Suspended

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

What is being tested

Cromoglicate

+ Placebo

+ Cromoglicate

Drug

Who is being recruted

Mast Cell Activation Disorders+4

+ Immune System Diseases

+ Neoplasms

From 18 to 70 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: October 2012

See protocol details

Summary

Principal SponsorLEO Pharma

Last updated: February 24, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01701843

Principal SponsorLEO Pharma

Last updated: February 24, 2025

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mast Cell Activation DisordersImmune System DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueMastocytosis

Criteria

6 inclusion criteria required to participate

Age between 18 and 70 years

Any race or ethnicity

Attending hospital outpatient clinic or the private practice of a dermatologist

Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign

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20 exclusion criteria prevent from participating

Commitment to an institution in terms of 40 Abs. 1 S. 3 Nr. 4 AMG

Confounding other dermatological diseases or conditions that can affect the symptoms of the target areas

Current participation in any other interventional clinical trial

Evidence of severe renal dysfunction (creatinine > 1,5 times upper reference value)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside)

Group II

Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin

Berlin, GermanyOpen Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin in Google Maps

SuspendedOne Study Center