A multicentre, open, investigator-initiated phase IV clinical trial to evaluate the efficacy and safety of ingenol mebutate gel, 0·015% on the face and scalp, and 0·05% on the trunk and extremities, in Korean patients with actinic keratosis (PERFECT).

BACKGROUND: Ingenol mebutate gel is a novel, field-directed topical treatment for actinic keratosis (AK). Most pivotal studies have targeted Western populations. No clinical study has been conducted to investigate its efficacy and safety in Asian populations. OBJECTIVES: To evaluate the efficacy and safety of ingenol mebutate gel for treating AK of face/scalp and trunk/extremities in a large Asian (Korean) population. PATIENTS AND METHODS: In this multicentre, open-label, interventional, parallel-group, prospective phase IV study (PERFECT, trial registration no.: NCT02716714), the eligible patients were allocated into either the face/scalp or the trunk/extremities group, according to their selected treatment area location. After application of ingenol mebutate gel, the participants were followed up for 6 months. The primary efficacy endpoint was complete clearance (CC) of AK lesions in the selected treatment area at day 57. Quality of life was evaluated using Skindex-29. Safety endpoints included local skin responses, scar, pigmentation, pain and adverse events. RESULTS: In total, 78·1% [95% confidence interval (CI) 66·86-86·92%] of subjects had CC at day 57, with 76·6% (95% CI 64·31-86·25%) in the face/scalp group and 88·9% (95% CI 51·75-99·72%) in the trunk/extremities group. Among them, CC was sustained in 88·9% (48 of 54, 95% CI 77·37-95·81%) at month 6. The local skin responses significantly increased 1 day after the treatment compared with baseline, and decreased afterwards. Among the total subjects, 7·8% (6 of 77) had hyperpigmentation on the application area. Scars were not reported. CONCLUSIONS: Ingenol mebutate is effective for the treatment of AK in Asians, with tolerable safety profiles.

The relationship between quality of life and the severity of psoriasis in Turkey.

BACKGROUND: Patients with psoriasis experience a low quality of life and high treatment burden: OBJECTIVES: To assess psoriatic patient quality of life using the Dermatology Life Quality Index (DLQI) in the Northeastern Anatolia region of Turkey. Additionally, we evaluated the correlation between the DLQI and the clinical severity of psoriasis and examined demographic data and their relationship with the DLQI and psoriasis severity: MATERIALS AND METHODS: This study was a single-center, prospective, cross-sectional study at the University of Kafkas, Kars, Turkey. 127 adult patients were included in the study. The Turkish version of the DLQI was used. To measure psoriasis severity, the Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) were simultaneously evaluated. The patient demographics were compared with quality of life and the severity of psoriasis: RESULTS: DLQI scores ranged from "very large" to "extremely large" in 61% of the patients. The psoriasis severity (BSA and PASI) was "mild" in 63% of patients. The quality of life was significantly affected in cigarette smokers and in patients whose disease included nail involvement. The PASI and BSA scores of patients with scalp and nail involvement were significantly higher. A significant, positive correlation was found between disease duration and the severity of psoriasis. BSA correlated with PASI: CONCLUSION: The quality of life of psoriasis patients is strongly reduced. A significant relationship was found for DLQI with nail psoriasis and smoking. A linear, positive correlation was detected between the DLQI and BSA but not between the DLQI and PASI.

Quality of life in patients with scalp psoriasis.

AIM: The aims of this study were to describe the quality of life (QoL) in patients suffering of scalp psoriasis and to assess the impact of the socio-demographic and clinical features of this condition on patients' health-related QoL, using general and specific QoL scales. METHODS: This research is a cross-sectional study. The study involved 55 patients attending their first examination at the Dermatology Clinic of Padua University over the course of one year (April 2010-March 2011). The outcome was quality of life analyzed by means Scalpdex and SF-36 questionnaire. RESULTS: The sample's mean Scalpdex score was 43.60±17.52, while the mean SF-36 score was 68.28±20.32. The SF-36 identified statistically significant differences between the psoriasis patients and the Italian general population in two domains, i.e. general health (P=0.0075) and emotional role (P=0.0048). The severity of patients' scalp lesions emerged as a factor associated with a reduced QoL in these patients, irrespective of the severity of their disease as a whole. Sex, age, schooling and other socio-demographic factors also characterized patients' perceived QoL. CONCLUSION: Patients with scalp psoriasis suffered from a lower QoL relating to the highly visible site of their psoriatic lesions. Specific supportive measures should be dedicated to these patients by health care workers.

Podophyllin reaction mimicking Bowen's disease in a patient with delusions of verrucosis.

A 40-year-old woman presented with a delusion of warts on the forehead, for which she was applying podophyllin toxin. A skin biopsy was taken, which showed prominent mitotic figures in the basal and suprabasal layers of the epidermis and apoptotic keratinocytes. Histopathologically Bowen's disease was suspected, but was discounted after clinicopathological correlation was obtained and showed absence of epidermal atypia or disorganization. This case demonstrates the histological resemblance of podophyllin reaction to Bowen's disease. Differentiation of self-inflicted from organic skin disease may be difficult, especially where histopathological findings are confounded by cutaneous application of toxins.