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CompletedNCT00457288Updated Nov 12, 2007

Efficacy and Safety of TF002 in Cutaneous Mastocytosis

A Phase 2 interventional study of TF 002 in Cutaneous Mastocytosis, sponsored by JADO Technologies GmbH. Completed at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-12.

Sponsored by JADO Technologies GmbH · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cutaneous Mastocytosis

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Keywords

  • Cutaneous Mastocytosis
  • Topical treatment
03

In context

Mastocytosis

75 studies on the registry are indexed under Mastocytosis; 16 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 41 interventional studies indexed under Mastocytosis.

Browse Mastocytosis studies →

Lead sponsor

This is the only study on the registry with JADO Technologies GmbH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
30 participants (estimated)

Interventions

  • DrugTF 002
06

What researchers measure

Primary outcomes

  1. Clinical evaluation of treatment response

Secondary outcomes

  1. Number of skin mast cells

  2. Volumetric and thermographic analyses

07

Study locations

4 sites
  • Klinik und Poliklinik für Dermatologie und Venerologie der Universität
    Köln, D-50924, Germany
  • Universitäts-Hautklinik
    Mainz, D-55131, Germany
  • Klinik und Poliklinik für Dermatologie und Allergologie der LMU
    München, D-80337, Germany
  • Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU
    München, D-80802, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00457288
Lead sponsor
JADO Technologies GmbH
First posted
Apr 6, 2007
Start date
Apr 2007
Completion
Sep 2007
Last update
Nov 12, 2007

Study contacts

Marcus Maurer, Prof
principal investigator · Charite University, Berlin, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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