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Efficacy and Safety of TF002 in Cutaneous Mastocytosis

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. Identifier: NCT00457288
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : November 12, 2007
Information provided by:
JADO Technologies GmbH

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.

Condition or disease Intervention/treatment Phase
Cutaneous Mastocytosis Drug: TF 002 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Study Start Date : April 2007
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  1. Clinical evaluation of treatment response

Secondary Outcome Measures :
  1. Number of skin mast cells
  2. Volumetric and thermographic analyses

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00457288

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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
Sponsors and Collaborators
JADO Technologies GmbH
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Principal Investigator: Marcus Maurer, Prof Charite University, Berlin, Germany

Layout table for additonal information Identifier: NCT00457288     History of Changes
Other Study ID Numbers: MICUMA
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: November 12, 2007
Last Verified: November 2007
Keywords provided by JADO Technologies GmbH:
Cutaneous Mastocytosis
Topical treatment
Additional relevant MeSH terms:
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Mastocytosis, Cutaneous
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Skin Diseases
Immune Complex Diseases
Immune System Diseases