Clinical Trial: Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: JADO Technologies GmbH
Current Primary Outcome: Clinical evaluation of treatment response
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of skin mast cells
- Volumetric and thermographic analyses
Original Secondary Outcome: Same as current
Information By: JADO Technologies GmbH
Dates:
Date Received: April 4, 2007
Date Started: April 2007
Date Completion:
Last Updated: November 9, 2007
Last Verified: November 2007
