A randomized half-body, double blind, controlled trial on the effects of a pH-modified moisturizer vs. standard moisturizer in mild to moderate atopic dermatitis,

Abstract Background: Higher skin pH in atopic dermatitis contributes to impaired epidermal barrier. A moisturizer compatible with physiological pH could improve atopic dermatitis. Objective: To determine the effect of a physiologically compatible pH moisturizer in atopic dermatitis. Methods: A randomized half body, double blind, controlled trial involving patients with stable atopic dermatitis was performed. pH-modified moisturizer and standard moisturizer were applied to half body for 6 weeks. Results: A total of 6 (16.7%) males and 30 (83.3%) females participated. Skin pH reductions from week 0, week 2 and 6 were significant at the forearms (5.315 [0.98] to 4.85 [0.54] to 5.04 [0.78], p = 0.02) and abdomen (5.25 [1.01], 4.82 [0.64], 5.01 [0.59], p = 0.00) but not at the shins (5.01 [0.80], 4.76 [0.49], 4.85 [0.79], p = 0.09) with pH-modified moisturizer. Transepidermal water loss (TEWL) at the forearms decreased (4.60 [2.55] to 3.70 [3.10] to 3.00 [3.55], p = 0.00), abdomen (3.90 [2.90] to 2.40 [3.45] to 2.70 [2.25], p = 0.046). SCORAD improved from 14.1 ± 12.75 to 10.5 ± 13.25 to 7 ± 12.25, p = 0.00. In standard moisturizer group, pH reductions were significant at the forearms (5.29 [0.94] to 4.84 [0.55] to 5.02 [0.70], p = 0.00) and abdomen (5.25 [1.09], 4.91 [0.63], 5.12 [0.66], p = 0.00). TEWL at the forearm were (4.80 [2.95], 4.10 [2.15], 4.60 [3.40], p = 0.67), shins (3.80 [1.40], 3.50 [2.35], 4.00 [2.50], p = 0.91) and abdomen (3.70 [2.45], 4.10 [3.60], 3.40 [2.95], p = 0.80). SCORAD improved from 14.2 ± 9.1 to 10.9 ± 10.65 to 10.5 ± 11, p = 0.00. Reduction in pH was observed with both moisturizers while TEWL significantly improved with pH-modified moisturizer. pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer. Study limitation: Skin hydration was not evaluated. Conclusion: Moisturization is beneficial for atopic dermatitis; use of physiologically compatible pH moisturizer is promising.

Effects of a mucoadhesive formulation containing Curcuma longa L. on oral wound healing

Introduction: The aim of this study was to investigate the effects of a topical mucoadhesive formulation with Curcuma longa L. extract (MFC) on oral wound healing. Methods: Seventy-two Wistar rats were randomly assigned to 3 groups: Control, Vehicle, and MFC. Traumatic ulcers were made on the dorsum of the tongue with a 3-mm diameter punch. Vehicle and MFC groups received application of the products twice a day, while animals in the control group were cared for in identical conditions but received no product application. Six rats in each group were euthanized at days 3, 5, 10, and 14. Percentage of repair was calculated based on wound area. HE-stained histological sections were obtained for semi-quantitative analysis of re-epithelization and inflammation. Results: Clinical findings revealed that at days 3 and 5, animals from the MFC group exhibited a significantly higher percentage of wound repair. At day 5, animals from this group also demonstrated a significant increase in the degree of re-epithelization and inflammation. Conclusions: MFC is capable of accelerating oral wound repair in an in vivo model by modulating the inflammatory process and stimulating epithelial proliferation. (AU)

Estabilidad de la crema reformulada de nitrato de miconazol al 2 % / Stability of reformulated 2 % miconazol nitrate cream

INTRODUCCIÓN: la Empresa Productora Roberto Escudero Díaz, llevó a cabo la reformulación de la crema de nitrato de miconazol al 2 por ciento, por incumplimiento de algunas especificaciones de calidad y contaminaciones microbiológicas de varios lotes industriales, por lo que hubo que realizar cambios mayores a la composición de la formulación registrada. OBJETIVO: determinar la estabilidad de la nueva formulación de nitrato de miconazol crema al 2 por ciento, para determinar su período de validez. MÉTODOS: se realizaron los estudios según las regulaciones vigentes. Se emplearon tres lotes elaborados a escala piloto, envasados en tubos comprimibles de aluminio por 25 g. Se emplearon como métodos analíticos una técnica por cromatografía líquida de alta resolución y una por cromatografía en capa delgada previamente validadas para estos propósitos. Se consideraron dos temperaturas de almacenamiento: 30 ± 2 ºC (vida de estante) y 40 ± 2 ºC (estabilidad acelerada). Se determinaron los parámetros: propiedades organolépticas, pH, área de extensibilidad, valoración, contenido de sustancias relacionadas y/o productos de degradación, y además se evaluó la calidad de la formulación desde el punto de vista microbiológico. RESULTADOS: desde el punto de vista químico, los lotes evaluados mostraron contenidos superiores al 98 por ciento de analito y niveles muy bajos de sustancias relacionadas, independientemente del lote y la temperatura de almacenamiento. No se detectaron manchas adicionales por cromatografía en capa delgada atribuibles a posibles productos de degradación. La extensibilidad mostró un decrecimiento normal debido a la estructuración progresiva del sistema, y el pH también disminuyó discretamente pero dentro de los límites propuestos. Además se comprobó la elevada estabilidad microbiológica del medicamento a los 12 meses. CONCLUSIONES: la crema es estable química, física y microbiológicamente a temperatura ambiente durante 12 meses, por lo que se propone este tiempo como período de validez provisional(AU)

INTRODUCTION: Roberto Escudero Diaz drug producing company is carrying out the reformulation of 2 percent miconazole nitrate cream due to non-compliance with some quality specifications and the microbiological contamination of several industrial batches, so it was required to make major changes in the registered formulation composition. OBJECTIVE: to determine the stability of the new 2 percent miconazol nitrate cream formulation to verify its validity period. METHODS: the studies followed the regulations in force. Three pilot-scaled batches, packed in 25 g aluminum tubes, were used. The analytical methods were high resolution liquid chromatography technique and thin layer chromatography, being both methods previously validated for these purposes. The selected storage temperatures were 30 ± 2 °C (shelf life) and 40 ± 2 ºC (accelerated stability). The estimated parameters included organoleptic properties, pH, extensibility area, titration, content of related substances and/or degradation products in addition to evaluating the quality of formulation from the microbiological viewpoint. RESULTS: from the chemical viewpoint, the evaluated batches showed contents over 98 percent of analyte and very low levels of related substances, regardless of batch and the storage temperature. The thin layer chromatography did not detect any additional stain attributed to possible degradation products. The extensibility showed normal decrease resulting from progressive structuring of the system and the pH also lowered within the set limits. The microbiological stability of the drug was proved to be high after 12 months. CONCLUSIONS: the cream was chemically, physically and microbiologically stable at room temperature for 12 months, so this is the term suggested as the temporary validity period(AU