Efficacy and Safety of TF002 in Cutaneous Mastocytosis - Full Text View

Sponsor:	JADO Technologies GmbH
Information provided by:	JADO Technologies GmbH
ClinicalTrials.gov Identifier:	NCT00457288

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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
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
Klinik und Poliklinik für Dermatologie und Venerologie der Universität
Köln, Germany, D-50924

Sponsors and Collaborators

JADO Technologies GmbH

Investigators

Principal Investigator:

Marcus Maurer, Prof

Charite Berlin

More Information

No publications provided

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

Keywords provided by JADO Technologies GmbH:

Cutaneous Mastocytosis
Topical treatment

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Skin Diseases

Mastocytoma
Mastocytosis
Neoplasms, Connective Tissue
Mastocytosis, Cutaneous

ClinicalTrials.gov processed this record on February 08, 2010