Atlantia is a world-class provider of human clinical studies. For over a decade we have delivered clinical results to our many clients around the world, on time and on budget. We strive to offer the highest quality science while maintaining a cost-conscious approach to maximize the value proposition for each of our clients.
SKIN RESEARCH CASE STUDY Assessing Trans-Epidermal Water Loss, Skin Hydration and Firmness
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SKIN RESEARCH CASE STUDY
Executive Summary A Healthy skin is influenced by a complex interplay of many factors. This case study presents a clinical trial that aimed to assess the effect of an oral supplement on some of these skin dimensions. Challenges and Objectives The primary objective of this clinical trial was to determine the effect of 12-week daily consumption of an oral supplement as compared to a placebo on Trans-Epidermal Water-Loss (TEWL). Other objectives of this clinical trial were to determine: • Skin hydration • Skin firmness • Subjective evaluation of Skin Quality, Hydration, Moisture and Elasticity • Omega-3-index • Skin Lipid content How Atlantia’s Solution Helped
The team experience designing and conducting skin studies to support a health claim was a key factor of success on this partnership. Atlantia
The Atlantia team were trained and skilled to assess skin indications through specific study equipment. Their experience designing and conducting studies to ICH-GCP standards was a key success facror of this partnership.
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SKIN RESEARCH CASE STUDY
About the Study The study was a randomised, double- blinded, parallel, placebo-controlled clinical trialwithahealthyadultpopulation. The study involved visits over a 15-week period to complete a 12-week intervention period with collection of study objectives at participants visits. Trans-Epidermal Water Loss (skin barrier function) was assessed using TEWAMeter®, skin hydration using Corneometer®, skin firmness using Cutometer® and Omega- 3-index using finger prick blood test. Subjects were screened to identify eligible participants. All participants were randomised. Volunteers consumed one capsule of investigational product orally each morning of the intervention period. Prior to the screening visit, participants completed the consenting process and provided informed written consent. Participants completed a screening visit to evaluate their eligibility for the study, and if the participant met all eligibility requirements, they were scheduled for the next visit. At further visits, participants were assessed for eligibility and if all
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inclusion/exclusion criteria were met, baseline assessments were completed, and participants were randomised to one of two treatment groups in a ratio of 1:1. There were interesting findings regarding improvement in TEWL and Omega-3 Index blood spot levels after 12 weeks of supplementation of the investigational supplement, compared toplacebo.While therewereoutliers in thedata, this isnot unusual given the myriad of factors that can impact TEWL. Further investigation may provide further information on these significant findings.
atlantiaclinicaltrials.com
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SKIN RESEARCH CASE STUDY Assessing Trans-Epidermal Water Loss, Skin Hydration and Firmness
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