Efficacy and Safety of TF002 in Cutaneous Mastocytosis
This is a randomised, double-blind, placebo- and active-controlled study with
intra-individual comparison of test areas.
The primary study target is to evaluate the safety and efficacy of TF002 for the treatment
of cutaneous mastocytosis or systemic mastocytosis with skin involvment. The treatment
period of 14 days was adjusted to the maximum recommended treatment period for the
Since there are no approved therapies for this indication a placebo controlled design was
There are some reports about transient treatment effects using high potent steroids like
clobetasol in mastocytosis. This triggered the decision to use Dermoxinale® as positive
To validate the clinical scores used in the study, surrogate markers describing the Darier´s
sign (thermography, volumetric test) will be evaluated optionally.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Clinical evaluation of treatment response
Marcus Maurer, Prof
Charite University, Berlin, Germany
Germany: Federal Institute for Drugs and Medical Devices