Status:
COMPLETED
Efficacy and Safety of TF002 in Cutaneous Mastocytosis
Lead Sponsor:
JADO Technologies GmbH
Conditions:
Cutaneous Mastocytosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 gener...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00457288
Start Date
April 1 2007
End Date
September 1 2007
Last Update
November 12 2007
Active Locations (4)
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1
Klinik und Poliklinik für Dermatologie und Venerologie der Universität
Cologne, Köln, Germany, D-50924
2
Universitäts-Hautklinik
Mainz, Germany, D-55131
3
Klinik und Poliklinik für Dermatologie und Allergologie der LMU
München, Germany, D-80337
4
Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU
München, Germany, D-80802