A clinical study evaluating the efficacy of topical cromoglicate solution compared to placeboin the treatment of mastocytosis
- Conditions
- mastocytosisMedDRA version: 15.0Level: PTClassification code 10012812Term: Diffuse cutaneous mastocytosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 15.0Level: LLTClassification code 10056452Term: Indolent systemic mastocytosisSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2011-006275-20-DE
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Signed informed consent has been obtained
2.Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocy-tosis with skin involvement and a positive Darier’s Sign
3.Age between 18 and 70 years
4.Either sex
5.Any race or ethnicity
6.Attending hospital outpatient clinic or the private practice of a dermatologist
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
1.The presence of autoimmune and infectious disease including aggressive systemic mastocytosis
2.Medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or is-chemia
3.Medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia
4.Evidence of severe renal dysfunction (creatinine > 1,5 times upper reference value)
5.Evidence of significant hepatic disease (liver enzymes > 2 times upper reference value)
6.Presence of active cancer which requires chemothera-py or radiation therapy
7.Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG
8.Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
9.Intake of oral corticosteroids within 14 days prior to randomisation
10.Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to randomisation
11.Radiation therapy of target areas including UV therapy within 4 weeks prior to randomisation
12.Confounding other dermatological diseases or conditions that can affect the symptoms of the target areas
13.Known or suspected hypersensitivity to component(s) of investigational products.
14.Current participation in any other interventional clinical trial.
15.Subjects who have received treatment with any non-marketed 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
16.Previously randomised in this clinical trial
17.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).
18.Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
19.Females of child-bearing potential with positive pregnancy test at visit 1.
20.Subjects (or their partner) not using an adequate method of contraception (according to national re-quirements, as applicable)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the clinical efficacy of treatment with topical cromoglycate solution in patients with mastocytosis;Secondary Objective: To investigate the safety of treatment with topical cromoglycate solution in patients with mastocytosis;Primary end point(s): Clinical evaluation of treatment response comparing cromoglicate to vehicle. Evaluation of mechanically induced changes of lesions (Darier’s Sign) by the investigator using a composite score (Maximum = 9 points) evaluating wheal, erythema and itching each on a 4 point scale (0= no, 1=mild, 2= moderate, 3= severe) and VAS.;Timepoint(s) of evaluation of this end point: Evaluation on Visit 2 after 14 days on treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline of mechanically induced wheal and flare response comparing cromoglycate to placebo and active. Evaluation by volumetric and thermographic analyses<br>Gene expression<br>Immunohistochemistry <br>;Timepoint(s) of evaluation of this end point: Evaluation on Visit 2 after 14 days on treatment