Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Primary Purpose
Cutaneous Mastocytosis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
TF 002
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Mastocytosis focused on measuring Cutaneous Mastocytosis, Topical treatment
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
Sites / Locations
- Klinik und Poliklinik für Dermatologie und Venerologie der Universität
- Universitäts-Hautklinik
- Klinik und Poliklinik für Dermatologie und Allergologie der LMU
- Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU
Outcomes
Primary Outcome Measures
Clinical evaluation of treatment response
Secondary Outcome Measures
Number of skin mast cells
Volumetric and thermographic analyses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00457288
Brief Title
Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Official Title
Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
JADO Technologies GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Mastocytosis
Keywords
Cutaneous Mastocytosis, Topical treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TF 002
Primary Outcome Measure Information:
Title
Clinical evaluation of treatment response
Secondary Outcome Measure Information:
Title
Number of skin mast cells
Title
Volumetric and thermographic analyses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Maurer, Prof
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik und Poliklinik für Dermatologie und Venerologie der Universität
City
Köln
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Universitäts-Hautklinik
City
Mainz
ZIP/Postal Code
D-55131
Country
Germany
Facility Name
Klinik und Poliklinik für Dermatologie und Allergologie der LMU
City
München
ZIP/Postal Code
D-80337
Country
Germany
Facility Name
Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU
City
München
ZIP/Postal Code
D-80802
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of TF002 in Cutaneous Mastocytosis
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