chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier´s sign MedDRA version: 9.1 Level: LLT Classification code 10012812 Term: Diffuse cutaneous mastocytosis
Conditions
Interventions
Trade Name: Miltex®
Pharmaceutical Form: Cutaneous liquid
INN or Proposed INN: MILTEFOSINE
CAS Number: 58066856
Other descriptive name: Hexadecylphosphocholine
Concentration unit: mg/ml milligram(s)/m
Sponsors
JADO Technologies GmbH
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of miltefosine compared to placebo [note: placebo in this clinical trial is being defined as a liquid reference product used for skin-care in dermatology with similar appearance as miltefosine and with no effect on cutaneous mastocytosis (negative control) (Hametum® Extrakt, see PR3).];Primary end point(s): clinical evaluation of treatment response comparing miltefosin to placebo. Evaluation of mechanically induced changes of lesions (Darier´s Sign) by the investigator using a composite score (Maximum = 9 points) evaluating wheal, erythema and itching each on a 4 point scale (0=no, 1=mild, 2=moderate, 3= severe).;Secondary Objective: To determine the efficacy of miltefosine compared to Dermoxinale® To determine the safety of miltefosine compared to placebo and Dermoxinale® [note: placebo in this clinical trial is being defined as a liquid reference product used for skin-care in dermatology with similar appearance as miltefosine and with no effect on cutaneous mastocytosis (negative control) (Hametum® Extrakt, see PR3).] | — |
Countries
Germany
Outcome results
None listed