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A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis

Phase 2
18 Years
70 Years
Not Enrolling

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Trial Information

A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis

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

- 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
to randomisation

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Evaluation of mechanically induced changes of lesions

Outcome Time Frame:

Baseline to week 2

Safety Issue:


Principal Investigator

Frank Siebenhaar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 2012

Completion Date:

February 2013

Related Keywords:

  • Mastocytosis
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma