Open-label, controlled, randomised, single centre, parallel group clinical trial of efficacy and tolerability of Clarema 1% cream and Hirudoid 40000 U.APTT gel in the topical treatment of haematomas and subcutaneous haematic extravasations of traumatic origin - ND
- Conditions
- Patients with haematomas and subcutaneous haematic extravasations of traumatic originMedDRA version: 9.1Level: LLTClassification code 10042345Term: Subcutaneous haematoma
- Registration Number
- EUCTR2008-007829-40-IT
- Lead Sponsor
- FARMACEUTICI DAMOR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method