Effect of recombinant bovine basic fibroblast growth factor gel on repair of rosacea skin lesions: A randomized, single-blind and vehicle-controlled study

The aim of the present study was to assess the effect of topical use of recombinant bovine basic fibroblast growth factor (rbFGF) gel on the repair of facial skin lesions in patients with rosacea. In the present single-blind study, a total of 1,287 patients with Demodex mite-induced rosacea who received treatment with ornidazole tablets were randomized to rbFGF gel treatment group (n=651) or control group (n=636) without revealing the group identity. Patients in the treatment group were treated with topical application of rbFGF gel over the skin lesions (0.2 g/cm(2)) for up to 8 weeks, whereas patients in the control group received gel vehicle treatment unless ulceration occurred. Skin lesions of all patients were scored prior to and following treatment with rbFGF gel and subjected to histological analysis. All patients were followed up for 6 months. Significant improvement in the total effective rates for erythema, papules, desquamation and dryness were observed in the rbFGF treatment group. At the end of the 2, 4 and 6 months of follow-up, the total effective rates for patients in the treatment group were significantly higher than those in the control group (81.67 vs. 28.84%; 85.11 vs. 40.81%, and 96.56 vs. 55.82%, respectively). Following treatment for 6 months, none of the patients in the rbFGF group exhibited ulceration or scar formation. In the control group, 61% of patients experienced exacerbation of skin lesions, of which, 12% exhibited ulceration and were treated with rbFGF gel to prevent scar formation. Histological analysis revealed gradual reduction in epidermal hyperplasia and resolution of dermal edema in skin lesions treated with rbFGF gel. In conclusion, rbFGF gel may improve the repair of facial rosacea skin lesions in patients treated with anti-Demodex.