Efficacy and Safety of TF002 in Cutaneous Mastocytosis

Cutaneous Mastocytosis Clinical Trial

Official title:

Efficacy and Safety of TF002 in Cutaneous Mastocytosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457288
• Other study ID #: MICUMA
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2007
• Last updated: November 9, 2007
• Start date: April 2007
• Est. completion date: September 2007

Study information

• Verified date: November 2007
• Source: JADO Technologies GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Mastocytosis
• Mastocytosis

Intervention

Drug:
• TF 002

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Dermatologie und Venerologie der Universität	Köln
Germany	Universitäts-Hautklinik	Mainz
Germany	Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU	München
Germany	Klinik und Poliklinik für Dermatologie und Allergologie der LMU	München

Sponsors (1)

Lead Sponsor	Collaborator
JADO Technologies GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation of treatment response
Secondary	Number of skin mast cells
Secondary	Volumetric and thermographic analyses