Alopecia areata MedDRA version: 14.1 Level: PT Classification code 10001761 Term: Alopecia areata System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Fumaderm
Product Name: Fumaderm
Pharmaceutical Form: Tablet
INN or Proposed INN: Dimethylfumarat
CAS Number: 624-49-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
University Hospital Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 to 65 years of age; Able to give a free, informed consent; Diagnosis of chronic, moderate to severe scalp AA, defined as = 20% AA, with a hair loss of at least 6 months' duration; Signed and dated informed consent before the start of specific protocol procedures 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with alopecia totalis, alopecia universalis, or coexisting significant androgenetic alopecia (Norwood-Hamilton stage IV or greater in males, Ludwig stage III in females); Systemic therapies (corticosteroids, fumaric acid derivatives, cyclosporine A, methotrexate, biologic medications, retinoids, azathioprine) and phototherapy (UV-B, PUVA) have to be discontinued for = 1 month prior to and during the entire study treatment period; Topical therapies (corticosteroids, contact sensitizing agents, tacrolimus, or pimecrolimus) have to be discontinued for = 2 weeks prior to and during the entire study treatment period; Pregnant or breastfeeding patients Severe gastrointestinal diseases (Ulcus ventriculi or Ulcus duodeni), kidney disease (creatine clearence > 1.3 mg/dl), severe liver disease (liver enzymes > 2 times maximum of normal range), leucopenia (lympocyte counts < 500 cells / mm²); known allergy against DMF or one of the other components of Fumaderm®/Fumaderm initial®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the therapeutic efficacy defined as the average improvement of the patient’s SALT score at week 24 from baseline.;Secondary Objective: -Participant self-assessment of disease measured on a 7-point qualitative scale, at week 12 and 24, in comparison to baseline -Fumaderm® safety in patients with AA -Effects of Fumaderm® therapy in AA patients on phenotype and function of blood immune cells, through the examination of blood samples taken at baseline, as well as at week 12 and 24 -Immunological analysis and T-cell profiling through histological examination of punch biopsies taken at baseline, as well as week, 12 and 24 -Quality of life ;Primary end point(s): Average improvement of the patient’s SALT score at week 24 from baseline.;Timepoint(s) of evaluation of this end point: Week 12 and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The efficacy shall also be evaluated through self-assessment by the patient at week 12 and 24 on a seven point qualitative scale. - The incidence and grading of adverse events and abnormal laboratory test results will be performed according to CTC-Criteria. - Mononuclear cells, dendritic cells, and CD4+ as well as CD8+ T-cells will be isolated, their phenotype and intracellular cytokine profile analyzed by flow cytometry. Cytokine expression of monocytes and T-cells after stimulation will be quantified through RT-PCR and ELISA. Cytokine and immunohistological studies to analyze the T-cell profile in the punch biopsies of AA patients under Fumaderm® therapy taken at baseline, week 12 and 24 will be performed. - Quality of life will be mesured with the DLQI questionnaire. ;Timepoint(s) of evaluation of this end point: Safety at every visit (every 4 weeks), all other parameters at baseline, week 12 and week 24. | — |
Countries
Germany
Contacts
Public ContactDepartment of Dermatology
University Hospital Tübingen
Outcome results
None listed