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Trial record 1 of 34 for:    "Cutaneous mastocytosis"
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Efficacy and Safety of TF002 in Cutaneous Mastocytosis

This study has been completed.
Sponsor:
Information provided by:
JADO Technologies GmbH
ClinicalTrials.gov Identifier:
NCT00457288
First received: April 4, 2007
Last updated: November 9, 2007
Last verified: November 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of TF002 in Cutaneous Mastocytosis

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00457288     History of Changes
Other Study ID Numbers: MICUMA
Study First Received: April 4, 2007
Last Updated: November 9, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by JADO Technologies GmbH:
Cutaneous Mastocytosis
Topical treatment

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

ClinicalTrials.gov processed this record on May 21, 2013