Cromoglicate in Mastocytosis

NCT01701843 | Terminated Phase 2

• 1 other identifier: LP0074-33
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of mechanically induced changes of lesions

  Baseline to week 2

Secondary Outcomes (1)

• Evaluation of mechanically induced wheal and flare response

  Baseline to week 2

Study Arms (2)

Placebo (left) / Cromoglicate (right)

OTHER

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

Drug: Cromoglicate; Drug: Placebo

Placebo (right) / Cromoglicate (left)

OTHER

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

Drug: Cromoglicate; Drug: Placebo

Interventions

Cromoglicate DRUG

Twice daily topical treatment for 14 days

Placebo (left) / Cromoglicate (right); Placebo (right) / Cromoglicate (left)

Placebo DRUG

Twice daily topical treatment for 14 days

Placebo (left) / Cromoglicate (right); Placebo (right) / Cromoglicate (left)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

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

Berlin, D-10117, Germany

Location

MeSH Terms

Conditions

Mastocytosis

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Mast Cell Activation Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Frank Siebenhaar, MD

  Allergie-Centrum-Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: October 5, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 24, 2025

Record last verified: 2013-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)