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.

Study Overview

• Status: Terminated
• Conditions: Mastocytosis
• Intervention / Treatment: Drug: Cromoglicate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, D-10117
    • Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of mechanically induced changes of lesions	Baseline to week 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of mechanically induced wheal and flare response	Baseline to week 2

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Frank Siebenhaar, MD, Allergie-Centrum-Charité

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: October 4, 2012
• First Posted (Estimate): October 5, 2012

Study Record Updates

• Last Update Posted (Estimate): March 7, 2013
• Last Update Submitted That Met QC Criteria: March 6, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Hypersensitivity; Neoplasms, Connective Tissue; Immune Complex Diseases; Mastocytosis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunologic Factors; Anti-Asthmatic Agents; Respiratory System Agents; Mast Cell Stabilizers; Cromolyn Sodium
• Other Study ID Numbers: LP0074-33