Efficacy and Safety of TF002 in Cutaneous Mastocytosis
18 Years
N/A
Both
Cutaneous Mastocytosis
Trial Information
Efficacy and Safety of TF002 in Cutaneous Mastocytosis
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Clinical evaluation of treatment response
Principal Investigator
Marcus Maurer, Prof
Investigator Role:
Principal Investigator
Investigator Affiliation:
Charite University, Berlin, Germany
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
MICUMA
NCT ID:
NCT00457288
Start Date:
April 2007
Completion Date:
September 2007
Related Keywords:
- Cutaneous Mastocytosis
- Cutaneous Mastocytosis
- Topical treatment
- Mastocytosis
- Urticaria Pigmentosa
- Mastocytoma
- Mastocytosis, Cutaneous
Name | Location |
|---|
