Efficacy and safety of a new medicated nail hydrolacquer in the treatment of adults with toenail onychomycosis: A randomised clinical trial.

BACKGROUND: A new water-soluble formulation with ciclopirox has shown a higher penetration than other ciclopirox nail lacquers currently marketed, thus providing a higher concentration of ciclopirox into the nail. OBJECTIVE: To evaluate the efficacy and safety of a new ciclopirox nail hydrolacquer compared with its vehicle and an active comparator (hydroxypropyl chitosan-based 80 mg/g ciclopirox nail lacquer) for the treatment of toenail fungal infection. METHODS: Phase III, multicenter, randomised, double-blind, clinical trial in patients with distal mild to moderate toenail onychomycosis due to dermatophyte fungi. Patients were randomised to apply topically a ciclopirox nail hydrolacquer, its vehicle or a reference product once daily for 48 weeks with a follow-up period of 4 weeks up to week 52. RESULTS: A total of 381 patients were included. No statistically significant differences were observed between patient groups in the proportion of subjects achieving a complete cure. At week 52, a higher percentage of patients in the ciclopirox nail hydrolacquer group achieved a mycological cure (negative for culture and DTS/KOH test, with results: 32.0% ciclopirox nail hydrolacquer, 23.2% vehicle and 27% reference product, respectively), and similar results were found for improvement (mycological cure and reduction of diseased nail ≥20%, with results: 27.2% ciclopirox nail hydrolacquer, 21.6% vehicle and 20.6% reference product, respectively). Regarding mycological results, only ciclopirox nail hydrolacquer demonstrated significant statistical superiority versus vehicle negativizing dermatophyte culture (p = .039) with no recurrences, relapses or re-infections in a four-week follow-up patients with complete cure. The safety profile was comparable to the vehicle and reference product and consistent with the previously reported. CONCLUSIONS: A new water-soluble formulation for a ciclopirox nail lacquer showed similar efficacy to the reference product to eradicate toenail onychomycosis and superiority in the mycological cure defined by negative culture, thus preventing reinfections and recurrences. Efficacy and safety data demonstrate the positive benefit-risk profile of this new topical antifungal preparation. [Correction added on 13 April 2023, after first online publication: The results and conclusions in the Abstract contained incorrect information and were revised in this version.].

Efficacy of the Treatment of Plantar Warts Using 1064 nm Laser and Cooling.

Cutaneous plantar warts may be treated using several optional methods, with the use of laser surgery having increased in the last few years. This work examined the efficacy of laser treatment combined with simple cooling to reduce pain. The cure rate was approximately 84%. There were no significant differences in the efficacy of treatment for different viral genotypes. The laser parameters were 500 msec pulses, 30 W of power, and a fluence of 212 J/cm2 delivered in up to four sessions. Successful treatment was achieved after an average of 3.6 sessions.

Evaluation of the Complementary Health Provision of the Podiatric Foot Care Program for Diabetic Patients in Catalonia (Spain).

The Catalan diabetic foot health program was established in 2009 in order to prevent complications caused by type 2 diabetes. This study aims to describe its application from 2009 to 2018. The objective was to describe diabetic foot care provision in the National Health System of Catalonia between 2009 and 2018, including the number of patients and professionals involved, the causes behind patients' visits, and the most demanded codes for diagnosis and treatment filled by the podiatrist in each consultation during 2018-2020. This description was addressed through an analysis of the database provided by the Association of Podiatrists to evaluate the implementation of the program. The results for the diabetic foot health program in Catalonia showed a growth in demand from 2009 (1726) to 2018 (213,095) in terms of visits and from 2009 (1541) to 2018 (104,629) in terms of patients. The number of registered podiatrists from 2009 to 2018 increased from 165 to 470. The most commonly used diagnosis codes were (a) without sensory alterations in control and treatment of grade 1 lesions; (b) grade 0 without neuropathic, vascular, structural, or biomechanical alteration; (c) no sensory structural alterations in the foot; (d) keratopathies. The treatments most commonly used were (a) conservative (chiropody), (b) without ortho-podiatric treatment, and (c) plantar supports. The conclusions show that the health program is in great demand amongst the population. Similarly, the coding system has made it possible to identify the diagnosis and treatment of such demand.