A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis
- 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.
- The presence of autoimmune and infectious disease including aggressive systemic
- 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
- 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
- Radiation therapy of target areas including UV therapy within 4 weeks prior to
- 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)