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Cromoglicate in Mastocytosis

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ClinicalTrials.gov 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

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.

Condition or disease Intervention/treatment Phase
Mastocytosis Drug: Cromoglicate Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis
Study Start Date : October 2012
Primary Completion Date : February 2013
Study Completion Date : February 2013

Arm Intervention/treatment
Placebo (left) / Cromoglicate (right)
Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside)
Drug: Cromoglicate
Twice daily topical treatment for 14 days
Drug: Placebo
Twice daily topical treatment for 14 days
Placebo (right) / Cromoglicate (left)
Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside)
Drug: Cromoglicate
Twice daily topical treatment for 14 days
Drug: Placebo
Twice daily topical treatment for 14 days

Primary Outcome Measures :
  1. Evaluation of mechanically induced changes of lesions [ Time Frame: Baseline to week 2 ]

Secondary Outcome Measures :
  1. Evaluation of mechanically induced wheal and flare response [ Time Frame: Baseline to week 2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701843

Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin
Berlin, Germany, D-10117
Sponsors and Collaborators
LEO Pharma
Principal Investigator: Frank Siebenhaar, MD Allergie-Centrum-Charité

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01701843     History of Changes
Other Study ID Numbers: LP0074-33
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Skin Diseases
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents