Peter Kurka

Efficacy of 4 weeks topical bifonazole treatment for onychomycosis after nail ablation with 40% urea: a double-blind, randomized, placebo-controlled multicenter study

Onychomycosis is a common fungal infection most often affecting the toenails. If untreated, it can cause discomfort sufficient to reduce quality of life. To evaluate efficacy and safety of bifonazole cream vs. placebo in onychomycosis treatment after non‐surgical nail ablation with urea paste. Fifty‐one study centres randomized 692 subjects with mild‐to‐moderate onychomycosis to receive bifonazole 1% cream or placebo for 4 weeks following non‐surgical nail ablation with urea 40% paste over 2–4 weeks. Efficacy of the two phase treatment was evaluated by overall cure of the target nail comprising clinical and mycological cure 2 weeks, 3 and 6 months after end of treatment. At 2 weeks (primary endpoint), overall cure rate was superior in bifonazole‐treated group (54.8% vs. 42.2% for placebo; P = 0.0024). The clinical cure rate was high in both treatment groups (86.6% bifonazole vs. 82.8% placebo), but proportion with mycological cure was higher with bifonazole treatment (64.5%) vs. placebo treatment 49.0%, (P = 0.0001). We observed higher early overall cure rate with 4 weeks topical bifonazole compared with placebo after removal of infected nail parts with urea. This two stage treatment was well tolerated and offers an additional option in topical onychomycosis therapy.

A new topical panthenol-containing emollient: Results from two randomized controlled studies assessing its skin moisturization and barrier restoration potential, and the effect on skin microflora

Abstract Purpose: Two randomized, intra-individual comparison studies were performed in healthy subjects to evaluate the skin moisturization and barrier restoration potential of a new topical panthenol-containing emollient (NTP-CE) (Study 1), and its effect on skin microflora (Study 2). Methods: In Study 1 (N = 23), two skin areas, one challenged with 0.5% sodium dodecyl sulfate (SDS) solution and one unchallenged, were treated with NTP-CE for 3 weeks. Transepidermal water loss (TEWL), skin hydration, and intercellular lipid lamellae (ICLL) organization were measured at regular intervals during the study. In Study 2 (N = 20), quantitative bacterial cultures were obtained over 6 h from a skin area undergoing wash stress with 10% SDS with subsequent single application of NTP-CE. Results: In Study 1, mean AUC for TEWL reduction from baseline was more pronounced with NTP-CE compared with control (−168.36 vs. −123.38 g/m2/h, p = 0.023). NTP-CE use was also associated with statistically significant improvements in stratum corneum hydration and an increase in mean ICLL length from baseline (day 22: 120.61 vs. 35.85 nm/1000 nm2, p < 0.001). In Study 2, NTP-CE use had no negative impact on bacterial viability. Conclusions: NTP-CE use has favorable and lasting effects on barrier function and repair as well as skin hydration without negatively influencing bacterial viability.

A new topical panthenol-containing emollient: skin-moisturizing effect following single and prolonged usage in healthy adults, and tolerability in healthy infants

Abstract Purpose: Two studies were conducted with a new topical panthenol-containing emollient (NTP-CE) to investigate the skin-moisturizing effect in healthy adults and tolerability in healthy infants. Methods: In Study 1 (N = 44), a single skin application of NTP-CE was performed followed by a 4-week twice-daily application. Skin hydration and stratum corneum (SC) water content change (using Raman spectroscopy) were measured. In the 4-week Study 2 (N = 65, aged 3–25 months), NTP-CE tolerability was assessed using a 5-point scoring system; skin hydration was determined in a subset (N = 21). Results: In Study 1, mean AUC0 − 24 h for skin capacitance change from baseline was 302.03 i.u. with NTP-CE and −15.90 i.u. in control areas (p < .001). With NTP-CE (at 4 h), the water content within the upper SC part was reduced (−45.10 vs. −13.39 g/cm2, p = .013) and the water gradient increased (0.51 vs. 0.11 g/cm4, p = .036), indicating relocation of water into deeper layers. In Study 2, there was no statistically significant change from baseline in mean cutaneous tolerability scores. At days 7, 14, and 28, skin hydration had increased by 42%, 54%, and 49%, respectively (all p < .001). Conclusions: Single and prolonged NTP-CE usage is associated with sustained and deep skin moisturization. NTP-CE is well tolerated by healthy infants.

A new topical panthenol-containing emollient for maintenance treatment of childhood atopic dermatitis: results from a multicenter prospective study

Abstract Purpose: A study was conducted with a new topical panthenol-containing emollient (NTP-CE) to investigate the efficacy and safety of a 3-month maintenance treatment in infants and children with stabilized mild atopic dermatitis (AD). Methods: After the stabilization phase (up to 2 months) using a corticosteroid-free topical medical device, 108 subjects (aged 2–49 months) with a SCORing AD (SCORAD) on the target area of <5, were randomized to receive NTP-CE (N = 52) or reference emollient (N = 56) twice-daily for ∼3 months. SCORAD scores, occurrence of flares, and tolerability were assessed at regular intervals. Results: In both groups, local SCORAD decreased during the study with a mean change from baseline (=end of stabilization phase) of −1.2 ± 1.3 (NTP-CE) and −1.0 ± 1.9. Kaplan–Meier analysis provided success rates (i.e. proportion of subjects without flares at study end) of 96 and 77% for the NTP-CE and reference group, respectively (p =.083, log-rank test). Mean time to flare-up was 47 days (range: 29–65) in the NTP CE group and 50 days (6–100). Study products were well tolerated. Conclusions: Our results indicate that NTP-CE is efficacious and safe when used for maintenance treatment of mild childhood AD.