Efficacy and Safety of Nicotinamide 10%, Associated with Magnesium Ascorbyl Phosphate 5% and Hyaluronic Acid 5%, Compared to Hydroquinone 4% in Women with Facial Melasma: A Randomized, Double-Blind, Controlled Clinical Trial.

Mayla Barbosa,1 Rebecca Perez de Amorim,1 Daniel Cassiano,2 Marina Dias,1 Ana Flávia de Abreu,1 Edileia Bagatin,2 Hélio Amante Miot,1 Ana Cláudia Cavalcante Espósito1 1Department of Dermatology, Faculdade de Medicina de Botucatu (UNESP), Botucatu, SP, Brazil; 2Department of Dermatology, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, BrazilCorrespondence: Ana Cláudia Cavalcante Espósito, Department of Dermatology, Faculdade de Medicina de Botucatu, UNESP Medical School, Botucatu, SP, Brazil, Email [email protected]: Nicotinamide has demonstrated efficacy in the treatment of melasma. Topical antioxidants and humectants may enhance its performance. Currently, there is no controlled trial on the combination of 10% nicotinamide, 5% magnesium ascorbyl phosphate, and 5% hyaluronic acid, a dermo-cosmetic compound, in comparison to 4% hydroquinone for the treatment of melasma. This study aimed to explore the tolerability and efficacy of the association of the combined product versus hydroquinone.Methods: A randomized, double-blind trial involving women with facial melasma was conducted. Participants were instructed to apply the combined product (NIC group) twice daily or 4% hydroquinone for 60 days (HQ group) at night and placebo in the morning. Evaluations were performed at inclusion, after 14 and 60 days of treatment, measuring the modified Melasma Area and Severity Index (mMASI), Melasma Quality of Life Scale (MELASQoL), and colorimetric luminosity. The Global Aesthetic Improvement Scale (GAIS) was assessed by a blinded evaluator.Results: Both interventions led to a progressive improvement in mMASI, MELASQoL, and GAIS, without a difference between them on D14 and D60 (p> 0.2). For NIC, the mean reduction (95% CI) in mMASI was 16% (8– 24%) on D14 and 32% (23– 41%) on D60, while for HQ, it was 10% (7– 24%) on D14 and 43% (34– 52%) on D60. Reduction in colorimetric luminosity was greater in the HQ group at D60 (p=0.01). No serious side effects were identified. Of the initially included 50 patients, one was lost to follow-up in the HQ group on D60, and one withdrew consent from the NIC group, both unrelated to treatment.Conclusion: The association of 10% nicotinamide, 5% magnesium ascorbyl phosphate, and 5% hyaluronic acid was safe and well-tolerated, although its overall clinical efficacy was numerically inferior to 4% hydroquinone. This regimen can be considered for patients with poor tolerability to hydroquinone.Clinical Trial Registration: #RBR-4mkfmr8.Keywords: melasma, hyperpigmentation, nicotinamide, hydroquinone, antioxidant

The effects of a muscle resistance program on the functional capacity, knee extensor muscle strength and plasma levels of IL-6 and TNF-α in pre-frail elderly women: a randomized crossover clinical trial - a study protocol

<p>Abstract</p> <p>Background</p> <p>With the increase in the elderly population, a growing number of chronic degenerative diseases and a greater dependency on caregivers have been observed. Elderly persons in states of frailty remain more susceptible to significant health complications. There is evidence of an inverse relationship between plasma levels of inflammatory mediators and levels of functionality and muscle strength, suggesting that muscle-strengthening measures can aid in inflammatory conditions. The purpose of this study will be verified the effect of a muscle-strengthening program with load during a ten-week period in pre-frail elderly women with attention to the following outcomes: (1) plasma levels of interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-α), (2) functional capacity and (3) knee extensor muscle strength.</p> <p>Methods/Design</p> <p>The study design is a randomized crossover clinical trial evaluating 26 elderly women (regardless of their race and/or social condition) who are community residents, older than 65, and classified as pre-frail according to the criteria previously described by Fried et al. (2004). All subjects will be assessed using the Timed up and go and 10-Meter Walk Test functional tests. The plasma levels of IL-6 and TNF-α will be assessed by ELISA (<it>enzyme-linked immunosorbent assay</it>) with high sensitivity kits (Quantikine^®HS, R&D Systems Minneapolis, MN, U.S.). Knee extensor muscle strength will be assessed using the <it>Byodex System 3 Pro</it>^{<it>® </it>}isokinetic dynamometer at angular speeds of 60 and 180°/s. The intervention will consist of strengthening exercises of the lower extremities at 50 to 70% of 1RM (maximal resistance) three times per week for ten weeks. The volunteers will be randomized into two groups: group E, the intervention group, and group C, the control group that did not initiate any new activities during the initial study period (ten weeks). After the initial period, group C will begin the intervention and group E will maintain everyday activities without exercising. At the end of the total study period, all volunteers will be reassessed.</p> <p>Discussion</p> <p>To demonstrate and discuss possible influences of load-bearing exercises on the modification of plasma levels of IL-6 and TNF-α and in the functional performance of pre-frail elderly women.</p> <p>Trial Registration</p> <p>ISRCTN62824599</p

Evaluation of digital educational studenttechnology interaction in neonatal nursing

OBJECTIVE To assess the digital educational technology interface Caring for the sensory environment in the neonatal unit: noise, lighting and handling based on ergonomic criteria. METHODS Descriptive study, in which we used the guidelines and ergonomic criteria established by ISO 9241-11 and an online Likert scale instrument to identify problems and interface qualities. The instrument was built based on Ergolist, which follows the criteria of ISO 9141-11. There were 58 undergraduate study participants from the School of Nursing of Ribeirao Preto, University of Sao Paulo, who attended the classes about neonatal nursing content. RESULTS All items were positively evaluated by more than 70% of the sample. CONCLUSION Educational technology is appropriate according to the ergonomic criteria and can be made available for teaching nursing students

Influence of extracts of Stryphnodendron polyphyllum Mart. and Stryphnodendron obovatum Benth. on the cicatrisation of cutaneous wounds in rats

Stem bark of the two species Stryphnodendron polyphyllum Mart. and Stryphnodendron obovatum Benth., Leguminosae, was investigated for wound healing, antibacterial and antioxidant activity. These plants contain 12 and 19% tannins in their stem bark, respectively, and are widely used in traditional medicine in Brazil. The total content of phenolics of the crude extract (CE) of Stryphnodendron obovatum was 76.95 +/- 2.98% (CV = 3.87%) and of the ethyl-acetate fraction (EAF) was 89.13 +/- 0.34% (CV = 0.38%); whereas in Stryphnodendron polyphyllum the CE phenolics content was 51.62 +/- 1.53% (CV = 2.96%) and the EAF phenolics content was 59.00 +/- 1.91% (CV = 3.24%). The tannin content of CE from Stryphnodendron obovatum [36.58 +/- 0.35% (CV = 0.98%)] was about 11% higher than in CE from Stryphnodendron polyphyllum [25.43 +/- 0.96% (CV = 3.77%)]. The difference between the species was even greater in the EAF: in Stryphnodendron obovatum the EAF phenolics content was 55.01 +/- 0.36% (CV = 0.65%), whereas in Stryphnodendron polyphyllum the content was 36.16 +/- 0.42% (CV = 1.16%). The healing effect of ointments containing 2.5% crude lyophilised extract (PCE) and 2.5% ethyl-acetate lyophilised fraction (PEA) of the stem bark of Stryphnodendron polyphyllum and Stryphnodendron obovatum was studied in cutaneous wounds of Wistar((R)) rats after 4, 7 and 10 days of treatment. Epithelial cell proliferation in the area of re-epithelialisation of the wounds was evaluated by counting the metaphases blocked by vincristine sulfate. With PCE an increase in epidermal growth was observed after 4 and 7 days of treatment with Stryphnodendron polyphyllum, and after 7 and 10 days of treatment with Stryphnodendron obovatum. Wounds treated with PEA of Stryphnodendron obovatum showed increased epidermal growth only 4 days after the treatment, for Stryphnodendron polyphyllum, epidermal growth was observed after 4 and 7 days of treatment. Both the CE and the EAF fractions of Stryphnodendron polyphyllum and Stryphnodendron obovatum showed antibacterial activity against Staphylococcus aureus with MIC values of 125 and 250 mu g/ml, respectively. Gram-negative bacteria tested were not inhibited by extracts and fractions at concentrations > 1000 mu g/ml. The antioxidant activity through reduction of the DPPH radical in TLC, confirmed the anti-radical properties of these extracts in both species. CE and EAF of both species showed a radical scavenging activity (RSA) and protected DPPH from discolouration, already at 0.032 mu g/ml. The extract from Stryphnodendron polyphyllum were more effective than those Stryphnodendron obovatum, although the former had a lower tannin content. (c) 2005 Elsevier B.V.. All rights reserved