Practical Aspects of Cosmetic Testing (eBook)

How to Set up a Scientific Study in Skin Physiology

Joachim W. Fluhr (Herausgeber)

eBook Download: PDF

2010 | 2011
XI, 272 Seiten
Springer Berlin (Verlag)
978-3-642-05067-1 (ISBN)

Infos

Skin physiology assessment is moving rapidly from a descriptive approach to a deeper understanding of biophysical and biochemical processes in the stratum corneum, e.g. on stratum corneum barrier function as well on stratum corneum hydration. The research with bioengineering methods offers now reliable and reproducible approaches for product testing in the pharmaceutical and cosmetic industry as well as in basic research. This cookbook is intended to give basic information regarding skin physiology, the assessment of skin functions in controlled studies using non-invasive biophysical instruments. It provides basic knowledge on how to plan, perform and evaluate scientific studies. The authors are recognized expert in the field and provide comprehensive chapters with specific emphasis on the practical aspects of non-invasive measurements.

Inhalt

Preface 5
Contents 6
Introduction: History and Progress of Objective Skin Analysis 8
Part I:Legal Aspects of Cosmetic Testing 11
1: Regulatory Aspects 12
1.1Comparison Between General Cosmetic Legislation in Europe and Other Countries 13
1.2Recent Changes in European Cosmetic Regulation 14
1.3Important Weblinks 15
1.3.1European Union 15
1.3.2USA 15
1.3.3Canada 16
1.3.4Japan 16
1.3.5Mercosur Countries (Examples) 16
1.3.6ASEAN Countries (Example) 16
1.3.7South Africa 17
1.3.8China 17
1.3.9India 17
1.4Cosmetic Safety Testing 17
1.5Responsibility Considerations for Planning and Conduct of a Cosmetic Safety Study 18
1.6Frequent Cosmetic Safety Study Models 19
1.7Cosmetic Efficacy Testing 20
1.8Cosmetic Labeling and Packaging 21
References 22
2: Ethical Aspects of Cosmetic Testing 23
2.1Introduction 23
2.2Brief History of Research Ethics 24
2.3Ethical Aspects of Cosmetic Testing 27
2.4Ethical Aspects of Noninvasive Skin Measurements 27
2.5Essential Ethical Requirements for Performing a Study 28
2.5.1Principles Related to Study Conduct 28
2.5.2Principles Related to Study Investigator 28
2.5.3Principles Related to Study Subjects/Participants 29
2.5.4Principles Related to Investigational Products 29
2.5.5Principles Related to Measuring Techniques/Devices 30
2.5.6Principles Related to Institutional Review Board/Independent Ethics Committee (IRB/IEC) 30
2.5.7Other Considerations 30
2.6Conclusion 31
2.7Key Messages for Performing an Ethical Study 31
References 31
3: Good Clinical Practice 34
3.1Principles of GCP 34
3.2Standard Operating Procedures (SOPs) 36
3.3Study Design and Protocol Standards 37
3.4Conduct Standards 37
3.5Recording and Reporting Standards 37
References 38
4: Guidelines in Dermocosmetic Testing 39
4.1Introduction 39
4.2Skin Bioengineering Endeavor 40
4.3Validation of Methods and Instrumentations 41
4.4A Plea for Standardization and Quality Controls 41
4.5Search for “Good Biometrological Practice” 42
4.6Guidelines in Perspective 44
4.7Conclusion 45
References 46
5: Claim Support: How to Create and Substantiate Claims 48
5.1Introduction: Cosmetic Claims and Cosmetic Product Testing 48
5.1.1What Is a Cosmetic Claim? 49
5.1.2Borderline Claims 50
5.2The Process of Creating Cosmetic Claims 50
5.2.1Global or Regional 52
5.2.2Communication Style and Medium 52
5.2.3Consumer Factors 53
5.3Deciding How to Support a Claim 53
5.3.1 Classifying Claims 54
5.3.2Level of Evidence 55
5.3.2.1Established and Widely Available Evidence 55
5.3.2.2Established Rationale but Requiring Specific Evidence 57
5.3.2.3Evidence Based upon Significant Advance in Science or Technology 58
5.4Generating Information to Support Claims 58
5.5Presenting Information in Support of a Claim 63
5.6State of the Art 64
5.7Conclusion 65
References 65
Part II:General Aspects of Cosmetic Testing 67
6: Testing Laboratory 68
6.1Requirements for Accommodation and Arrangement 69
6.1.1Reception/Volunteer Recruitment Office 70
6.1.2Data Base/Subject File Room 70
6.1.3Waiting Area for Volunteers 70
6.1.4Room for Conducting General Volunteer Information Sessions 71
6.1.5Investigator’s Office(s)/Examination Room(s) 71
6.1.6Testing Lab Room(s) 71
6.1.7Staff Office(s) 72
6.1.8Rest Rooms for Volunteers 72
6.1.9Test Product/Sample Storage Room 72
6.2Requirements for Ambient Conditions 73
6.3Laboratory Quality Management System 73
6.3.1General Quality Management 73
6.3.2Measurement Devices Quality Management 74
References 75
7: Research Staff 77
7.1Requirements for Qualification and Training of Study Nurses and Investigators 77
7.1.1Investigator 77
7.1.2Study Assistant (Study Nurse) 79
8: Testing Population 80
8.1Advertisements 81
8.2Telephone Recruitment 82
8.3Recruitment through Third Parties/Intermediaries 82
8.4Acquisition Criteria and Screening 82
8.5Product-Related Information and Compliance 83
9: Testing Devices and Methods 84
Core Messages 84
9.1Introduction 84
9.2Technical Assessment of the Various Skin Parameters 85
9.3The Measurement Technique and Norms, Standards and Directives 86
9.4The Practical Use of Measurement Devices 87
9.4.1Factors Within the Laboratory 87
9.4.2Factors Influencing the Choice of the Most Suitable Measurement Device 88
References 88
10: Factors Influencing Measurements 90
10.1Introduction 90
10.2Sources of Error and Associated Variables 91
10.2.1Instrument-Related Variables 91
10.2.1.1Instrumental Variability, Start-Up, and Use 91
10.2.1.2Measurements 92
Surface Area 92
Contact Time 92
10.2.2Environment-Related Variables 92
10.2.2.1Air Convections 92
10.2.2.2Ambient Air Temperature 93
10.2.2.3Ambient Air Humidity 93
10.2.2.4Light Sources 93
10.2.2.5Skin Cleansing 93
10.2.3Individual-Related Variables 94
10.2.3.1Age, Sex, and Race 94
10.2.3.2Anatomical Sites 94
10.2.3.3Sweating 95
10.2.3.4Skin Surface Temperature 95
10.2.3.5Skin Damage and Diseases 96
10.2.3.6Circadia/n Rhythm 96
10.2.3.7Intra- and Interindividual Variation 96
10.3Conclusions 97
References 98
11: Study Design 101
Core Messages 101
11.1Determination of Study Design 102
11.2Study Objective(s) 102
11.3Measurement Variables and Endpoints 103
11.4Statistics 103
11.4.1Sample Size Calculation 103
11.4.2Statistical Methods 104
11.5Ethical Review and Scientific Validity 104
11.6Provision for Test Products 104
11.7Provision for Test Persons 105
11.8Study Documents 105
11.8.1Study Protocol 105
11.8.2Subject Information Sheet 105
11.8.3Case Report Form and Subject Diaries 106
11.9Data Processing 106
References 106
12: Cosmetic Testing Report 107
12.1Introduction 107
12.2Report Structure and Contents 108
12.2.1Title Page 108
12.2.2Synopsis (Study Summary) 109
12.2.3Table of Contents 109
12.2.4List of Abbreviations (If Applicable) 109
12.2.5Ethics 109
12.2.6Investigators and Study Administrative Structure 109
12.2.7Introduction 110
12.2.8Study Objectives 110
12.2.9Investigational Plan (Material and Methods) 110
12.2.10Results 111
12.2.11Discussion and Conclusions 111
12.2.12Reference List 112
12.2.13Signatures 112
12.2.14Appendices (Attachments) 112
12.3How to Publish the Results 112
12.3.1Title Page 113
12.3.2Conflict of Interest Notification Page 113
12.3.3Abstract (Summary) 113
12.3.4Keywords 114
12.3.5Introduction 114
12.3.6Material and Methods 114
12.3.7Results 114
12.3.8Discussion and Conclusions 115
12.3.9Acknowledgments 115
12.3.10References 115
12.3.11Tables and Figures 115
12.3.12Tables and Figures Legends 115
12.3.13Sending the Manuscript to the Journal 115
12.4Conclusions 118
References 118
Part III:Practical Aspects of Testing: Typical Examples of Test Settings 120
13: Moisturizers and Emollients 121
13.1Introduction 122
13.1.1Moisturizers and Emollients – What Are They? 122
13.1.2Natural Sources for the Skin Hydration 122
13.1.3Legislation and the Marketplace of Moisturizing Cosmetics 123
13.2Non-Invasive Biophysical Methods in Testing Moisturizers and Emollients 124
13.2.1Evaluation of the Electrical Properties of the Outermost Skin Layers 126
13.2.2Transepidermal Water Loss Assessment 126
13.2.3Instrumental Evaluation of the Skin Topography 127
13.2.4Spectroscopic and Optical Properties of the Skin 128
13.2.5Evaluation of the Mechanical/Visco-Elastic Properties of the Skin 128
13.3Practical Aspects of Moisturizers Testing 129
13.3.1Selection of the Investigative Method 129
13.3.2Study Design 129
13.3.2.1Single Application Tests 129
13.3.2.2Multiple Application Tests 130
13.3.2.3Regression Tests 130
13.3.2.4Efficacy on Pre-Irritated Skin 130
Remark 131
13.3.3Study Population 131
13.3.3.1General Considerations 131
13.3.3.2Number of Subjects 132
13.3.3.3Individual-Related Variables Influencing the Biophysical Measurements 132
13.3.4Test Site 132
13.3.5The Study Procedures 134
13.3.5.1Instructions to the Panelist 134
13.3.5.2The Washout Phase 134
13.3.5.3Environment-Related Variables Influencing the Measurements and the Panelist Acclimatization 134
13.3.5.4The Product Application 136
13.3.5.5The Measurement 137
13.3.5.6Data Management and Evaluation 137
13.4Conclusion 138
References 138
14: Antiaging and Antiwrinkle Products 140
14.1Introduction 141
14.2Methods Used in the Evaluation of Antiaging Products 141
14.2.1Clinical Assessment 143
14.2.2Non-invasive Biophysical Methods 143
14.2.2.1Instrumental Evaluation of the Skin Surface Topography 143
14.2.2.2Epidermal Barrier Function by Transepidermal Water Loss Assessment 144
14.2.2.3Evaluation of the SC Hydration by Electrical Methods 144
14.2.2.4Skin Pigmentation and Color 145
14.2.2.5Skin Surface Acidity (pH) 145
14.2.2.6Assessment of Skin Microcirculation 145
14.2.2.7Assessment of Skin Surface Lipids by Photometric Methods 145
14.2.2.8Assessment of the Skin Mechanical Properties 146
14.2.3Invasive Procedures 146
14.3Study Design for Testing Antiaging Products 146
14.3.1Study Population 147
14.3.2Study Duration 148
14.3.3Test Site 148
14.3.4Product Application 148
14.3.5Efficacy Assessment 149
14.3.6Data Management and Evaluation 149
14.4Conclusion 149
References 150
15: Products for Impure, Acne-Like Skin 151
15.1Introduction 151
15.2Test Settings 152
15.2.1Study Background 152
15.2.2Study Objectives 152
15.2.3Material and Methods 152
15.2.3.1Study Products 152
15.2.3.2Study Subjects 153
15.2.3.3Study Design 154
15.2.3.4Study Methods 154
Oily Skin Assessment 155
Sensorial Assessment 155
Instrumental Assessment 156
Quality of Life Assessment 157
Acne Lesions Assessment 157
Sensorial Assessment 158
Instrumental Assessment 160
Quality of Life Assessment 161
Product Acceptance Assessment 161
Assessment of Unwanted Effects 162
15.2.3.5Study Protocol 162
15.2.3.6Study Ethics 163
15.2.3.7Statistical Analysis 163
15.3Conclusion 163
15.4Key Messages 163
References 164
16: Assessment of Hair Morphology 167
16.1Introduction 167
16.2Material and Methods 168
16.2.1Optical Interferometry 168
16.2.2Static and Dynamic Experiments 169
16.3Results and Discussion 170
16.3.1Static Experiments 170
16.3.2Dynamic Experiments 171
16.4Conclusions 173
References 174
17: Skin Colour and Pigmentation 175
17.1Introduction 175
17.2Skin Colour 176
17.3Individual Differences 176
17.4Instruments 178
17.4.1Reflectance Spectrophotometric Evaluation 178
17.5Study Procedure 179
References 181
18: Characterization of Sunscreens: Determination of the SPF 182
18.1Introduction 183
18.2UVB Protection 183
18.3Example for the SPF Determination 184
18.3.1Determination of MED 184
18.3.2 Sunscreen Application 185
18.4International Methods for the SPF Determination 186
18.5Determination of the UVA Protection Factor 186
18.6Classification of Sunscreens 187
18.7Outlook 188
18.8Summary 188
References 189
19: Practical Aspects of Shampoo and Conditioner Testing 191
19.1Introduction 191
19.2Hair Science Overview 192
19.3Shampoos: An Overview 194
19.42-in-1 Shampoo+Conditioners: An Overview 196
19.5Conditioners: An Overview 198
19.6Evaluation Approaches 199
19.7Consumer Evaluation Approaches 199
19.8Technical Evaluation Approaches 200
19.9Assessing Surface Damage: Microscopy 202
19.10Lubrication 202
19.11Strength 204
19.12Static Electricity Retardation 205
19.13Shine 205
19.14Color Fade 206
19.15Moisturization 207
19.16Summary 208
References 209
20: Antiperspirants and Deodorants 210
20.1Introduction 211
20.2Antiperspirants and Deodorants: What Are They? 212
20.3Testing Efficacy of Antiperspirants 212
20.3.1Test Methods 212
20.3.2Test Design 213
20.3.2.1Gravimetric Evaluation of the Armpit Sweating 213
Study Population 214
The Conditioning Phase 214
Test Procedure 214
Data Evaluation 215
20.3.2.2Multiple Product Test Design 216
Study Population 216
The Conditioning Phase 216
Test Procedure 216
Data Evaluation 216
20.4Testing Efficacy of Deodorants 217
20.4.1Test Methods 217
20.4.2Test Design 217
20.4.2.1Sniff Test 217
Study Population 217
The Conditioning Phase 218
Test Procedure 218
Data Evaluation 218
20.5Conclusion 218
References 219
21: Hair Growth 220
21.1Keypoints 221
21.2Introduction 221
21.3Study Design 222
21.4Assessment of Clinical Appearance (Investigator’s Questionnaire) 222
21.5Clinical Grading Systems 223
21.6Daily Hair Count 223
21.7Hair Wash Test 224
21.8Hair Pull-Test 224
21.9Hair Weighing 225
21.10Trichogram 225
21.11Unit Area Trichogram 227
21.12Phototrichogram 227
21.13Contrast-Enhanced Phototrichogram 228
21.14Epiluminescence Microscopy of Hair (TrichoScan) 228
21.15Global Photographs 231
21.16Optical Coherence Tomography of Hair 231
21.17Electron Microscopy of Hair 233
21.18Confocal Laser Scanning Microscopy of Hair 233
21.19Conclusions 233
References 236
22: Sensory Perception 239
22.1Introduction 239
22.2Sensitive Skin 239
22.3Underlying Mechanisms 240
22.4Testing Sensory Perception 241
22.5Setting Up a Test 242
22.6Interpretation 243
References 244
23: Practical Use and Significance of Transepidermal Water Loss Measurements 245
23.1The Bricks and the Mortar Model 245
23.2Instrumental Assessment of Epidermal Barrier Status and Repair 246
23.2.1Industrial vs. Legislation Needs to Measure Barrier Status and Repair 246
23.2.2How to Assess the Positive Impact of Body Lotions and Protective Creams on Permeability Barrier Function? 246
23.2.3Finding the Right Formula! 248
23.2.4How Valid Is TEWL to Measure Skin Barrier? 248
23.2.5Few Examples of Currently Used Instruments for Measuring Water Loss 248
23.3Limits and Pitfalls of TEWL Measurement 249
References 250
24: Compliance Check with On-Site Measurements: Advanced Ways in Product Testing 252
Core Messages 252
24.1Introduction: Classical Laboratory Test 252
24.2Efficacy Tests in the Real Environment of the Consumer (Field Studies) 253
24.3The Device Corneometer® Mobile Data Collector DC 3000 254
24.4Conclusion/Perspective 255
References 256
Index 257

Produkt-Details

• Erscheint lt. Verlag: 10.11.2010
• Zusatzinfo: XI, 272 p.
• Verlagsort: Berlin
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Dermatologie
• Schlagworte: Assessment • biophysical and biochemical process • clinical study • cosmetic products • Evaluation • non-invasive biophysical method
• ISBN-10: 3-642-05067-0 / 3642050670
• ISBN-13: 978-3-642-05067-1 / 9783642050671