Mastocytosis Clinical Trial
Official title:
A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis
Verified date | March 2013 |
Source | LEO Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
The purpose of this exploratory study is to investigate the clinical efficacy of study drug (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded, randomised, single centre setting.
Status | Terminated |
Enrollment | 7 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent has been obtained - Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign - Age between 18 and 70 years - Either sex - Any race or ethnicity - Attending hospital outpatient clinic or the private practice of a dermatologist. Exclusion Criteria: - The presence of autoimmune and infectious disease including aggressive systemic mastocytosis - Medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia - Medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia - Evidence of severe renal dysfunction (creatinine > 1,5 times upper reference value) - Evidence of significant hepatic disease (liver enzymes > 2 times upper reference value) - Presence of active cancer which requires chemotherapy or radiation therapy - Commitment to an institution in terms of ยง 40 Abs. 1 S. 3 Nr. 4 AMG - Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study - Intake of oral corticosteroids within 14 days prior to randomisation - Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to randomisation - Radiation therapy of target areas including UV therapy within 4 weeks prior to randomisation - Confounding other dermatological diseases or conditions that can affect the symptoms of the target areas - Known or suspected hypersensitivity to component(s) of investigational products. - Current participation in any other interventional clinical trial. - Subjects who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half-lives (whichever is longer) prior to randomisation - Previously randomised in this clinical trial - In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state). - Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding. - Females of child-bearing potential with positive pregnancy test at visit 1. - Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
LEO Pharma |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of mechanically induced changes of lesions | Baseline to week 2 | No | |
Secondary | Evaluation of mechanically induced wheal and flare response | Baseline to week 2 | No |
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