Mastocytosis Clinical Trial
Official title:
Study on Mastocytosis for Rupatadine Treatment An Exploratory Phase IV, Randomised, Double-blind, Placebo Controlled Crossover Study to Assess the Efficacy of 20 mg Rupatadine on the Treatment of
Study title:
An exploratory, randomised, double-blind, placebo controlled crossover study to assess the
efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms.
Study code:
SMART-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to §
40 Abs. 4 AMG) Dr. med. F. Siebenhaar, Prof. Dr. Med. M. Maurer, Allergie-Centrum-Charité,
Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1,
D-10117 Berlin Biometry and biostatistical analyses Division of Biostatistics and Clinical
Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin
Monitoring Coordination Centre for Clinical Studies (KKS), Charité - Universitätsmedizin
Berlin, Charitéplatz 1, D-10117 Berlin Clinical phase Phase II
Primary objective:
Reduction of wheal and flare type skin reaction after standardised provocation testing
assessed by volumetric and thermographic measurements.
Secondary objectives:
Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as
assessed by symptom score, DLQI, Itchy-QoL and VAS.
Study design:
An exploratory, randomised, double-blind, placebo controlled crossover study
Type and number of patients:
Male and female patients (n = 30) with cutaneous mastocytosis and indolent systemic
mastocytosis with skin involvement
Main criteria for inclusion:
Mastocytosis patients aged 18-65 years, signed written consent, no systemic corticosteroid
or other immunosuppressive therapy, no permanent severe diseases Test product, dose and mode
of administration 20 mg Rupatadine or placebo before provocation testing, oral
administration (tablets)
Duration of treatment:
28 days (testing will be done at the day of last treatment)
Assessment of efficacy:
1. Assessment of wheal and flare development by planimetric analyses of digital
photographic, volumetric, and thermographic imaging (time lapse) before and after
treatment with study medication,
2. Additional assessment of symptoms,
3. Assessment of life quality
Main criteria of evaluation:
Efficacy
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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