Treatment of therapy resistant Alopecia areata with fumaric acid esters (Fumaderm® and Fumaderm initial®) – an open, single center, non-randomized, pilot study with 40 patients

Conditions: Alopecia areata
MedDRA version: 14.1Level: PTClassification code 10001761Term: Alopecia areataSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2011-000659-18-DE

Lead Sponsor: niversity Hospital Tübingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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®