Efficacy of Alitretinoin Treatment in Patients With Pustular Form of Psoriasis

NCT ID: NCT01245140

Last Updated: 2017-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-26
• Study Completion Date: 2014-04-16

Brief Summary

The main purpose of this study is to demonstrate the improvement in the skin condition rate of patients receiving alitretinoin compared to patients receiving placebo.

Detailed Description

Palmo-plantar pustulosis (PPP) is an inflammatory skin disease affecting palms and soles. The disease is considered as a sub-form of psoriasis and presents with sterile pustules of the palms and the soles. This study investigates the efficacy of alitretinoin in patients who have not responded to topical drugs (e.g., steroid creams), who are suffering for at least 6 month from the condition and whose disease severity is confirmed by a score.

Conditions

Psoriasis

Keywords

Palmo-Plantar Pustolosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

to receive study drug (alitretinoin, 20 patients)

Group Type: ACTIVE_COMPARATOR

alitretinoin

Intervention Type: DRUG

to receive verum (20 patients)

Placebo

to receive placebo (dummy drug, 10 patients)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

to receive placebo (10 patients)

Interventions

alitretinoin

to receive verum (20 patients)

Intervention Type: DRUG

Placebo

to receive placebo (10 patients)

Intervention Type: DRUG

Other Intervention Names

Toctino

Eligibility 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 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

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 <60 mL/min (calculated, Cockcroft-Gault)
• Fasting triglyceridemia >1.5 x upper limit of normal (ULN)
• Fasting cholesterol >1.5 x ULN
• Fasting low-density lipoprotein (LDL) cholesterol >1.5x ULN

14. Subjects with hypothyroidism as indicated by thyroid stimulating hormone (TSH) above ULN and thyroxine (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 (percutaneous coronary intervention [PCI], coronary artery bypass graft [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 the Center for Epidemiologic Studies Depression scale (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 for the previous 30 days on the Columbia Suicide Severity Rating Scale (CSSRS) at Screening or Baseline

21. Subjects who have made a suicide attempt within the 6 months preceding the Screening or Baseline visits

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: collaborator

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Paris, , France

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Witten, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Nijmegen, , Netherlands

GSK Investigational Site

London, , United Kingdom

Countries

France; Germany; Netherlands; United Kingdom

Study Documents

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

2010-022843-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BAP02028

Identifier Type: OTHER

Identifier Source: secondary_id

117221

Identifier Type: -

Identifier Source: org_study_id