Cromoglicate in Mastocytosis
- Registration Number
- NCT01701843
- Lead Sponsor
- LEO Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
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 § 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (left) / Cromoglicate (right) Cromoglicate Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside) Placebo (left) / Cromoglicate (right) Placebo Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside) Placebo (right) / Cromoglicate (left) Cromoglicate Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside) Placebo (right) / Cromoglicate (left) Placebo Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside)
- Primary Outcome Measures
Name Time Method Evaluation of mechanically induced changes of lesions Baseline to week 2
- Secondary Outcome Measures
Name Time Method Evaluation of mechanically induced wheal and flare response Baseline to week 2
Trial Locations
- Locations (1)
Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany