Atlantia-Clinical-Trials-brochure-online-version

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Contents NUTRACEUTICALS & FUNCTIONAL FOODS Introduction.............................................................. 1 Health Areas............................................................. 2 Atlantia Facts............................................................ 4 Facilities.................................................................... 5 Product Areas........................................................... 7 Technologies............................................................ 8 Services.................................................................... 9 Clinical Endpoints................................................... 10

BEAUTY & COSMETICS

Introduction and Product Areas............................ 25 Areas of Expertise.................................................. 26 Clinical Case Study Library.................................... 32 Contact................................................................. 34

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END-TO-END CLINICAL SOLUTIONS

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 maximise the value proposition for each of our clients. Our state-of-the-art clinic sites both in Ireland and the USA ensure we can offer multicentre multinational studies of all design types, across a broad and diverse array of health areas and product portfolios. and dedicated team will help you manage all aspects of your clinical project and guide you through the entire process, while keeping you fully informed of progress. Since we own and operate our clinics we can control the variables, including recruitment. Additionally all of our ICH-GCP certified teams are on hand to ensure your data is of the very highest quality and integrity and in strict accordance with the protocol. Our highly qualified

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Health Areas

CLINICAL RESEARCH EXPERTS ACROSS A VARIETY OF HEALTH AREAS

Some of our extensive clinical areas include: healthy ageing, gastrointestinal function and disorder, physical activity and sports performance, nutritional investigations, stress and cognitive health and decline , cardiovascular health, metabolic syndrome, bone and joint health, immune function and microbiome dysbiosis of the gut, skin, vagina and oral cavity.

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ATLANTIA EXPERTISE: CLINICAL ENDPOINTS

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Atlantia Facts

ATLANTIA FACTS

ON TIME, ON BUDGET

GCP & COLIPA

EXPERIENCED WITH CLAIM SUBMISSION AND PUBLICATION

OVER 150 STUDIES COMPLETED

WE WORK WITH THE TOP MICROBIOME RESEARCHERS WORLDWIDE*

CLINICAL STUDY

FACILITIES IN BOTH USA & EUROPE

*Based on Expertscape and Claritative Analytics classifications

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Facilities

CLINICAL TRIAL FACILITIES

We own and operate our clinical trial facilities, where our clinical research team: Designs the studies, screens participants, conducts the study visits, collects and stores the biological samples and performs the statistical analysis. All trial activities happen here, under one roof, ensuring data quality and compliance across all functions.

• Our facilities have adaptable clinic rooms to ensure privacy and confidentiality during study visits. • Our clinic rooms are adapted and specialised to meet the needs of each specific trial. • Our central phlebotomy facility allows us to perform multiple and frequent blood sample collections.

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CLINICAL TRIAL FACILITIES

• In our processing lab, we manage many different sample types including urine, faecal, blood, hair, and skin. • We can store samples on site at -20°C and -80°C for the duration of the study and beyond. This allows the conduct of further exploratory analysis even once the trial is completed. • Our file & IP Storage unit is compliant with ICH-GCP standards and is also access and temperature controlled. • This allows our clients to conduct further exploratory analysis even once the trial is completed.

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PROVIDING CLINICAL RESEARCH EXPERTISE TO THE NUTRACEUTICAL, MEDICAL FOOD AND BEAUTY INDUSTRIES Our expert research team will work with sponsor(s) to design and conduct the most suitable study, taking into consideration all thespecificrequirements for their investigational product(s):

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TECHNOLOGY Atlantia’s research team keeps up to date with the latest advancements in technology and methods. Our research teamwill assist you selecting themost appropriate technology depending on the product, health area and endpoints of your study.

Video Capsule Endoscopy (VCE)

Continuous Glucose Monitoring

Sports Performance lab

Flow Mediated Dilation and sonographers

Radio Opaque markers (WGTT)

Cognitive test batteries, sleep and mood

Cornometer, Tewameter and Visiometer

DXA Scans, MRI/X-ray

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SERVICES

Trial Design

Regulatory Expertise

Trial Conduct

Reporting

Participant Recruitment

Trial Analysis

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ENDPOINTS AND MEASUREMENTS

GASTROINTESTINAL HEALTH OBJECTIVE ENDPOINTS INDICATION MEASUREMENT Gut Functionality Function: oesophageal pH metry,

faecal weight and consistency; Transit time: radiopaque pellets; Permeability: lactulose-mannitol tracer test; Motility: gastric scintigraphy; VCE-Video Camera Endoscopy Epithelial integrity: histology, mucus secretion; Biomarkers: E-cadherin, growth factors, tight junctionmolecules, lipopolysaccharide (LPS) in blood, a-antitrypsin in faeces; Antimicrobial peptides: a-andb-defensins, calprotectin Immunoglobulins: IgA, IgE; Proteases: tryptase, chymase; Inflammatory cell signalling pathways: MAPK, NFkB, Cox 1 & 2; Inflammation: cytokines (Interleukins (IL) & TNFa), hsCRP, salivary cortisol, stool calprotectin

Gut Integrity

Immunity

/

Inflammation

Microbiota

Shotgun sequencing, functional genomics, metabolomics, transcriptomics, GA-Map.

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GASTROINTESTINAL HEALTH

SUBJECTIVE ENDPOINTS

INDICATION MEASUREMENT GI health

Bristol Stool Scale, Gastrointestinal Symptom Rating Scale (GSRS), IBS Severity Scoring System (IBS-SSS) Health Status Questionnaire (HSQ), Short Form Health Survey (SF)

Well-being

Dietary Analysis

FFQ, 24 hour recall, 3 day diary

BONE & JOINT HEALTH OBJECTIVE ENDPOINTS INDICATION MEASUREMENT Physical performance & functional capacity Hand grip strength (sarcopenia), knee extension & flexion measured by goniometry Bone mass and

Dual-emission X-ray absorptiometry (DEXA); osteoarthritis: X-RAY & Kellgren- Lawrence Gradient Scale interleukins (IL) -1B1, erythrocyte sedimentation rate (ESR), hsCRP, serum osteocalcin, serum hyaluronic acid (HA), serum keratin sulphate, transforming growth factor beta (TGF-B)

bone mineral density (BMD) Inflammatory markers

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BONE & JOINT HEALTH

SUBJECTIVE ENDPOINTS INDICATION MEASUREMENT Osteoarthritis: knee & joint pain, stiffness, symptoms, sport, recreation & physical function Western Ontario & McMaster

Universities Arthritis Index (WOMAC); Knee Injury and Osteoarthritis Outcome Score (KOOS)

Pain Intensity

Visual Analogue Scale (VAS); Numeric Rating Scale (NRS); Verbal Descriptive Scale (VDS); McGill Pain Questionnaire Short Physical Performance Battery (SPPB)

Physical Performance & functional capacity

Quality of Life

Short Form (SF) 36 questionnaire; daily or weekly We-diary

Dietary Analysis FFQ, 24 hour recall, 3 day diary

STRESS & COGNITIVE HEALTH OBJECTIVE ENDPOINTS

INDICATION MEASUREMENT Changes in biological stress indicators Salivary and plasma cortisol; IgA; tryptophan; heart rate

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STRESS & COGNITIVE HEALTH

SUBJECTIVE ENDPOINTS

INDICATION MEASUREMENT Cognitive Function Standardised cognitive test battery e.g.

Cambridge Neuropsychological Test Automated Battery (CANTAB); mini- mental state examination (MMSE) Age specific neurodevelopment tests

Cognitive development in children

Anxiety & Depression

Hamilton Anxiety Rating Scale (HAM-A); Beck depression inventory; Hamilton Depression Rating Scale (HAM-D); Trier social stress test (TSST)

Dietary Analysis

FFQ, 24 hour recall, 3 day diary

MICROBIOME HEALTH

MEASUREMENT Shotgun Metagenomic Sequencing, De Novo Sequencing of Genomes, Flow Cytometry & Fluorescence Activated Cell Sorting (FACS), 16S rRNA sequencing Metabolomics / Lipidomics, Proteomics, Fatty Acid / Bile Acid

Analysis, Transcriptomics, Functional Genomics Standard & Custom Library Generation, PCR Dietary Analysis: FFQ, 24 hour recall, 3 day diary

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CARDIOVASCULAR HEALTH

INDICATION MEASUREMENT Physical performance & functional capacity Exercise / daily activity log; Strength / endurance testing Abnormal Body Fat Distribution Body composition: DEXA; Adipose tissues biomarkers: leptin, adiponectin; Central fat: CT/MRI; Liver fat content: MRS; Weight Management: Dietician Insulin Resistance Elevated fasting glucose: oral glucose tolerance test (OGTT); postprandial insulin; Elevated free fatty acids; Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Hormonal Factors Leptin, ghrelin, cholecystokinin plasma, glucagon-like peptide (GLP) -1 growth hormones, cortisol Vascular Dysregulation Systolic/diastolic blood pressure (BP); Ambulatory BP; Endothelial function: flow mediated dilation (FMD); ACE inhibitor

Thrombosis

Fibrinolytic factors (Plasminogen activator inhibitor-1); Clotting factors (fibrinogen) Cholesterol: total, LDL, HDL; Apolipoprotein A1 & B, Omega 3 fatty acids EPA/DHA, conjugated linoleic acid

Atherogenic dyslipidaemia

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IMMUNE HEALTH

TECHNIQUE MEASUREMENT Flow Cytometry Cytokines: Interferons (IFN) e.g. IFN-g, Interleukins (IL) e.g. IL-1B, IL-6, IL-10, Tumour Necrosis Factors (TNF) Next Generation Sequencing Granulocytes: Neutrophils, Basophils, Eosinophis PCR Glucocorticoid: cortisol; Immunoglobulins (Ig) e.g. IgA, IgE Multiplexed Immunoassay Lymphocytes; T, B and Natural Killer (NK) cells, helper T cells, cytotoxic T cells

ELISA

High-sensitivity C-reactive protein (hsCRP)

Single Cell Analysis e.g. Proteomics

Monocytes / Macrophages

Dietary Analysis

FFQ, 24 hour recall, 3 day diary

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HEALTHY AGEING

INDICATION MEASUREMENT Cardiovascular function

Blood Pressure (BP); Ambulatory BP; Endothelial function e.g. flow-mediated dilation (FMD) GI transit; bowel function; dysphagia; microbiome diversity Hand grip strength; chair stand test; walking test; agility (chair seat and reach); 2 minute step test % lean muscle, bone density, DEXA scan; Measurements: resting heart rate, weight, muscle circumference Plasma essential and non-essential amino acids, total protein, albumin, serum and urinary urea; serum iron, transferrin saturation, iron binding capacity, ferritin levels; plasma and salivary cortisol, IgA, tryptophan, creatinine; glucose; serum triglyceride; omega-3 fatty acids; oxidative stress measurements Bristol Stool Scale, Gastrointestinal Symptom Rating Scale (GSRS), IBS Severity Scoring System (IBS-SSS) Health Status Questionnaire (HSQ), Short Form Health Survey (SF) FFQ, 24 hour recall, 3 day diary

Gastrointestinal function Physical Activity & performance Biometric & Anthropometric measurements Biological Sample indicators

GI function

Well-being

Dietary Analysis

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METABOLIC HEALTH

INDICATION MEASUREMENT Physical performance & functional capacity Body composition: DEXA or Tanita anthropometric measurements (waist circumference, calliper skin fold thickness, body composition analyser (bioimpedance); Adipose tissues biomarkers: leptin, adiponectin; Central fat: CT/MRI; Liver fat content: MRS; Weight Management: Dietician Insulin Resistance Elevated fasting glucose: oral glucose tolerance test (OGTT); postprandial insulin; Elevated free fatty acids; (HOMA-IR) Hormonal Factors Leptin, ghrelin, cholecystokinin plasma, glucagon-like peptide (GLP) -1 growth hormones, cortisol Vascular Dysregulation Exercise / daily activity log; Strength / endurance testing Abnormal Body Fat Distribution

Systolic/diastolic blood pressure (BP); Ambulatory BP; Endothelial function: flow mediated dilation (FMD); ACE inhibitor High sensitivity C-reactive protein (hsCRP); Cytokines: TNF alpha, interleukin-6; Bradykinin;

Inflammation

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METABOLIC HEALTH

INDICATION MEASUREMENT Thrombosis Fibrinolytic factors (Plasminogen activator inhibitor-1); Clotting factors (fibrinogen) Atherogenic dyslipidaemia Cholesterol: total, LDL, HDL; Apolipoprotein A1 & B, Omega 3 fatty acids EPA/DHA, conjugated linoleic acid

Appetite profile Dietary Analysis

Visual analogue scale (VAS)diary FFQ, 24 hour recall, 3 day diary

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PHYSICAL ACTIVITY & SPORTS HEALTH OBJECTIVE ENDPOINTS

INDICATION MEASUREMENT Cardiorespi ratory capacity & Fitness

Cardiopulmonary Exercise Testing (CPET), respiratory oxygen uptake (VO2), carbon dioxide production (VCO2), maximal aerobic capacity (VO2max), anaerobic threshold, fat and carbohydrate metabolism, energy cost of exercise, resting metabolic rate can be assessed Pulmonary Function Tests (PFT) peak expiratory flow (PEF), forced vital capacity (FVP) and forced expiratory volume (FEV) using a spirometer Jumping repetition maximum weight lift (1RM), timed get up and go, chair stand, 6 min walking test, stair climb power test, gait speed, flexibility and range of motion, economy of motion, muscle fatigue, acceleration (accelerometer) height, 1 % lean muscle, bone density, using DEXA scan; Biometric & Anthropometric Measurements: resting heart rate, weight, muscle circumference

Lung Function

Physical Activity & Physical Performance

Body composition measurements

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PHYSICAL ACTIVITY & SPORTS HEALTH OBJECTIVE ENDPOINTS

INDICATION MEASUREMENT Muscle strength & endurance

Biodex Isokinetic Test measures isokinetic (both eccentric and concentric) function and isometric strength on major muscle groups, handgrip strength (arm curl with hand weight); Endurance Capacity: lactate threshold, multi-sprint endurance International Physical Activity Questionnaire (IPAQ)

Physical performance

Well-being

WHO 5 well being index

Dietary Analysis

FFQ, 24 hour recall, 3 day diary

SUBJECTIVE ENDPOINTS

INDICATION MEASUREMENT Physical performance International Physical Activity Questionnaire (IPAQ)

Well-being

WHO 5 well being index

Dietary Analysis

FFQ, 24 hour recall, 3 day diary

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NUTRITIONAL HEALTH OBJECTIVE ENDPOINTS INDICATION MEASUREMENT

Cardiovascular & Metabolic Health

Blood Pressure (BP); Ambulatory BP; Endothelial function e.g.FMD; Inflammatory biomarkers: interleukin-6, C-reactive protein; blood cholesterol: total, LDL, HDL Aerobic capacity/VO2 max, muscle mass / strength % lean muscle, bone density, using DEXA scan; Biometric & Anthropometric Measurements: resting heart rate, weight, muscle circumference Plasma essential and non-essential amino acid; plasma ketones; plasma creatine and urinary nitrogen; plasma glucose, insulin, serum triglycerides, serum and urinary urea, urinary ammonia, serum and urinary protein levels, metabolomics, lipidomics, proteomics

Physical Activity & performance Body composition measurements

Nutrient Analysis

Physical performance

International Physical Activity Questionnaire (IPAQ)

Well-being

WHO 5 well being index

Dietary Analysis

FFQ, 24 hour recall, 3 day diary

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WOMEN HEALTH OBJECTIVE ENDPOINTS

INDICATION MEASUREMENT Cardiovascular health Blood Pressure (BP); Ambulatory BP; Endothelial function e.g. flow- mediated dilation (FMD)

Gastrointestinal health Physical Activity & performance Body Composition measurements

GI transit; bowel function; microbiome diversity Aerobic capacity/VO2 max; muscle max/strength % lean muscle, bone density, DEXA scan; Measurements: resting heart rate, weight, muscle circumference Amsel’s criteria and Nugent scoring system used as diagnostic method and primary outcomes evaluation, reduction in episodes of VI (compared to placebo), Severity of VI symptoms, Duration of VI symptoms, Microbiological profiling (Vaginal Microbiome) inflammatory biomarkers; plasma essential and non-essential amino acids, total protein, albumin, serum and urinary urea; plasma and salivary cortisol, IgA, tryptophan (stress indicators), creatinine; glucose; serum triglyceride; omega-3 fatty acids; oxidative stress measurements

Vaginal infections (VI) follow up

Biological Sample indicators

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WOMEN HEALTH SUBJECTIVE ENDPOINTS

INDICATION MEASUREMENT GI health Physical Activity International Physical Activity Questionnaire (IPAQ) Anxiety & Sleep Quality Hamilton Anxiety Rating Scale (HAM-A) Well-being

Gastrointestinal Symptom Rating Scale (GSRS)

WHO 5 well being index, Quality of life using Assessment of Quality of Life (AQoL), 36-item short form (SF-36)

Dietary Analysis

FFQ, 24 hour recall, 3 day diary

Disclaimer

The previous tables are a description of Atlantia’s expertise, however they are not an exhaustive list of associated indications and measurements. Contact us to get a specific proposal depending on your investigational objectives, product, skin condition and desired population.

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EXPERTS TO THE BEAUTY & PERSONAL CARE INDUSTRY

Atlantia has expertise in SkinMicrobiome and Dermatology trials for cosmetics and consumer products, helping you to innovate in a competitive marketplace. Our team can design a trial based on your objectives, to investigate the safety and efficacy of new ingredients or final products, providing claim substantiation to support your product portfolio. Atlantia is a world class company in delivering clinical studies: we perform acute, observational and intervention studies to ICH- GCP & COLIPA standards for cosmetics, functional ingredients, supplements, pre- and probiotics. After having spun out of the world-renowned APC Microbiome Institute, we have developed a unique business model that combines very strong ties with the academic community, but operates as an independent contract research organisation (CRO) where the Intellectual Propertry belongs to the sponsor. 25

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AREAS OF EXPERTISE

SKIN/FACE CARE: Efficacy Studies OBJECTIVE ENDPOINTS

TEST

MEASUREMENT

Anti-wrinkle/texture Wrinkles, fine lines, texture, pores, acne scars and volumes, selected in several zones of the face are analyzed using our Antera3D imaging camera Firmness/Elasticity Our Cutometer® is used to measure viscoelastic properties of the skin Dark Spots/Age Spots Pigmentation, Vascular Lesions, Brown spots, hyper-pigmentation, rosacea, port wine stains can be measured using our Antera3D imaging camera Skin Protection /Repair The skin protective barrier function

is assessed by measuring Trans- Epidermal Water Loss (TEWL) with our Tewameter® Skin surface pH can be measured using a Skin pH meter

Skin pH

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SKIN/FACE CARE: Efficacy Studies OBJECTIVE ENDPOINTS

TEST

MEASUREMENT

Skin brightening

Skin colour, phototype, ITA angles and colour differences can be measured using our Antera3D imaging camera

Ant i -Sebum/Sebum Control The sebum levels of the skin may be measured with our Sebumeter® Lip dryness/Lip Balm The hydration of lips superficial layers may be measured with our Corneometer® Hydrating/Moisturising Our Corneometer® measures the hydration on the superficial layers of the skin

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SKIN/FACE CARE: Efficacy Studies SUBJECTIVE ENDPOINTS

TEST

MEASUREMENT

Eczema

Eczema Area and Severity Index (EASI)

Skin dryness & presence of skin tears Overall Dry Skin (Xerosis) Score (ODS): 5 point clinical assessment of skin dryness Lip dryness/Lip Balm Lip dryness is evaluated by volunteerss Measure of pruritis 5-Dimension (Degree, Duration, Direction, Disability & Distribution) Itch Scale

Self-reported measure Quality of Life (QoL)

Dermatology QoL

Dietary Analysis

Dietary Analysis: FFQ, 3 day diary

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SKIN/FACE CARE: Microbiome Studies MICROBIOME ENDPOINTS

TEST

MEASUREMENT

Skin sampling techniques

Swabbing, tape stripping, D-squame sampling and punch biopsy Sequencing, Transcriptomics, Functional Genomics, Flow Cytometry, PCR

Profiling of Skin Microbiota

Profiling of Skin Lipids Lipidomics

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COSMETIC TESTING

TEST

MEASUREMENT

Foundation/Concealer Skin tone homogeneity, mattifying effect, imperfection coverage and long-lasting product can be assessed Lipstick

The appearance of the lips is analyzed to determine the glossy and the long-lasting effects of the product. In addition, the hydrating effect can be measured via the corneometer Standardized digital photographs are taken with the Antera 3D imaging system. A specialized software analyzes a zone of interest to evaluate skin tone evenness and skin color.

Self-Tanning

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Disclaimer

The previous tables are a description of Atlantia’s expertise, however they are not an exhaustive list of associated indications and measurements. Contact us to get a specific proposal depending on your investigational objectives, product, skin condition and desired population. LEARN MORE ABOUT OUR SKIN MICROBIOME RESEARCH On-Demand Panel Discussion: Skin

Microbiome from a Clinical Development Perspective Including clinically proven ingredients will increase the success of a product. Join us on this panel discussion with experts in academic research, in vitro

& in vivo commercial research.

Available through this link

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CLINICAL RESEARCH LIBRARY

QR CODE CASE STUDY

Assessing FMD in overweight adults

Digestive Discomfort Clinical Trial

Video Camera Endoscopy Clinical Trials

IBS Research & Probiotics

Sleep & Immunity Research

Probiotics

and

Weight

management

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LEARN MORE ABOUT OUR SKIN RESEARCH

On-Demand Webinar: Antimicrobial potential of the human skin microbiota

Join Dr. Julie O’Sullivan to understand her research on the area of skin microbiome and how to translate those advancements into final cosmetic products thanks to the validation through human clinical trials. What kind of biomarkers and other considerations to take on board.

Available through this link

Case Study: Assessing Trans-Epidermal Water Loss, Skin Hydration and Firmness

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.

Available through this link

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OUR TEAM CAN GUIDE YOU Create the right study design to support your research program

REACH OUT TO OUR SKIN RESEARCH EXPERTS

sales@atlantiatrials.com

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