Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Information source: JADO Technologies GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cutaneous Mastocytosis
Intervention: TF 002 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: JADO Technologies GmbH Official(s) and/or principal investigator(s): Marcus Maurer, Prof, Principal Investigator, Affiliation: Charite University, Berlin, Germany
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.
Clinical Details
Official title: Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Clinical evaluation of treatment response
Secondary outcome: Number of skin mast cellsVolumetric and thermographic analyses
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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 am Biederstein der TU, München D-80802, Germany
Klinik und Poliklinik für Dermatologie und Allergologie der LMU, München D-80337, Germany
Additional Information
Starting date: April 2007
Last updated: November 9, 2007
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