Cromoglicate in Mastocytosis

Study Overview
=================
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.

Official Title
-----------------
A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis

Conditions
-----------------
Mastocytosis

Intervention / Treatment
-----------------
* Drug: Cromoglicate
* Drug: Placebo


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo (left) / Cromoglicate (right)<br>Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside) | Drug: Cromoglicate<br>* Twice daily topical treatment for 14 days<br>Drug: Placebo<br>* Twice daily topical treatment for 14 days<br>|
| Other: Placebo (right) / Cromoglicate (left)<br>Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside) | Drug: Cromoglicate<br>* Twice daily topical treatment for 14 days<br>Drug: Placebo<br>* Twice daily topical treatment for 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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