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A Journal on Physiopathology and Therapy of Chronic Cutaneous Ulcers

Official Journal of the Italian Association for Cutaneous Ulcers
Indexed/Abstracted in: EMBASE, Scopus, Emerging Sources Citation Index

Frequency: Quarterly

ISSN 1721-2596

Online ISSN 1827-1774


Acta Vulnologica 2009 March;7(1):31-8


A new medical preparation for the treatment of skin lesions

Lualdi P. 1, Berzovini C. 2, Emanuelli G. 3, Fiori F. 4, Garibba R. 5, Germiglio C. 6, Ghezzi M. 7, Longobardi P. 8, Marletta S. 9, Mascaro A. 10, Mongiardino V. 11, Montanaro V. 12, Morisi C. 13, Mosca L. 14, Nicolardi M. M. 15, Panzone M. 16, Perrone C. 17, Pibiri L. 18, Regazzini R. 19, Rodano L. 20, Rusignolo F. 21, Sabatino V. 22, Serra C. 23, Stamerra V. 24, Torre C. 25

1 Erba, Como, Italia
2 Torino, Italia
3 Chirurgia Vascolare II, Monza, Milano, Italia
4 Nerviano, Milano, Italia
5 Presidio Ospedaliero L. Bonomo, Ambulatorio di Chirurgia Plastica, Andria, Bari, Italia
6 Azienda Ospedaliera Umberto I, Chirurgia Vascolare, Siracusa, Italia
7 Clinica S. Siro, Milano, Italia
8 Centro Iperbarico S.r.l., Ravenna, Italia
9 Ospedale Ferrarotto, Chirurgia Vascolare, Catania, Italia
10 Solignano di Castelvetro, Modena, Italia
11 Torino, Italia
12 Locorotondo, Bari, Italia
13 Ospedale Civile S. Maria delle Croci
Ravenna, Italia
14 Grottaglie, Taranto, Italia
15 Spongano, Lecce, Italia
16 Vinovo, Torino, Italia
17 Ospedale “V. Fazzi”, Lecce, Italia
18 Azienda Ospedaliera Brutzu, Cagliari, Italia
19 Milano, Italia
20 Fondazione San Raffaele Cittadella della Carità Taranto, Italia
21 Azienda Ospedaliera Universitaria
Policlinico P. Giaccone, Palermo, Italia
22 S. Paolo Belsito, Napoli, Italia
23 Ospedale S. Martino, Oristano, Italia
24 Azienda USL LE/2, Distr. n. 1 di Gallipoli Casa di Riposo e Protetta “S. Rita”, Alezio Lecce, Italia
25 ASL 6 Rep. Geriatria, Palermo, Italia

Aim. To collect information on the efficacy and tolerability of Skincol® gel in the treatment vascular ulcers.
Methods. In this multicenter, non-controlled, observational phase IV study involving patients with venous stasis ulcers or other skin lesions, Skincol® gel was applied once daily for a maximum of 90 days. At control visits every 15 days, patients were assessed for: lesion extension; improvement in symptoms (inflammation, exudate, swelling, pain, burning); granulation tissue; healing time; judgement of product efficacy, tolerability and acceptability; ease of use and comparison with habitual therapies; type and severity of adverse events.
Results. Of 363 patients recruited, 353 (83.5% with vascular ulcers; 5.7% with diabetic ulcers; 8.5% with decubitus sores; 2.3% with burns or other skin wounds) received treatment with Skincol® gel. Of these 353 patients, final efficacy assessment was carried out on 344 patients. Lesion extension gradually decreased (global improvement P=0.0001; improvement at 15-day assessment over baseline P<0.05); granulation tissue formed (global improvement P=0.0006; improvement at 15-day assessment over baseline P<0.05); and symptoms improved (global improvement P=0.0019; improvement at 15-day assessment over baseline P<0.05); clinical healing was noted in 269 (78.2%) patients within 59.29±21.64 days. Clinical efficacy was judged as good to very good in 77% of cases; product acceptability and ease of use were judged as good to very good in 80.7% and 92.5% of cases, respectively; Skincol® gel was found to be better than habitual therapies in 67.9% of cases, equally good in 26.0%, and inferior in 6.0%. Product tolerability was judged good to very good in 83.7% of cases. During the study period, 11 (3.12%) adverse events occurred, 3 of which were local hypersensitivity reactions that led to suspension of treatment.
Conclusions. Within the limitations of an observational study such as this, the study product was found to be efficacious and well tolerated in the treatment of skin lesions of various origin.

language: Italian


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