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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
History of Changes
  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:

U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 21, 2013