Efficacy and Safety of TF002 in Cutaneous Mastocytosis
|ClinicalTrials.gov Identifier: NCT00457288|
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : November 12, 2007
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Mastocytosis||Drug: TF 002||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Efficacy and Safety of TF002 in Cutaneous Mastocytosis|
|Study Start Date :||April 2007|
|Study Completion Date :||September 2007|
- Clinical evaluation of treatment response
- Number of skin mast cells
- Volumetric and thermographic analyses
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457288
|Klinik und Poliklinik für Dermatologie und Venerologie der Universität|
|Köln, Germany, D-50924|
|Mainz, Germany, D-55131|
|Klinik und Poliklinik für Dermatologie und Allergologie der LMU|
|München, Germany, D-80337|
|Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU|
|München, Germany, D-80802|
|Principal Investigator:||Marcus Maurer, Prof||Charite University, Berlin, Germany|