THE TOPICAL APPLICATION OF VITAMIN E GEL REDUCES THE TIME OF HEALING IN DIGITAL ULCERS OF HANDS IN SYSTEMIC SCLEROSIS (SSC) PATIENTS

Background: Vitamin E (Vit.E) comprehends a group of liposoluble molecules (tocopherols and alpha-tocotrienols) with anti-oxidative, vasodilating and anti-aggregating properties. In SSc patients, the digital ulcers of the hands, mainly caused by microvessel changes, heavily affect the quality of life because painful, difficult to heal, and easy to be infected. Since years, Vit.E has been used with good results on skin lesions of autoimmune diseases such as SSc, discoid lupus erythematosus, vasculitides, dermatomyositis. Objectives: To study the effects of a gel of topic D-alpha-tocopheryl acetate (acetic ester of alpha-tocopherol), compared to the standard topic treatment used in our Department, on digital hand ulcers of SSc patients in terms of reduction of pain, healing time and number of medications. Methods: 27 SSc patients with a total of 87 digital ulcers at fingers (mean diameter: 0.9 cm ± 0.2 SD; range: 0.5-1.5 cm; duration 3-18 months; number of ulcers/patient: 3.22±1.65), classified at stage 3 (90%) and 4 (10%), according to the classification of cutaneous lesions of the National Pressure Ulcer Advisory Panel (1), were enrolled. The patients were all assuming the same systemic drugs (proton pump inhibitors, prokinetics, and intravenous weekly infusions of Alprostadil). 15 patients (total number of ulcers: 52; number of ulcers/patients: 3.46±1.72) were treated with the standard topic protocol used in our Department for SSc ulcers plus D-alpha- tocopheryl acetate gel (Group 1) and 12 patients (total number of ulcers: 35; number of ulcers/patients: 2.92±1.61) were treated only with our standard topic protocol (Group 2). In Group 1, ulcers were medicated twice a week as following: 1) Cleansing with physiologic solution; 2) disinfection by Sodium Hypochlorite (chlorine) 5% for few seconds and rinsing with physiologic solution; 3) surgery curettage if an eschar was present; 4) Application of D-alpha- tocopheryl acetate 96% gel on the lesion; 5) application of "hydrogel" and covering with a paraffin gauze; 6) closing of the medication. In group 2, the procedure was the same, except for the absence of application of D-alpha- tocopheryl acetate gel. At the enrolment and at each medication, the patients were given a pain VAS (visuoanalogic scale), with 0 as "no pain" and 10 as "maximum of pain") for pain evaluation. Results: In Group 1, the application of D-alpha- tocopheryl acetate gel did not cause local or systemic side effects and induced a faster resolution of pain in respect to Group 2 (1.2±0.8 applications versus 2.5±1.8 applications; p< 0.05) The digital ulcers of Group 1 healed in 12.79±4.1 weeks, while those of group 2 healed in 21.0±3.2 weeks (p< 0.05). Accordingly, the number of medications needed for ulcer healing was 25.58±8.0 in Group 1 versus 42.0±6.3 of Group 2 (p<0.05). Conclusion: The topical application of D-alpha- tocopheryl acetate gel on digital ulcers of SSc patients is safe. It leads to resolution of pain and to ulcer healing in almost half of the time in respect to the standard topical treatments. The reduction of medications also improves the management of SSc patient and reduces the direct and indirect costs of ulcer care. Thus, D-alpha- tocopheryl acetate, can be regarded as a new useful tool in the treatment of SSc ulcers.