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Efficacy and Safety of TF002 in Cutaneous Mastocytosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457288
First Posted: April 6, 2007
Last Update Posted: November 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
JADO Technologies GmbH
  Purpose
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.

Condition Intervention Phase
Cutaneous Mastocytosis Drug: TF 002 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of TF002 in Cutaneous Mastocytosis

Resource links provided by NLM:


Further study details as provided by JADO Technologies GmbH:

Primary Outcome Measures:
  • Clinical evaluation of treatment response

Secondary Outcome Measures:
  • Number of skin mast cells
  • Volumetric and thermographic analyses

Estimated Enrollment: 30
Study Start Date: April 2007
Study Completion Date: September 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457288


Locations
Germany
Klinik und Poliklinik für Dermatologie und Venerologie der Universität
Köln, Germany, D-50924
Universitäts-Hautklinik
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
Sponsors and Collaborators
JADO Technologies GmbH
Investigators
Principal Investigator: Marcus Maurer, Prof Charite University, Berlin, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00457288     History of Changes
Other Study ID Numbers: MICUMA
First Submitted: April 4, 2007
First Posted: April 6, 2007
Last Update Posted: November 12, 2007
Last Verified: November 2007

Keywords provided by JADO Technologies GmbH:
Cutaneous Mastocytosis
Topical treatment

Additional relevant MeSH terms:
Mastocytosis
Mastocytosis, Cutaneous
Mastocytoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Diseases