Cromoglicate in Mastocytosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01701843
Recruitment Status : Terminated (prematurely terminated because of low recruitment)
First Posted : October 5, 2012
Last Update Posted : March 7, 2013
Information provided by (Responsible Party):
LEO Pharma

July 11, 2012
October 5, 2012
March 7, 2013
October 2012
February 2013   (Final data collection date for primary outcome measure)
Evaluation of mechanically induced changes of lesions [ Time Frame: Baseline to week 2 ]
Same as current
Complete list of historical versions of study NCT01701843 on Archive Site
Evaluation of mechanically induced wheal and flare response [ Time Frame: Baseline to week 2 ]
Same as current
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Cromoglicate in Mastocytosis
A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of 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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Drug: Cromoglicate
    Twice daily topical treatment for 14 days
  • Drug: Placebo
    Twice daily topical treatment for 14 days
  • Placebo (left) / Cromoglicate (right)
    Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside)
    • Drug: Cromoglicate
    • Drug: Placebo
  • Placebo (right) / Cromoglicate (left)
    Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside)
    • Drug: Cromoglicate
    • Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2013
February 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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LEO Pharma
LEO Pharma
Not Provided
Principal Investigator: Frank Siebenhaar, MD Allergie-Centrum-Charité
LEO Pharma
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP