Patients with haematomas and subcutaneous haematic extravasations of traumatic origin MedDRA version: 9.1 Level: LLT Classification code 10042345 Term: Subcutaneous haematoma
Conditions
Interventions
Trade Name: CLAREMA*CREMA 30G 1%
Pharmaceutical Form: Cream
INN or Proposed INN: Organo-heparinoid
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-
Trade Name: HIRUDOI
Sponsors
FARMACEUTICI DAMOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained; 2. Outpatients of either sex, aged between 18 and 75 years; 3. Evidence of a post-traumatic haematoma and/or haematic extravasation with onset from ≤ 3 days (in case of multiple non-confluent haematomas, the largest one will be selected); 4. Size of the haematoma and/or haematic extravasation around ≥ 2x2 cm (approximately 4 cm2) and ≤ 20x20 cm (approximately 400 cm2); 5. Presence of at least two subjective symptoms and/or objective signs of haematoma and/or haematic extravasation of at least moderate degree (i.e. with score ≥ 2); 6. Patient?s co-operative attitude and able to understand and adhere to study protocol procedures and timelines. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History or current evidence of inherited or acquired coagulation disorders (of any type); 2. Patients being treated with anticoagulant, fibrinolytic, antiplatelet or hemorheologic agents, or with concomitant drugs potentially acting on coagulation or platelet aggregation parameters; 3. Patients being treated with steroidal and non-steroidal anti-inflammatory drugs (NSAIDs); 4. History or current evidence of cardiovascular diseases, e.g. congestive heart failure NYHA class > 1, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; 5. History or current evidence of liver (i.e. AST/ALT higher than twice the upper limit of normal range) or renal (i.e. creatinine > 2 mg/dl) insufficiency, of metabolic or endocrine diseases (e.g. uncontrolled diabetes mellitus), or of any other underlying medical condition that might interfere with the study evaluation parameters; 6. Immunocompromised patients; 7. Evidence of cutaneous lesions, such as wounds, ulcers, sores etc, or other skin diseases that impair the skin integrity of the surface selected for treatment; 8. Evidence of serious concomitant lesions of the surface selected for treatment, such as fractures, tendon ruptures etc; 9. Need of additional measures for the management of the traumatic lesions, such as immobilisation with plaster or other measures, surgical procedures etc; 10. Malignant disease or any other disease with life expectancy less than 2 years; 11. History of alcoholism, drug abuse, psychological or other psychiatric diseases that could invalidate informed consent or limit the subject compliance with protocol requirements; 12. Allergy, sensitivity or intolerance to study drugs and/or any of study drug formulation ingredients; 13. Pregnant or breastfeeding females, or those females not practicing adequate contraceptive measures; 14. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 15. Patients who received any investigational drug within the last 12 weeks; 16. Patients who have been previously enrolled in this study; 17. Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of heparan sulfate 1% cream and glycosaminoglycan-polysulfate gel in the relief of sum of score of subjective symptoms and objective signs of haematomas and/or subcutaneous haematic extravasations of traumatic origin.;Secondary Objective: To compare the efficacy of the two investigational medicinal products (IMPs) in the changes from baseline of individual subjective symptoms and objective signs of haematomas and subcutaneous haematic extravasations of traumatic origin; To compare the efficacy of the two IMPs in the rates of complete healing at the end of treatment; To compare the efficacy of the two IMPs in the changes from baseline of the size of the lesion; To compare the two treatment groups in terms of use of relief paracetamol; To assess the general and local safety of the two IMPs.;Primary end point(s): to compare the efficacy of heparan sulfate 1% cream and glycosaminoglycan-polysulfate gel in the relief of sum of score of subjective symptoms and objective signs of haematomas and/or subcutaneous haematic extravasations of traumatic origin. | — |
Countries
Italy
Outcome results
None listed