Efficacy and Safety of Miltefosine in Cutaneous Mastocytosis - MICUMA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-) Chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier’s Sign
-) 3 comparable lesional areas of at least 50 cm2 excluding areas in the face and intertriginous areas
-) Otherwise healthy according to physical examination
-) Aged >=18 years
-) Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year)
-) Informed consent signed and dated
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-) Clinically significant abnormalities in biochemistry or haematology
-) Agressive systemic mastocytosis
-) History or concomitant retinal pathology
-) 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
-) Target lesions covering breast implants
-) Radiation therapy of target areas excluding UV therapy longer than 4 weeks before start of study treatment
-) Dermal comorbidities within the target areas
-) During the past 3 days before start of treatment and during the study: topical products, Antihistamines (H1 and H2), Leukotriene antagonists
-) During the past 2 weeks before start of treatment and during the study: Ketotifen, Doxepin
-) During the past 4 weeks before start of treatment and during the study: Topical corticosteroids, UV therapy including PUVA, Systemic immunosuppressives including corticosteroids, immunomodulators, immunostimulants
-) During the past 12 weeks before start of treatment and during the study: Astemizole
-) Any concomitant medication which might influence the study objectives or are known to provoke or aggravate mastocytosis
-) Tranquilizers, antidepressants, sedatives, hypnotics, antiepileptics and other CNS active agents
-) Nonsteroidal antiinflammatory drugs