Cromoglicate in Mastocytosis (NCT01701843) | Clinical Trial Compass
TerminatedPhase 2
Cromoglicate in Mastocytosis
Stopped: prematurely terminated because of low recruitment
Germany7 participantsStarted 2012-10
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Evaluation of mechanically induced changes of lesions