- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00457288
Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Köln, Germany, D-50924
- Klinik und Poliklinik für Dermatologie und Venerologie der Universität
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Mainz, Germany, D-55131
- Universitäts-Hautklinik
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München, Germany, D-80337
- Klinik und Poliklinik für Dermatologie und Allergologie der LMU
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München, Germany, D-80802
- Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical evaluation of treatment response
|
Secondary Outcome Measures
Outcome Measure |
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Number of skin mast cells
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Volumetric and thermographic analyses
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcus Maurer, Prof, Charite University, Berlin, Germany
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MICUMA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cutaneous Mastocytosis
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University Hospital, ToulouseNot yet recruiting
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Joseph ButterfieldRecruitingCutaneous MastocytosesUnited States
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University Hospital, ToulouseCompletedIndolent Systemic Mastocytosis | Cutaneous MastocytosisFrance
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University Hospital, ToulouseUnknown
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University of MinnesotaCompletedUrticaria Pigmentosa | Cutaneous MastocytosisUnited States
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Medical College of WisconsinSociety for Pediatric DermatologyCompleted
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Blueprint Medicines CorporationActive, not recruitingIndolent Systemic MastocytosisCanada, United States, Spain, United Kingdom, Germany, Belgium, Switzerland, Italy, Netherlands, Denmark, France, Norway, Sweden
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AB ScienceRecruitingIndolent Systemic MastocytosisFrance, Netherlands, Germany, United Kingdom, Russian Federation, Poland, Romania, Ukraine
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Allakos Inc.CompletedIndolent Systemic MastocytosisGermany
-
University Hospital, ToulouseRecruitingMastocytosis, Indolent SystemicFrance
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