Efficacy and Safety of TF002 in Cutaneous Mastocytosis

NCT ID: NCT00457288

Last Updated: 2007-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2007-09-30

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.

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.

Conditions

Cutaneous Mastocytosis

Keywords

Cutaneous Mastocytosis; Topical treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

TF 002

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JADO Technologies GmbH

INDUSTRY

Sponsor Role: lead

Principal Investigators

Marcus Maurer, Prof

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Klinik und Poliklinik für Dermatologie und Venerologie der Universität

Cologne, Köln, Germany

Universitäts-Hautklinik

Mainz, , Germany

Klinik und Poliklinik für Dermatologie und Allergologie der LMU

München, , Germany

Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU

München, , Germany

Countries

Germany

Other Identifiers

MICUMA

Identifier Type: -

Identifier Source: org_study_id