Cromoglicate in Mastocytosis

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.

• Drug: Cromoglicate
  Twice daily topical treatment for 14 days
  Other Name: cromoglicate
• Drug: Placebo
  Twice daily topical treatment for 14 days
  Other Name: Placebo

• Placebo (left) / Cromoglicate (right)
  Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside)
  Interventions:

  • Drug: Cromoglicate
  • Drug: Placebo
• Placebo (right) / Cromoglicate (left)
  Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside)
  Interventions:

  • Drug: Cromoglicate
  • Drug: Placebo

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)