Efficacy and Safety of TF002 in Cutaneous Mastocytosis

November 9, 2007 updated by: JADO Technologies GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Köln, Germany, D-50924
        • Klinik und Poliklinik für Dermatologie und Venerologie der Universität
      • Mainz, Germany, D-55131
        • Universitäts-Hautklinik
      • München, Germany, D-80337
        • Klinik und Poliklinik für Dermatologie und Allergologie der LMU
      • München, Germany, D-80802
        • Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier's Sign
  • 3 comparable skin lesional areas
  • Otherwise healthy according to physical examination
  • Informed consent signed and dated

Exclusion Criteria:

  • Aggressive systemic mastocytosis
  • Other dermatological diseases at treated skin site
  • Known hypersensitivity to study drugs or their components
  • Mental disorders
  • Drug or alcohol dependency
  • Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study in the 4 weeks before start of treatment and during the study (investigator's decision).
  • Immunodeficiency including HIV
  • Pregnancy or lactation
  • Participation in another clinical trial within the last 30 days
  • Malignant skin lesions
  • Radiation therapy of target areas excluding UV therapy longer then 4 weeks before start of study treatment
  • Dermal comorbidities within the target areas
  • Any concomitant medication which might influence the study objectives or are known to provoke or aggravate mastocytosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical evaluation of treatment response

Secondary Outcome Measures

Outcome Measure
Number of skin mast cells
Volumetric and thermographic analyses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JADO Technologies GmbH

Investigators

  • Principal Investigator: Marcus Maurer, Prof, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Estimate)

November 12, 2007

Last Update Submitted That Met QC Criteria

November 9, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICUMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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