Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus
AliCLE
1 other identifier
interventional
7
1 country
3
Brief Summary
To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely. Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJune 1, 2016
May 1, 2016
2.7 years
August 1, 2011
May 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely.
Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50")
Week 24 or at the latest assessment for patients who withdrew prematurely.
Secondary Outcomes (5)
Proportion of patients with RCLASI 50 at week 12 of treatment.
Week 12 of treatment
Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions).
End of therapy (up to 24 weeks)
Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment.
12 weeks after the beginning of treatment
Number of Participants with Adverse Events (AEs) and their severity.
24 weeks of treatment + 5 weeks of follow up
Patient's global assessment and VAS for itch and pain at the end of therapy.
End of therapy (up to 24 weeks)
Study Arms (1)
Alitretinoin
EXPERIMENTALInterventions
1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
Eligibility Criteria
You may qualify if:
- A clinical and histological diagnosis of CLE (DLE, SCLE, LET) who failed to respond to topical corticosteroids;
- Total RCLASI activity score of skin lesions \>6 (at least 3 points in at least 2 locations);
- At least one primary but preferably 2 methods of contraception;
You may not qualify if:
- Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease;
- Clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- Active severe infection diseases, including chronic or localized;
- Patients with hepatic insufficiency (AST, ALT \> 2.5 x ULN), severe renal failure (creatinine clearance \< 60ml/min), or hypercholesterolemia characterized by:
- Fasting triglyceridemia \> 1.5 x upper limit of normal (ULN)
- Fasting total cholesterol \> 1.5 x ULN
- Fasting low-density lipoprotein (LDL) cholesterol \> 1.5x ULN
- Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil;
- Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin;
- Topical corticosteroids within 14 days prior to dosing;
- Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment;
- 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;
- Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class and half-life);
- Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
- Concomitant medication with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolbutamide;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Dematology, University Hospital
Mannheim, Baden-Wurttemberg, 68167, Germany
Department of Dermatology, Ludwig-Maximilians University
Munich, Bavaria, 80337, Germany
Department of Dermatology, University Hospital
Münster, Westfalen, 48149, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annegret Kuhn, Prof. Dr.
Department of Dermatology, University Hospital Muenster, Muenster, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2011
First Posted
August 2, 2011
Study Start
August 1, 2011
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
June 1, 2016
Record last verified: 2016-05