Cromoglicate in Mastocytosis

NCT ID: NCT01701843

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-02-28

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.

Conditions

Mastocytosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo (left) / Cromoglicate (right)

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

Group Type: OTHER

Cromoglicate

Intervention Type: DRUG

Twice daily topical treatment for 14 days

Placebo

Intervention Type: DRUG

Twice daily topical treatment for 14 days

Placebo (right) / Cromoglicate (left)

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

Group Type: OTHER

Cromoglicate

Intervention Type: DRUG

Twice daily topical treatment for 14 days

Placebo

Intervention Type: DRUG

Twice daily topical treatment for 14 days

Interventions

Cromoglicate

Twice daily topical treatment for 14 days

Intervention Type: DRUG

Placebo

Twice daily topical treatment for 14 days

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Siebenhaar, MD

Role: PRINCIPAL_INVESTIGATOR

Allergie-Centrum-Charité

Locations

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

Berlin, , Germany

Countries

Germany

Other Identifiers

LP0074-33

Identifier Type: -

Identifier Source: org_study_id