cosmeceutiqol: a tool for assessing dermo-cosmetic products’ impact on quality of life

6
Correspondence: Dr. Charles Taieb, Public Health and Quality of life Pierre, Fabre, 45 Place Abel Gance, Boulogne, 92100 France. E-mail: charles.taieb@pierre- fabre.com (Received 29 July 2011; accepted 5 October 2011) Introduction Cosmetics are by no means a recent invention. As early as 3500 BC, women in ancient Egypt used age- fighting facial creams made from palm, coconut, and other plant-based oils mixed with aromatic herbs for fragrance. But it was not until thirty years ago that Professor Albert Kligman(1) coined the term “cos- meceuticals” that is now widely used, returning over 4.5 million Google hits and appearing in more than 500 publications on ScienceDirect. Around the same time, Kligman’s French con- temporary and highly accomplished pharmacist Pierre Fabre became the first European to officially practice what he called “dermo-cosmetics. ” Today, the com- pany that carries his name commands great respect in the worldwide dermo-cosmetic environment. Although neither figures in the dictionary, much less in current legal or regulatory documentation, “der- mo-cosmetics” and “cosmeceuticals” are commonly accepted terms that describe an important real-world concept: the creation of cosmetic and hygiene products in accordance with good pharmaceutical practice. In other words, based on this idea and the defini- tion proposed at the European Congress of Dermop- harmacy in Strasbourg on November 10, 1984, “dermo-cosmetics, ” or “cosmeceuticals, ” describes the field concerned with developing hygienic and cosmetological solutions to meet consumers’ needs through: 1) state-of-the-art products manufactured and tested in compliance with pharmaceutical stan- dards and techniques, and 2) endorsement or recom- mendation by expert healthcare professionals. Perhaps not by accident, that decade also wit- nessed a greater focus on “quality of life” and the invention of special diagnostic techniques for measur- ing patients’ sense of their own condition. The quality of life concept was and remains essentially founded on the WHO’s definition of “health” as “a state of Journal of Cosmetic and Laser Therapy, 2012; 14: 18–23 ISSN 1476-4172 print/ISSN 1476-4180 online © 2012 Informa UK, Ltd. DOI: 10.3109/14764172.2011.634420 ORIGINAL RESEARCH REPORTS CosmeceutiQoL: A tool for assessing dermo-cosmetic products’ impact on quality of life CHARLES TAIEB 1 , NORA RAHHALI 1 , VALENTIN MOINGEON 1 , NURIA PEREZ-CULLELL 2 & VINCENT SIBAUD 3 1 Public Health and Quality of Life, Pierre Fabre, Boulogne-Billancourt, France, 2 Eau Thermale Avène, France and 3 Dermatologyst, Institut Claudius Regaud-Toulouse, France Abstract Context and objective: The objective of assessing “quality of life” is to take better consideration of the patients’ perception of their own state of health by developing specific measurement tools. Paradoxically, there is no questionnaire evaluating the impact of such treatment on women’s quality of life. There was, therefore, a need for the creation of the Cosmeceu- tiQoL. Method: The questionnaire was developed using methodology in accordance with international standards in terms of quality of life. Results: The score of the CosmeceutiQoL was correlated to age. The more sensitive the skin is, the lower is the quality of life. For women who declared that their facial skin had started to sag, the quality of life was significantly lower. Deterioration of quality of life was also significantly observed in women who declared that they had age spots on the skin of their face and in women who said that their facial skin was dehydrated. We observed an altered CosmeceutiQoL score in women who declared that they had wrinkles, sagging skin or dark or brown spot. Discussion: The CosmeceutiQoL scale which is essentially based on the women’s point of view, is a valid, pertinent, and well accepted tool enabling the assessment of quality of life perceived through the skin. The more CosmeceutiQoL is altered, the more intense the signs of aging on the face, wrinkles, skin sagging, or dark or brown spots are observed, irrespective of the age. Key Words: cosmeceuticals, dermo-cosmetics, topical agents J Cosmet Laser Ther Downloaded from informahealthcare.com by Radboud Universiteit Nijmegen on 11/19/14 For personal use only.

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Page 1: CosmeceutiQoL: A tool for assessing dermo-cosmetic products’ impact on quality of life

Correspondence: Dr. Charles Taieb, Public Health and Quality of life Pierre, Fabre, 45 Place Abel Gance, Boulogne, 92100 France. E-mail: [email protected]

(Received 29 July 2011 ; accepted 5 October 2011 )

Introduction

Cosmetics are by no means a recent invention. As early as 3500 BC, women in ancient Egypt used age-fi ghting facial creams made from palm, coconut, and other plant-based oils mixed with aromatic herbs for fragrance. But it was not until thirty years ago that Professor Albert Kligman(1) coined the term “ cos-meceuticals ” that is now widely used, returning over 4.5 million Google hits and appearing in more than 500 publications on ScienceDirect.

Around the same time, Kligman ’ s French con-temporary and highly accomplished pharmacist Pierre Fabre became the fi rst European to offi cially practice what he called “ dermo-cosmetics. ” Today, the com-pany that carries his name commands great respect in the worldwide dermo-cosmetic environment.

Although neither fi gures in the dictionary, much less in current legal or regulatory documentation, “ der-mo-cosmetics ” and “ cosmeceuticals ” are commonly

accepted terms that describe an important real-world concept: the creation of cosmetic and hygiene products in accordance with good pharmaceutical practice.

In other words, based on this idea and the defi ni-tion proposed at the European Congress of Dermop-harmacy in Strasbourg on November 10, 1984, “ dermo-cosmetics, ” or “ cosmeceuticals, ” describes the fi eld concerned with developing hygienic and cosmetological solutions to meet consumers ’ needs through: 1) state-of-the-art products manufactured and tested in compliance with pharmaceutical stan-dards and techniques, and 2) endorsement or recom-mendation by expert healthcare professionals.

Perhaps not by accident, that decade also wit-nessed a greater focus on “ quality of life ” and the invention of special diagnostic techniques for measur-ing patients ’ sense of their own condition. The quality of life concept was and remains essentially founded on the WHO ’ s defi nition of “ health ” as “ a state of

Journal of Cosmetic and Laser Therapy, 2012; 14: 18–23

ISSN 1476-4172 print/ISSN 1476-4180 online © 2012 Informa UK, Ltd.DOI: 10.3109/14764172.2011.634420

ORIGINAL RESEARCH REPORTS

CosmeceutiQoL: A tool for assessing dermo-cosmetic products ’ impact on quality of life

CHARLES TAIEB 1 , NORA RAHHALI 1 , VALENTIN MOINGEON 1 , NURIA PEREZ-CULLELL 2 & VINCENT SIBAUD 3

1 Public Health and Quality of Life, Pierre Fabre, Boulogne-Billancourt, France, 2 Eau Thermale Av è ne, France and 3 Dermatologyst, Institut Claudius Regaud-Toulouse, France

Abstract Context and objective: The objective of assessing “ quality of life ” is to take better consideration of the patients ’ perception of their own state of health by developing specifi c measurement tools. Paradoxically, there is no questionnaire evaluating the impact of such treatment on women ’ s quality of life. There was, therefore, a need for the creation of the Cosmeceu-tiQoL. Method: The questionnaire was developed using methodology in accordance with international standards in terms of quality of life. Results: The score of the CosmeceutiQoL was correlated to age. The more sensitive the skin is, the lower is the quality of life. For women who declared that their facial skin had started to sag, the quality of life was signifi cantly lower. Deterioration of quality of life was also signifi cantly observed in women who declared that they had age spots on the skin of their face and in women who said that their facial skin was dehydrated. We observed an altered CosmeceutiQoL score in women who declared that they had wrinkles, sagging skin or dark or brown spot. Discussion: The CosmeceutiQoL scale which is essentially based on the women ’ s point of view, is a valid, pertinent, and well accepted tool enabling the assessment of quality of life perceived through the skin. The more CosmeceutiQoL is altered, the more intense the signs of aging on the face, wrinkles, skin sagging, or dark or brown spots are observed, irrespective of the age.

Key Words: cosmeceuticals, dermo-cosmetics , topical agents

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CosmeceutiQoL 19

complete physical, mental, and social well-being and not merely the absence of disease or infi rmity. ”

It thus comes as no surprise that dermatologists are becoming progressively more interested in assess-ing quality of life; as evidenced by the impressive number of new skin disorder questionnaires being used and developed every day.

There are three basic types of quality of life ques-tionnaire:

Generic scales (nondermatological) such as the –Short Form-12 Health Survey (SF-12), the SF-36 Short-Form(2), the Nottingham Health Profi le (NHP) (3), or the Sickness Impact Pro-fi le (SIP)(4). Generic dermatological scales such as the Der- –matology Life Quality Index (DLQI)(5) or Der-matology-Specifi c Quality of Life (DSQL)(6). Dermatosis-specifi c scales such as the Psoriasis –Disability Index (PDI)(7), the CADI(8) for acne, the NPQ10(9) for psoriasis of the nails, or HSFR14(10) for hand, foot, and mouth dis-ease occurring after chemotherapy.

For the generic questionnaires, a higher score equals better quality of life. In specifi c questionnaires, the higher the score, the more severely quality of life has been compromised. CosmeceutiQol falls into the lat-ter of these two categories.

Strangely, although dermo-cosmetics/cosmeceu-ticals is constantly evolving to provide solutions for patients of any age, there was until recently no ques-tionnaire capable of measuring the impact of these treatments on quality of life over time. This is why we considered it essential to create CosmeceutiQol when we did.

Objective

The aim of this study is to introduce and validate a scale designed specifi cally to assess the impact of dermo-cosmetic or “ cosmeceutical ” products on patients ’ quality of life. CosmeceutiQol is intended as a tool that can be used quickly and easily by either the patient or healthcare professional to obtain a one-dimensional assessment score within minutes.

Materials and methods

The questionnaire was developed according to a methodological process based on international qual-ity of life standards and consisting of four distinct but interdependent stages. First, we created an exhaustive list of survey items based on a wide range of prior studies, team members ’ experience, and patient input from a sample group of women ages 25 and up. This was followed by content analysis, then comprehension testing, which in turn led to us pair-ing down the item list for better ease of use. In stage

• Population typology• Review of the Literature

• Construction of a rationale• Review of available questionnaires

• Confirmation that no available questionnaire enables a response to concern

• Determination of concepts to measure patient interviews (face to face, focus group)

• Formulation of the verbatim• Creation of questions

• Beginning with verbatim justification of the pertinence of grouping the questions

• Choice of questionnaire format• Choice of response modalities

• Implementation of a pilot study to test the relevance and thoroughness of the questions

• Verification of a good understanding of the items, andpsychometric validation

VERSION 1

VERSION 2

FINAL VERSION

Figure 1. CosmeceutiQoL’s validation steps.

Table I. The CosmeceutiQoL score related to the age.

AgeWhole

popul ation25–44 45–64 Over 65

Proportions % 37.9 35.2 27.1 100 Mean 35.91 40.26 42.10 39.11 Std 14.03 13.94 14.27 14.29DCQoL Score Median 35.00 40.00 41.67 38.33 Min 5.00 0.00 5.00 0.00 Max 86.67 85.00 83.33 86.67p value � 0.0001

four, we set up the scoring system and established the questionnaire ’ s psychometric validity.

Of course, this general outline skims over the many important sub-steps involved in producing CosmeceutiQol version 1, version 2, and fi nally the defi nitive version illustrated in Figure 1.

Team members drew on their combined experi-ence to lay out a preliminary list of the top 24 con-cerns typically expressed by women in relation to their skin. The entire list was subjected to a rework-ing process. Numerous items were identifi ed as too similar and, therefore, grouped together, eventually resulting in a defi nitive list of 12 items. These were then reformulated as questions.

Each question was tested in a “ cognitive debrief-ing ” session intended to fl ag and resolve potential comprehension problems due to confusing word choice or obscure phrasing.

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20 C. Taieb et al.

Table II. The CosmeceutiQoL score related to the age and the skin sensitivity.

Age

Whole popul ation

25–44 45–64 Over 65

Skin sensitivity Skin sensitivity Skin sensitivity

Not/rather sensitive

Sensitive/Very sensitive

Not/rather sensitive

Sensitive/Very sensitive

Not/rather sensitive

Sensitive/Very sensitive

Proportions 154 224 169 180 152 117 996 Mean 32.94 38.09 38.05 42.21 40.14 44.86 39.14 Std 13.65 13.81 13.47 13.98 14.31 13.79 14.23DCQoL Score

Median 30.83 38.33 38.33 41.67 40.00 45.00 38.33 Min 5.00 8.33 5.00 0.00 5.00 11.67 0.00 Max 71.67 86.67 76.67 85.00 83.33 81.67 86.67p value 0.0004 0.0038 0.0069 � 0.0001

You would say that your skin is…

OverallNot

sensitiveRather

sensitive SensitiveVery

sensitiveI don’t know

DCQoL Score N 161 314 340 181 6 1002Mean 36.39 37.41 39.56 43.79 34.44 39.11Std 15.51 13.32 12.30 16.69 22.97 14.29Min 5.00 5.00 0.00 8.33 5.00 0.00Median 35.00 38.33 40.00 43.33 31.67 38.33Max 83.33 73.33 85.00 86.67 70.00 86.67

Kruskal-Wallis p-value � 0.0001

Figure 2.

Validation

The clarity and reliability of CosmeceutiQol were confi rmed over the course of three administrations (D0, D6, D15) to a sample group of 86 French women recruited by the Institut CSA Sant é (Health Institute of the French “ Survey Analysis Council ” ).

We also administered the SF12, a 12-item quality of life questionnaire that yields a score on two axes

(psychological and physical), as well as a vitality and well-being questionnaire.

Cronbach ’ s α coeffi cient(11) was 0.92, attesting to the scale ’ s excellent internal consistency.

Factor structure and principal component analy-sis (PCA) showed one component alone representing 55% of total variance. This result confi rmed the scale ’ s one-dimensionality. Statistical analysis thus

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CosmeceutiQoL 21

validated the successful design, as planned, of a single score covering all survey items.

We can also demonstrate CosmeceutiQol ’ s con-vergent validity by calculating a coeffi cient of correla-tion with the vitality/well-being questionnaire and SF12. The resulting correlation coeffi cients are sig-nifi cantly different from 0 at D0 (R � � 0.26, p � 0.0146), D6 (R � � 0.35, p � 0.0011), and D15 (R � � 0.30, p � 0.0077) (Figures 4 – 6). Likewise for the psychological dimension of SF12, in which p val-ues at D0, D6, and D15 are respectively p � 0.0068, p � 0.0049, and p � 0.0342.

Another cognitive debriefi ng(12) was carried out for the purpose of identifying and resolving potential comprehension problems due to poor translation or ambiguous phrasing. Translations were carefully engi-neered to express each question clearly in the target language without altering the meaning of the original. Interviews were conducted by native speakers with solid experience in cognitive testing techniques.

Interviewees were also native speakers and represen-tative of intended end users.

In conclusion, it has been adequately shown that this questionnaire is easy to understand and use.

Results

A representative sample group of 1002 French women aged 25 and over was recruited by the Insti-tut CSA Sant é using quotas for age, region of resi-dency, and socio-demographic profi le.

CosmeceutiQol was administered to this sample group. The CosmeceutiQol score correlates directly with age. Women aged 25 – 44 scored 35.91 � 14.03, those aged 45 – 64 scored 40.26 � 13.94, and those aged over 65 scored 42.1 � 14.27 (Table I).

Quality of life was observed to diminish in pro-portion to skin sensitivity. Subjects reporting not sensitive, rather sensitive, sensitive, and very sensitive

Figure 3. The CosmeceutiQoL score related to skin characteristics.

Table III. The CosmeceutiQoL score related to sun burns during childhood.

Sun burns during childhood

Whole populationRare Frequent

Number of people Mean Std

79638.5014.21

18041.5614.04

97639.0714.22

DCQoL Score Median

Min Max

38.33 41.67 38.330.00 8.33 0.00

86.67 85.00 86.67p value 0.0081

Table IV. The CosmeceutiQoL score related to the aging signs intensity.

Aging signs intensityWhole

populationLow High

Number of people Mean Std

87337.5413.39

10852.8112.90

98139.2314.16

DCQoL Score Median

Min Max

38.33 53.33 38.330.00 20.00 0.00

86.67 78.33 86.67p value � 0.0001 0 � 0.0001

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22 C. Taieb et al.

Cos

mec

eutiQ

oL a

t D0

10

20

20 30 40 50 60Vitality/well being score at D0

70 80 90 100

30

40

50

60

70

80

90

100

Figure 4. Linear regression-Relationship between the Cosme-ceutiQoL score and the Vitality/well being score at D0.

skin score respectively: 36.39 � 15.51, 37.41 � 13.32, 39.56 � 12.30, and 43.73 � 16.69 Figure (2). The difference was statistically signifi cant ( p � 0.001) and applied regardless of subject age (Table II).

Women reporting facial skin aging show signifi -cantly lower quality of life (42.66 � 13.56 versus 32.91 � 13.23 � p � 0.001). A signifi cant decrease in quality of life is also observed in women who report color spots or dehydrated skin on the face (44.31 � 14.4 versus 36.89 � 13.87 for the former and 46.86 � 13.07 versus 36.20 � 13.63 for the

latter) (Figure 3). CosmeceutiQol also shows (sig-nifi cantly) reduced quality of life in subjects report-ing frequent childhood sunburn (41.56 � 14.04 versus 38.5 � 14.21 � p � 0.008) (Table III).

Lastly, CosmeceutiQol refl ects degraded quality of life (score around 40) in women reporting wrin-kles (41.26 � 13.9), skin sagging (42.66 � 13.56), or pigmentation marks (44.31 � 14.4).

Regardless of age category, the CosmeceutiQol score increases in correlation with the perceived intensity of aging signs on the face (Tables IV and V). For women reporting wrinkled or rough skin on

Table V. The CosmeceutiQoL score related to the age and the aging signs intensity.

Age

Whole population

25–44 45–64 Over 65

Aging signs intensity Aging signs intensity Aging signs intensity

Low High Low High Low High

Number of people Mean Std

35735.7713.70

1150.4514.98

31638.6313.16

3455.4412.20

20038.9912.89

6351.8012.87

98139.2314.16

DCQoL ScoreMedian

Min Max

35.00 55.00 38.33 56.67 39.17 51.67 38.335.00 20.00 0.00 35.00 5.00 25.00 0.00

86.67 65.00 85.00 78.33 81.67 78.33 86.67p value 0.0019 � 0.0001 � 0.0001 � 0.0001

030 40 50 60 70

Vitality/well being score at D680 90 100

10

20

30

40

50

60

Cos

mec

eutiQ

oL a

t D6

Figure 5. Linear regression-Relationship between the Cosme-ceutiQoL score and the Vitality/well being score at D6.

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CosmeceutiQoL 23

0

30 40 50 60 70 80 90 100

10

20

30

40

50

Cos

mec

eutiQ

oL a

t D15

Vitality/well being score at D15

Figure 6. Linear regression-Relationship between the Cosmeceuti-QoL score and the Vitality/well being score at D15.

the face, wrinkles, skin sagging, and pigmentation marks – all regardless of age category.

CosmeceutiQol is available on request in French or English. Contact the authors for more information.

Confl ict of interest

There are no confl icts of interest.

References

Amy E. Newburger. Cosmeceuticals: Myths and misconcep-1. tions. Clin Dermatol. 2009;27:446 – 452. Ware JE, Sherbourne CD. The MOS 36-ItemShort-Form 2. Health Survey (SF-36).1. Conceptual framework and item selection. Med Care. 1992;30:437 – 483. Hunt SM, McKenna SP, McEwen J, et al. The Nottingham 3. health Profi le: Subjective health status and medical consulta-tions. Soc Sci Med. 1981;15A:221 – 229. Bergner M, Bobbit RA, Carter WB, Gilson BS. The Sickness 4. Impact Profi le: Development and fi nal revision of a health status measure. Med Care. 1981;19:787 – 805. Finlay AY, Khan GK. Dermatology LifeQuality Index 5. (DLQI): A simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19:210 – 216. Anderson R, Rajagopalan R. Responsiveness of the Derma-6. tology-specifi c Quality of Life (DSQL) instrument to treat-ment for acne vulgaris in a placebo-controlled clinical trial. Qual Life Res. 1998;7(8):723 – 734. Finlay AY, Kelly SE. Psoriasis-an index of disability. Clin Exp 7. Dermatol. 1987;12:8 – 11. Rolka H, Krajewska-Kulak E, Baranowska A, Jankowiak B, 8. Van Damme-Ostapowicz K, Bielemuk A, Szyszko-Perlowska A, Klimaszewska K. Application of CADI scale in the assess-ment of quality of life in patients with acne vulgaris. Derma-tologia Kliniczna 2010,12(2):95 – 98. Ortonne JP, Baran R, Corvest M, Schmitt C, Voisard JJ, 9. et al. Development and validation of nail psoriasis quality of life scale (NPQ10). J Eur Acad Dermatol Venereol. 2010;24(1):22 – 27. Sibaud V, Dalenc F, Chevreau C, Roché H, Delord JP, Mourey 10. L, Lacaze JL, Rahhali N, Taieb C. HFS-14, a specifi c quality of life scale developed for patients suffering from hand-foot syn-drome. Melanoma Res. June 2011;21:p e12–e13. Spiliotopoulou G. Reliability reconsidered: Cronbach’s alpha 11. and paediatric assessment in occupational therapy. Aust Occup Ther J. 2009;56(3):150 – 155. Principles of Good Practice for the Translation and Cul-12. tural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation published in Value in Health, Vol. 8, Issue 2, 2005 pp 95 – 104. http://www.ispor.org/workpaper/research_practices/PROTranslation_Adaptation.pdf.

the face, CosmeceutiQol yielded scores of, respec-tively, 50.73 � 13.74 (versus 37.46 � 13.58), and 50.17 � 16.40 (versus 38.41 � 13.86).

Discussion

The CosmeceutiQol scale is based essentially on the subject ’ s point of view. It is a valid, pertinent, highly acceptable tool for assessing quality of life as per-ceived in relation to the skin.

All objectives were met: the questionnaire is self-administrated and simple to use for easy distribution, it is one-dimensional for single scoring, and it is straightforward for maximum applicability.

CosmeceutiQol was validated according to cur-rently accepted cultural and linguistic criteria.

CosmeceutiQol yields a score that increases in direct correlation with the intensity of aging signs on

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