Cromoglicate in Mastocytosis

This study has been terminated.
(prematurely terminated because of low recruitment)
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01701843
First received: July 11, 2012
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Mastocytosis
Drug: Cromoglicate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Evaluation of mechanically induced changes of lesions [ Time Frame: Baseline to week 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of mechanically induced wheal and flare response [ Time Frame: Baseline to week 2 ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: October 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: cromoglicate
Drug: Placebo
Twice daily topical treatment for 14 days
Other Name: Placebo
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
Other Name: cromoglicate
Drug: Placebo
Twice daily topical treatment for 14 days
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701843

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

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01701843     History of Changes
Other Study ID Numbers: LP0074-33
Study First Received: July 11, 2012
Last Updated: March 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Urticaria Pigmentosa
Mastocytosis
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Diseases
Mastocytosis, Cutaneous
Pigmentation Disorders
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014