GB
• Lead Sponsor: GlaxoSmithKline R&D Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-15
• Study Completion: 2014-04-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

1. Male patients, or females patients if post menopausal as defined 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 treatment
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 paritally 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 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 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) systolic blood pressure >= 160mmHg 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, B

Study & Design

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