Cosmetics: Controlled Efficacy Studies and Regulation

324 Pages·1999·41.924 MB·English

by  G. N. McEwen Jr, E. G. Murphy (auth.), Prof. Dr. med. P. Elsner, Howard I. Maibach M.D., Prof. Dr. med. Hans F. Merk (eds.)

P. Elsner H.E Merk H.I. Maibach (Eds.)
Cosmetics -
Controlled Efficacy Studies and Regulation
Springer
Berlin
Heidelberg
New York
Barcelona
Hong Kong
London
Milan
Paris
Singapore
Tokyo
P. Elsner H.E Merk H.I. Maibach (Eds.)
Cosmetics
Controlled Efficacy Studies
and Regulation
With a Preface by Fritz H. Kemper
i
Springer
Prof. Dr. med. P. Elsner Prof. Dr. med. Hans F. Merk
Klinikum der Rheinisch-Westfalische Technische
Friedrich Schiller-Universitat Jena Hochschule Aachen
Klinik fUr Hautkrankheiten Hautklinik
Erfurter Stra15e 35 Pauwelsstra15e 30
D-07740 Jena, Germany D-52074 Aachen, Germany
Howard I. Maibach, M.D.
Professor
University of California San Francisco
School of Medicine
Department of Dermatology
Box 0989, Surge 110
San Francisco, CA 94143-0989, U.S.A.
ISBN-13: 978-3-642-64160-2 Springer-Verlag Berlin Heidelberg New York
Library of Congress Cataloging-in-Publication Data
Cosmetics: controlled efficacy studies and regulation / P. Elsner ... (ed.) -
Berlin; Heidelberg; New York ; Barcelona; Hong Kong; London; Milano; Paris; Singapore: Springer, 1999
ISBN-13: 978-3-642-64160-2 e-ISBN-13: 978-3-642-59869-2
001: 10.1007/978-3-642-59869-2
This work is subject to copyright. All rights are reserved, whether the whole or part of the materials is concerned,
specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on micro
film or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only
under the provisions of the German Copyright Law of September 9, 1965, in its current Version, and permission for
use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright
Law.
© Springer-Verlag Berlin Heidelberg 1999
Softcover reprint of the hardcover 1st edition 1999
The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in
the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and
therefore free for general use.
Product liability: The publisher cannot guarantee the accuracy of any information about dosage and application
contained in this book. In every individual case the user must check such information by consulting the relevant
literature.
Cover design: design & production, Heidelberg
Typesetting: Goldener Schnitt, Sinzheim
SPIN: 10652697 22/3134 543210 Printed on acid-free paper
Contents
General Background
Cosmetic Claim Substantiation in the United States;
Legal Considerations
G.N. McEwen Jr. and E.G. Murphy .................................. .
2 The Contribution of the European Cosmetics Directive
Towards International Harmonization:
Impact on the Evaluation of Safety and Efficacy
Ph. Masson ................... . 20
3 Claim Support in Japan: Legal Aspects
H. Tagami ... 36
4 Claim Support: Ethical Aspects for Conducting Human Studies
V.Zuang ..................................... . 50
Efficacy
5 In Vivo Evaluation of the Hydration State of the Skin:
Measurements and Methods for Claim Support
A.a. Barel, P. Clarys, and B. Gabard ........................•..•... 57
6 Oily Skin: Claim Support Strategies
R.L. Rizer 81
7 On the Problems of In Vivo Cleansing of the Human Skin
K. Schrader ......................... . 92
8 Methods for Antiperspirant and Deodorant Efficacy Evaluations
J.w. Wild,J.P. Bowman,and L.P. Oddo ... . . .. . .. . . . . . . . ... . ... . .. . . ... 107
VI
(on!en!~
9 Sunscreens
B. Gabard ....................................•........•..•....... 116
10 Self-or Sunless Tanning Lotions
S.B.Levy ..... 13S
11 Anti-Dandruff
U.-E Haustein and P. Nenoff ..... . 140
12 Efficacy of Barrier Creams (Skin Protective Creams)
H.Zhai and H.LMaibach .......................................... 156
13 Anti-Cellulite
C. Rona and E. Berardesca .. . ....... 167
14 Methods for Claim Support in Cosmetology: Hair Cosmetics
LJ. Wolfram .......................... . 17S
15 Racial Differences in Skin Function: Related to Claim Support
E. Berardesca and H.I. Maibach ..................................... 187
16 The In Vivo Biomechanical Testing of the Skin
and the Cosmetological Efficacy Claim Support: A Critical Overview
L Rodrigues .............. . .. ... 197
17 Skin Gloss Metry
V. Wienert ............•..•......•..•...........•................. 209
Safety
18 Hypoallergenic Cosmetics
P.G. Engasser and H.I. Maibach ...... 217
19 The Use of Sensitive Skin Panels to Substantiate Cosmetic Claims
E.M. Jackson ..................................................... 222
20 Fragrances Between Allergic, Hypoallergic, and Irritant: In Vitro Studies
S. Sieben, B. Blomeke, and H.E Merk .. . . .. . .. . . .. . . . ... . .. . . .. . . ... .. 226
21 Contact Urticaria Syndrome (CUS) and Claims Support
5.1. Bashir and H.I. Maibach .....•........ 241
22 Photoreactions
N.J. Neumann, B. Homey, H.W. Vohr,and P. Lehmann . . .•. .•. . . .. 251
Contents VII
23 Comedogenesis
C. Pierard-Franchimont and G.E. Pierard . . . . . . .. . . .•. .... . ... . .. . . ... 268
24 Antimicrobial and Preservative Efficacy
M. Heinzel ...................... . . ... .•. .•. . . . ... 275
25 Mutagenicity
R.D. Combes .. 291
Subject Index ... 309
List of Contributors
prof. Andre O. Barel Dr. Robert D. Combes
Laboratory of General and Biological FRAME
Chemistry 96-98 North Sherwood Street
Faculty of Physical Education and NG 14EE
Physiotherapy Nottingham, U.K.
Free University of Brussel (VUB)
8-1050 Brussel, Belgium Tamotsu Ebihara, M.D.
Saiseikai Central Hospital
Saqib J. Bashir, MD Shinyo CK Building 6 F
University of California 3-3-5, Kam-hsaki, Shinagawer-ku
School of Medicine Tokyo 141-0021,Japan
Box 0989, Surge 110
Patricia G. Engasser.MD
San Francisco, CA 94143, U.S.A.
Department of Dermatology
Kaiser Permanente Medical Center
Enzo Berardesca, MD
1150 Veterans Blvd.
Department of Dermatology
Redwood City. CA 94063-2037, U.S.A.
!ReCS Policlinico S. Matteo
1·27100 Pavia, Italy
Dr. Bernard Gabard
Department of Biopharmacy
Dr. B. Blomeke
Spirig Ltd., Pharmaceuticals
Hautklinik def Medizinischen Fakultat
CH-4622 Egerkingen, Switzerland
der RWTH Aachen
PauweisstraGe 30 Prof. Dr. Uwe-Frithjof Haustein
D-52074 Aachen
Department of Dermatology
University of Leipzig
James P. Bowman
LiebigstraBe 21
Hill Top Research, Inc.
D-04103 Leipzig, Germany
P,O.Box 429501
Miamiville Prof. Dr. M. Heinzel
Cincinnati, OH 45242, U.S.A. Henkel KGa
Henkelstr.67
Dr. Peter Clarys D-40191 DUsseldorf, Germany
Laboratory of General and Biological
Chemistry B. Homey
Faculty of Physical Education and Department of Dermatology
Physiotherapy Heinrich -Heine-University DUsseldorf
Free University of Brussel (VUB) Moorenstr.5
B-I050 BrusseJ, Belgium D-40225 DUsseldorf, Germany
x list of Contributors
Edward M. Jackson, Ph.D. Emalee G. Murphy
Jackson Research Associates, Inc. Securing the Industry's Future Since 1894
20203121" Street Court E 1101 17th SI., N.W.
Sumner, WA 98390, U.S.A. Suite 3000
Washington DC 20036-4702, USA
Tsuneo Jinnai
Sansho Seiyaku Co., LTD Dr. Pietro Nenoff
2-26-7, Oh-ike,Ohnojo-shi Department of Dermatology
Fukuoka Prefecture, 816-8550, Japan University of Leipzig
0-04103 Leipzig, Germany
Prof. Or.med. P. Lehmann
Heinrich-Heine-University of Dusseldorf Dr. N.J. Neumann
Department of Dermatology Department of Dermatology, Andrology
MoorenstraGe 5 Heinrich-Heine-University Dusseldorf
D-40225 Dusseldorf, Germany MoorenstraBe 5
0-40225 Dusseldorf, Germany
Stanley B. Levy. M.D.
Linda P. Oddo
Clinical Professor
Hill Top Research, Inc.
Department of Dermatology
Scottsdale,Arizona, U.S.A.
University of North Carolina at Chapel
Hill
Prof. C. Pii!rard-Franchimont
891 Willow Drive
Centre Hospitalier Universitaire de Lil!ge
Chapel Hill, NC 27514, U.S.A.
Service Dermatopathologie
Domaine Universitaire du Saint Tilmann
Philippe Masson, Ph.D.
8.35
Expert Toxicoloque Pharmacologue
B-4000 Lil!ge I, Belgien
President Directeur General
Laborataire De recherche et
Prof. G.E. Pii!rard
D'Experimentation
Centre Hospitalier Universitaire de Lil!ge
I, rue Massue
Service Dermatopathologie
Vincennes F-94300, France
Domaine Universitaire du Saint Tilmann
B.35
Gerald N. McEwen,Jr., Ph.D., J.D.
8-4000 Lil!ge I, Belgien
The Cosmetic, Toiletry, and Fragrance
Association Ronald L. Rizer, Ph.D.
1l0117thSt.,N.W. Thomas J. Stephens & Associates, Inc.
Suite 3000 3310 Keller Springs Road
Washington DC 20036-4702, USA Suite 130
Carrollton TX 75006, U.S.A.
prof. Dr. med. Hans F. Merk
Hautklinik der Medizinischen Luis Rodrigues, Ph.D.
Fakultat der RWTH Aachen Professor of Human Physiology
PauwelsstraBe 30 Laboratory of Experimental Physiology
0-52074 Aachen, Germany Faculdade de Farma(fia da Universidade
de Lishoa
Av. Das Forps Armadas
1600 Lisboa, Portugal
list of Contributor<; XI
Claudia Rona Prof. Dr. med. V. Wienert
Department of Dermatology Universitatshautklinik
IRCCS Policlinico S. Matteo der RWTH Aachen
1-27100 Pavia. Italy PauwelsstraBe 30
0-52074 Aachen,Germany
Noriko Satoh, M.D.
Yanagihara Hospital John E. Wild
Shinyo CK Building 6 F Hill Top Research, Inc.
3-3-5, Kam-hsaki.Shinagawa-ku P.O.Box 42950 1
Tokyo 141-0021.Japan Miamiville
Cincinnati, OH 45242, U.S.A.
Dr. Karlheinz Schrader
Institutes Dr. Schrader Leszek J. Wolfram, M.D.
Max-Planck-StraBe 6 666 Westover Rd.
0-37603 Holzminden.Germany Stamford, CT 06902, U.S.A.
Dr. S. Sieben Hongbo Zhai, M.D.
Hautklinik der Medizinischen Fakultat Assistant Research Dermatologist
der RWTH Aachen Department of Dermatology
PauweisstraBe 30 University of California
D-52074 Aachen, Germany School of Medicine
San Francisco, CA 94143, U.S.A.
Hachiro Tagami, M.D.
Department of Dermatology Dr. Valerie Zuang
Tohoku University School of Medicine European Centre for the Validation of
Sendai 980-8574, Japan Alternative Methods (ECVAM)
Environment Institute
H.W. Vohr Joint Research Centre of the European
Bayer Vital GmbH & Co KG Commission
0-51368 Leverkusen.Germany 1-21020 Ispra (Va), Italy