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GAZZETTA MEDICA ITALIANA ARCHIVIO PER LE SCIENZE MEDICHE
A Journal on Internal Medicine and Pharmacology
Indexed/Abstracted in: BIOSIS Previews, EMBASE, Scopus, Emerging Sources Citation Index
Gazzetta Medica Italiana Archivio per le Scienze Mediche 2006 October;165(5):207-19
language: English, Italian
Efficacy and safety of a new natural cream versus a classic gel in the treatment of haematoma resulting from mesotherapy or skin bio-stimulation
Pinelli S., Schianchi R., Beretta D., De Micheli P.
Istituto Dermatologico Europeo, Milan, Italy
Aim. Mesotherapy is a treatment to stimulate the repair of mesoderm, connective tissues and adipose tissue affected by cellulitis. Other aesthetic-cosmetic condition for problems such as fotoaging can be treated with skin bio-stimulation. Both mesotherapy and skin bio-stimulation could evidence haematoma on the treated areas. The aim of the study was to evaluate the efficacy and safety of a new cream formulated with natural ingredients :arnica, escina fitosoma, pineapple and bromeline (product A) versus a classic gel: rutosidea, sodium-calcium-metilgalattopoliphosphate (product B) for the reabsorption of haematoma resulting from mesotherapy or skin bio-stimulation treatments.
Methods. This was a prospective, open-label, randomized, comparative and monocenter clinical study in patients affected by panniculopathia edemato fibrosclerotica (PEFS) or fotoaging with evidence of haematoma caused by mesotherapy or skin bio-stimulation treatments. Patients were treated with product A or with product B three times daily for 12 days. Efficacy and safety were assessed after 6 days of treatment and at the end of therapy. Further-more the history of haematoma was recorded and a diary was filled out daily by each patient.
Results. Twenty-six female out patients (16 in the product group A and 10 in the product B group) were enrolled. At baseline no significant differences of mean age, kind of treatment, colour of haematoma, spontaneous pain and pain with pressure were registered. The mean size of haematoma was higher in the product B group (2.03 cm) than in the product A group (1.26 cm) while nodules were noticed in more patients (62.5%) treated with product A than in patients of the other group (40%). Haematoma was observed mainly on the face (50% and 40% in the product A and product B respectively) and on trochanteric area, internal surface of the knee, neck and ankle. Product A promoted reabsorption of haematoma and relief of pain within six days of treatment. Some improvements of haema-toma and pain were in favour of a better efficacy of product A. Haematoma dimension disappeared significantly in more patients of product A group (56.2% vs 10%) after 6 days of treatment and in the other cases the reduction in patients of the product A group was 76.6% in comparison with 58.1% in the product B group. Also the injured area cleared in more patients treated with product A (50% vs 10%) at 6 days and the difference was statistically significant. Patients of product A recovered more rapidly than the product B ones. In most part of patients (80%) discoloration of haematoma was registered within 4 days in the product A group and after 4 days in the other group. Nodules disappeared in all patients of both groups within 5 or 6 days of treatment. The relief of pain was observed within 4 or 5 days of treatment in the product A and product B groups respectively. No adverse events were noticed in any patient. Global physician’s and patient’s assessment were good in 56.2% and excellent in 43.8% of patients of product A group.
Conclusion. Product A showed good efficacy and safety and appeared to be an effective and well tolerated alternative to product B for the reabsorption of haematoma resulting from mesotherapy or skin bio-stimulation and its activity hastened the cure of the disease.