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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

July 11, 2012
March 6, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01701843 on ClinicalTrials.gov Archive Site
Evaluation of mechanically induced wheal and flare response [ Time Frame: Baseline to week 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Mastocytosis
  • 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 (left) / Cromoglicate (right)
    Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside)
    Interventions:
    • Drug: Cromoglicate
    • Drug: Placebo
  • Placebo (right) / Cromoglicate (left)
    Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside)
    Interventions:
    • Drug: Cromoglicate
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01701843
LP0074-33
No
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