mastocytosis MedDRA version: 15.0 Level: PT Classification code 10012812 Term: Diffuse cutaneous mastocytosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 15.0 Level: LLT Classification code 10056452 Term: Indolent systemic mastocytosis System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Como-Stulln UD
Product Name: Cromo-Stulln UD
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: CROMOGLICATE SODIUM
CAS Number: 15826-37-6
Current Sponsor code: LP0075
Concentrat
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Gene expression Immunohistochemistry ;Timepoint(s) of evaluation of this end point: Evaluation on Visit 2 after 14 days on treatment | — |
Countries
Germany
Contacts
Public ContactInternational Clinical Development
LEO Pharma A/S
Outcome results
None listed