Clinical, biometric and ultrasound assessment of the effects of daily use of a nutraceutical composed of lycopene, acerola extract, grape seed extract and Biomarine Complex in photoaged human skin

Costa, Adilson; Lindmark, Lars; Arruda, Lúcia Valéria Ramos de; Assumpção, Elvira Cancio; Ota, Fernanda Sayuri; Pereira, Margareth de Oliveira; Langen, Stéphanie Selma Barros

doi:10.1590/s0365-05962012000100006

Cited by 23 publications

(30 citation statements)

References 21 publications

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“…It is highly recommended that the same phenomenon be assessed at different endpoints. 21 Correlation between the results of each endpoint reinforces the trustworthiness of the effect. Confounders should be carefully considered and also assessed for later adjustment of their effects.…”

Section: Efficacy and Safety Measuresmentioning

confidence: 76%

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How to design and write a clinical research protocol in Cosmetic Dermatology*

Bagatin

Miot

2013

An. Bras. Dermatol.

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Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment.

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Section: Efficacy and Safety Measuresmentioning

confidence: 76%

“…19 Open studies and those with associated interventions in just one group of subjects can report positive conclusions, but they have limited value for Evidence-based medicine. 20,21 …”

Section: Designmentioning

confidence: 99%

How to design and write a clinical research protocol in Cosmetic Dermatology*

Bagatin

Miot

2013

An. Bras. Dermatol.

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“…The same is true for echogenicity measurements: increased overall echogenicity [29,32,38,39], decreased overall echogenicity [40], increased echogenicity of the upper dermis [41] and increased echogenicity of the lower dermis [31] and decreased LEP ratio between the upper and lower dermis [42]. Studies heterogeneity may reflect the absence of a consensus or a guideline standardizing the US measurements that must be done and the changes that are most probably related to effectiveness and clinical outcome.…”

Section: Applications Of Us Imaging In Dermatologic Researchmentioning

confidence: 99%

“…This is of particular concern because some trials have employed US evaluation alone, without any other improvement measurements [29,31,33]. In contrast, studies that evaluated clinical, histological and sonographic end-points have shown that changes in US findings occur together with clinical [32, [36][37][38]42] and histological improvement [34,39]. Nevertheless, future investigations are still required to validate studies' results and prove that US can be used as a quantitative tool to assess skin changes alone [32].…”

Section: Applications Of Us Imaging In Dermatologic Researchmentioning

confidence: 99%

Ultrasound and dermatology: basic principles and main applications in dermatologic research

Bagatin

Caetano

Soares

2013

Expert Review of Dermatology

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Ultrasound imaging has been increasingly used in dermatologic research over the past four decades. This paper aims to review its use as a disease severity and treatment efficacy assessment tool, with emphasis on the past five years. Quantitative parameters such as skin thickness, overall echogenicity, echogenicity distribution, dermal-subcutaneous interface length or area are used. The authors review skin aging, cellulite, striae, fillers, scleroderma, hypertrophic scar, wounds and psoriasis studies, and discuss correlation between sonographic findings and clinical assessment and/or validated scores. Data are still insufficient to support ultrasound imaging use as an unique efficacy assessment method in a trial, but favor that it is a valuable adjuvant assessment tool that brings objectiveness to subjective clinical assessment. Further studies and technology improvement will expand its applications in dermatology. KEYWORDS: dermatology • lipodystrophy • localized scleroderma • psoriasis • scars • skin aging • systemic scleroderma • ultrasonography • ultrasound biomicroscopy • wound healingUltrasonography has been used in medicine for more than 50 years and is one of the most frequently applied diagnostic tools. It is a noninvasive and non-ionizing method with a relatively low cost when compared with computed tomography and scintigraphic scanning techniques [1]. Alexander and Miller were the pioneers in the use of ultrasound (US) in dermatology since 1979 [2]. They demonstrated a15 MHz one-dimensional (A-scan) US equipment that measured the skin thickness with similar accuracy to the radiological techniquethe most accurate non-invasive method so far. Three years later its reproducibility and validation was shown, although the skin thickness determined in vitro was found to be greater than when in vivo determinations were made, probably due to the release of in vivo tension within the dermis [3].The 20 MHz bidimensional (B-scan) US units were first available in the 1980s, thanks to the emergence of mechanical transducers that enabled the cross-sectional imaging of the skin [4]. From then on, studies have evaluated its application in a range of skin conditions with different aims: disease severity and treatment response evaluation, adjunct diagnostic tool, tumor dimensions assessment and other uses. This paper reviews the state of art of US imaging in dermatologic research, focusing on its role as a disease severity and/or treatment efficacy assessment tool, with emphasis on the most frequently reported applications over the past five years. The use of US as a diagnostic tool or for tumor dimension assessment is not discussed here. ConceptsUS is a mechanically propagated wave with frequency above 20 kHz -the upper frequency limit of human hearing [5]. US transducers are made out of piezoelectric materials that generate acoustic energy when a voltage is applied to them. The US beam is transferred as a pulse from the transducer to the adjacent fluid or tissue and propagates as a wave, which can be reflected or refract...

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“…It is mostly used for the evaluation of skin tumor thickness (e.g., basal cell carcinoma, melanoma). Other areas of application include scleroderma, striae distensae, psoriasis, and aged and photoaged skin . It may also provide an objective measurement of skin thickness and has been used to monitor thinning of hypertrophic scars and before and after laser treatment of atrophic acne scars to measure its effectiveness .…”

Section: Acne Scars: Morphologic Classificationmentioning

confidence: 99%