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Practical Aspects of Cosmetic Testing - How to Set up a Scientific Study in Skin Physiology
von: Joachim W. Fluhr
Springer-Verlag, 2010
ISBN: 9783642050671 , 272 Seiten
Format: PDF, OL
Kopierschutz: Wasserzeichen
Preis: 106,99 EUR
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Practical Aspects of Cosmetic Testing - How to Set up a Scientific Study in Skin Physiology
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
22.5 Setting 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
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