Efficacy and Safety of TF002 in Cutaneous Mastocytosis
1 other identifier
interventional
30
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2007
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 4, 2007
CompletedFirst Posted
Study publicly available on registry
April 6, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedNovember 12, 2007
November 1, 2007
April 4, 2007
November 9, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical evaluation of treatment response
Secondary Outcomes (2)
Number of skin mast cells
Volumetric and thermographic analyses
Interventions
Eligibility Criteria
You may qualify if:
- Chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier's Sign
- comparable skin lesional areas
- Otherwise healthy according to physical examination
- Informed consent signed and dated
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Klinik und Poliklinik für Dermatologie und Venerologie der Universität
Cologne, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus Maurer, Prof
Charite University, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 4, 2007
First Posted
April 6, 2007
Study Start
April 1, 2007
Study Completion
September 1, 2007
Last Updated
November 12, 2007
Record last verified: 2007-11