Cutaneous Mastocytosis Clinical Trial
Official title:
Efficacy and Safety of TF002 in Cutaneous Mastocytosis
The current study will investigate the effects of TF002 on cutaneous mastocytosis or cutaneous involvement of systemic mastocytosis as compared to clobetasol proprionate (positive control) and a general skin care product without active ingredient targeting mastocytosis (negative control) based on clinical effects on Darier´s signs and the histological evaluation of mast cell numbers in skin bioptic material.
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
comparator Dermoxinale®.
Since there are no approved therapies for this indication a placebo controlled design was
chosen.
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
control.
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
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