Cromoglicate in Mastocytosis

• ClinicalTrials.gov Identifier: NCT01701843
• Recruitment Status: Terminated
• First Posted: October 5, 2012
• Last Update Posted: March 7, 2013
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Study Description

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 Design

• 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
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

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

Additional relevant MeSH terms:

Mastocytosis; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Skin Diseases; Immune Complex Diseases; Hypersensitivity; Immune System Diseases; Cromolyn Sodium; Anti-Asthmatic Agents; Respiratory System Agents