BACKGROUND:Actinic keratoses (AKs) are frequently diagnosed in dermatological patients. As they represent in situ carcinomas, effective treatment is required. OBJECTIVES: We investigated the effect of topical 3.0% diclofenac in 2.5% hyaluronic acid gel on AK. METHODS: Sixty-five patients with AKs were clinically evaluated before and after 3 months' treatment with topical 3.0% diclofenac in 2.5% hyaluronic gel. Biopsy specimens were taken and stained with haematoxylin-eosin and immunohistological markers. Specimens were evaluated for histological type of AKs using the AK classification scheme suggested by Röwert-Huber et al. [(early) in situ squamous cell carcinoma type AK Grade I-III], number of mitoses per high-power field and expression of immunohistological markers. RESULTS:Complete clinical resolution was observed in 11 patients (16.9%). A significant (P<0.001) downgrading of AK grade was observed. Complete histological resolution was achieved in 15 patients (23.1%). The number of mitoses per high-power field was reduced significantly (P<0.001). The expression of anti-p53-antibody decreased significantly (P=0.009), as did the expression of anti-MiB-1 antibody (P=0.021). CONCLUSIONS: 3.0% diclofenac in 2.5% hyaluronic acid gel causes regression of signs of cancerous transformation after 3 months' therapy.
RCT Entities:
BACKGROUND: Actinic keratoses (AKs) are frequently diagnosed in dermatological patients. As they represent in situ carcinomas, effective treatment is required. OBJECTIVES: We investigated the effect of topical 3.0% diclofenac in 2.5% hyaluronic acid gel on AK. METHODS: Sixty-five patients with AKs were clinically evaluated before and after 3 months' treatment with topical 3.0% diclofenac in 2.5% hyaluronic gel. Biopsy specimens were taken and stained with haematoxylin-eosin and immunohistological markers. Specimens were evaluated for histological type of AKs using the AK classification scheme suggested by Röwert-Huber et al. [(early) in situ squamous cell carcinoma type AK Grade I-III], number of mitoses per high-power field and expression of immunohistological markers. RESULTS: Complete clinical resolution was observed in 11 patients (16.9%). A significant (P<0.001) downgrading of AK grade was observed. Complete histological resolution was achieved in 15 patients (23.1%). The number of mitoses per high-power field was reduced significantly (P<0.001). The expression of anti-p53-antibody decreased significantly (P=0.009), as did the expression of anti-MiB-1 antibody (P=0.021). CONCLUSIONS: 3.0% diclofenac in 2.5% hyaluronic acid gel causes regression of signs of cancerous transformation after 3 months' therapy.