Efficacy and Safety of Naftifine Hydrochloride 2% Gel in Interdigital Tinea Pedis: A Phase III Randomised, Double-Blind, Parallel-Group, Active-Controlled Study in Indian Adult Patients.

BACKGROUND AND OBJECTIVE: Naftifine, an allylamine, is highly effective against tinea pedis and exhibits relatively greater affinity to skin and nail beds, possibly due to its high lipophilicity. To study the efficacy and safety of naftifine 2% gel in an Indian population, a phase III multicentre double-blind, comparative, parallel-group study was conducted in comparison with miconazole 2% gel in patients with interdigital tinea pedis, with mild to moderate symptoms. PATIENTS AND METHODS: Patients presenting with mild to moderate signs and symptoms of interdigital tinea pedis and mycologically confirmed tinea infection were randomised to either naftifine hydrochloride 2% gel (n = 112) or miconazole 2% gel (n = 112) in 1:1 ratio. All patients were treated for 2 weeks with a follow-up of up to 12 weeks. Study evaluations were done at the end of 2, 6, and 12 weeks. The primary efficacy endpoint was the proportion of patients achieving clinical cure at week 6 (± 4 days) and secondary endpoints were the mycological cure at week 6 and week 12 and complete cure at week 12. RESULTS: At the end of week 6, clinical cure was 54.55% and 50.00% in the naftifine and miconazole groups (p = 0.4960), respectively, and it was increased to 78.18% and 76.36% in the naftifine and miconazole group (p = 0.7455) at the end of week 12. Mycological and clinical cure were similar in the naftifine and miconazole groups at week 6 and week 12. The safety and tolerability profiles of both treatments were similar. CONCLUSIONS: Naftifine 2% gel was efficacious and safe for the treatment of mild to moderate interdigital tinea pedis. Its clinical effectiveness was comparable to that of miconazole 2% gel. TRIAL REGISTRATION: Clinical Trials Registry of India: CTRI/2021/01/030753.

Dermatological Manifestations in Patients Undergoing In Vitro Fertilisation: A Prospective Study.

BACKGROUND: Changing sociodemographic patterns with an increase in the age of childbirth have affected fertility rates worldwide. With advancing reproductive medicine, assisted reproductive techniques (ARTs) are becoming common. While dermatological manifestations in normal pregnancies have been well documented, there is a paucity of data regarding cutaneous manifestations in patients undergoing ART. OBJECTIVES: The objectives of our study were to estimate the incidence and types of dermatological manifestations in patients undergoing in vitro fertilisation (IVF) and to study their associations with age, type of infertility, and outcome of the procedure. METHODS: A prospective cohort of 200 patients undergoing IVF in a tertiary care centre was observed for occurrence of any dermatological manifestations from initiation of the IVF protocol to the outcome of the procedure at 3 weeks after embryo transfer. RESULTS: Dermatological manifestations were seen in 27% of the study group, with urticaria being the most common cutaneous finding seen in 13.5%, followed by acneform eruptions (3%). Twenty-six (96.3%) of patients who manifested with urticaria were on progesterone. No statistically significant association was found between the occurrence of dermatological manifestations and the outcome of IVF, type of infertility, history of ART, and ovum donation in our study. Association between the age of the patient and the outcome of IVF cycle was statistically significant. CONCLUSION: Dermatological manifestations are seen in almost one-quarter of patients undergoing IVF, with progesterone-induced urticaria being the most common. Occurrence of cutaneous manifestations has no significant association with the outcome of IVF.