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Original Research: The effect of a topically-applied cosmetic oil formulation on striae distensae The effect of a topically-applied cosmetic oil formulation on striae distensae Summers B, PhD
Lategan M, Dip Cos Sci Photobiology Laboratory, Medunsa Campus, University of Limpopo Correspondence to: Dr B Summers, e-mail: bsumm@ul.ac.za
Keywords: stretch marks; striae distensae; cosmetic; topical application
Abstract
Background: Stretch marks or striae distensae are tears in the dermis, above which the epidermis remains intact. Striae result from rapid
expansion of the underlying tissue, e.g. during puberty, pregnancy or rapid weight gain. The prevalence of striae is high (up to 80% in most
populations). Many of the successful treatment modalities for striae (laser, surgery, prescription-only medication) entail high costs, often with the
involvement of private medical practitioners. The objective of the study was to investigate the effect of a topical application (Bio-Oil™) on striae in
20 healthy Caucasian women. The study was performed according to standard good clinical practice guidelines.
Methods: The study was conducted among 20 healthy Caucasian women with bilateral abdominal striae. The women used the test product on one
side of their abdomen twice a day for 12 weeks, and their normal moisturising routine on the other side. Assessment methods were: 1) subjective
visual self-assessment, using both the Patient and Observer Scar Assessment Scale (POSAS) and a directed difference (i.e. comparison of sides), and
2) objective laboratory visual assessment (blinded) using the same scales.
Results: The subjective visual self-assessment yielded statistical significance at four weeks in terms of improvement of the treated striae when
compared to the untreated sites, using both the POSAS and directed difference. Objective laboratory visual assessment, using the POSAS and
directed difference, showed a statistical improvement on the treated side from week 2 onwards.
Conclusions: The test product (Bio-Oil™) significantly improved the appearance of striae on the treated side of the abdomen as assessed by both
subjective and objective assessments. This study has shown that it is possible to improve the appearance of striae with the topical application of a
relatively low-cost, non-medicinal product.
This article has been peer reviewed.
SA Fam Pract 2009;51(4):332-336
hormonal changes. It is estimated that 50% to 90% of women develop some stretch marks during pregnancy.1,3 The prevalence is higher in Stretch marks or striae distensae are tears in the dermis, above which women who are already obese prior to pregnancy.3 the epidermis remains intact.1 Stretch marks are referred to as striae cutis distensae, striae gravidarum and by many other terms.1 Throughout The subject of the prevention of striae gravidarum formation is this paper, the collective term striae will be used.
controversial. Many cosmetic products claim to help prevent the formation of stretch marks, but the ethical issues related to the conduct Striae appear as elliptical erythematous or blanched areas on the of clinical studies on pregnant women hinder objective assessment. skin. Striae may merge to form an interwoven pattern on the affected area. The internal reflectance of the damaged areas often produces a Only one published randomised controlled study could be identified which pearlised appearance. Striae often feel softer and more pliable than the claimed to test whether cosmetic creams prevent the development of surrounding skin. stretch marks.4 This study found that only 34% of the group that used a daily application of a cream containing Centella asiatica extract, vitamin Striae result from rapid expansion of the underlying tissue, e.g. during E and collagen-elastin hydrolysates developed striae, as opposed to 56% puberty, pregnancy or rapid weight gain.1 They may also result from in the control group. In women with a history of striae during puberty, a weakening of the dermal tissue. Striae are commonly found on the active cream induced a significant absolute prevention in 89% of the the abdomen (especially near the umbilicus), breasts, upper arms, cases, whereas all the women in the placebo group developed striae.4 underarms, thighs, hips and buttocks.1 The prevalence of striae is high Another study, with an untreated control, examined a cream which (up to 80% in most populations).2,3 contained vitamin E, panthenol, hyaluronic acid, elastin and menthol. Use Pregnant women are at particular risk of developing stretch marks (striae of the cream was associated with fewer stretch marks during pregnancy gravidarum) due to the combination of rapid abdominal growth and versus no treatment.5 SA Fam Pract 2009 Original Research: The effect of a topically-applied cosmetic oil formulation on striae distensae Original Research: The effect of a topically-applied cosmetic oil formulation on striae distensae Treatments that have been used to improve the appearance of existing stretch marks include laser treatments, laser dermabrasion, topical retinoids and exfoliation.6 Fractional laser resurfacing uses scattered pulses of light on small areas of the lesion, over several treatments. The • In good health pulsed laser causes micro-damage and micro-repair, hence the body • Willing to sign informed consent and attend all appointments responds to the treatment by producing new collagen and epithelium. • Having appropriate bilateral striae The procedure improved both the texture and appearance of mature, white striae in skin phototypes I to IV.7 Note: as this was an exploratory study, no limit was placed on the age or
appearance of the striae.
Tretinoin (0.1%) has been shown to improve the appearance of striae over six months when compared with a vehicle-only group.9,10 Alpha • Breast-feeding or pregnant hydroxy acids (e.g. glycolic acid 15–20%) have also been patented to treat striae.11 Dermabrasion with sand and/or exfoliation with • Currently taking or applying antihistamines, anti-inflammatories, corticosteroids or other medication that may affect skin reactions trichloroacetic acid (15–20%) has also been shown to be effective for improving the appearance of striae in all skin types.12,13 Perhaps the • Suffering from diabetes, circulatory problems, malnutrition or other conditions that may adversely affect healing processes most drastic approach to the removal of striae is that of surgical removal of the affected areas of skin, e.g. through a "tummy tuck".1 Randomisation and assessor blinding
Many of the above modalities entail high-cost specialist treatments, often The product was allocated randomly to either the right or left side of with the involvement of private medical practitioners. Such treatments the panellist's abdomen. Allocation was in such a way that 10 panellists are not always accessible or affordable to those who have problematic applied the product to the left side and 10 to the right. The opposite side striae. Hence there is a huge market for over-the-counter products that of the abdomen was the control site.
claim to prevent or improve striae. Few studies exist to support the claims The assessors were blinded as to the product-treated side. The made by these products, and most of those that do are not published in randomisation code was based on the study number of the panellist and peer-reviewed media.14 was only broken at the end of the study, once the data analysis had been completed.
In South Africa, an oil-based cosmetic formulation (Bio-Oil™) has been produced and marketed since 1987.15 It is also marketed in 17 other Study panel
countries. A large body of anecdotal evidence regarding product efficacy Thirty-two potential panellists attended the study briefing. The panellists developed over the years. Consumers found that the product improved were briefed orally and given the study calendar and instructions. They the appearance of uneven skin pigmentation, striae and scars. In early completed a health questionnaire and informed consent form for study 2005 we were approached to design and conduct objective clinical purposes at the start of the study.
studies on the product to test its efficacy for those skin conditions. Immediately after the briefing and form completion, a visual assessment Our laboratory has been involved with the objective assessment of the was conducted to determine qualification for the study (to ensure that safety and efficacy of sunscreens and cosmetic products since 1989. the proposed test sites had suitable striae). Panellists with bilateral This was the first study that we conducted on striae. Striae are in fact abdominal striae were identified so that a half-abdomen study design scars.13,16 Consequently, scar assessment methods are appropriate in could be adopted. the study of striae. A protocol was developed in conjunction with the Panellist health questionnaires and consent forms were reviewed by the Department of Plastic and Reconstructive Surgery on the Medunsa study investigator for eligibility and completeness. Queries, omissions or Campus of the University of Limpopo.
potential problems on the forms were "flagged" for clarification at the This paper presents the findings of a 12-week study on striae, based on baseline visit.
the above protocol and conducted at the Photobiology Laboratory, School The 20 most suitable potential panellists were included in the study. of Pharmacy, Medunsa Campus, University of Limpopo, South Africa.
Products and application
Bio-Oil™ contains a mixture of potential actives in a mineral oil, isopropyl myristate and cetearyl ethylhexanoate base. The actives in the product that are known to play a role in skin improvement include retinyl The objective of the study was to investigate the effect of 12 weeks palmitate, tocopherol acetate and glycine soja. In addition, the properties of application of topically applied cosmetic oil (Bio-Oil™) on cutaneous of the following actives could also play a role in the improvements striae, under randomised, controlled, observer-blinded conditions.
seen – Lavandula augustifolia (astringent and antiseptic), Rosmarinus officinalis (soothing and antiseptic), Calendula officinalis (regenerative), Sample size
and bisabolol (anti-inflammatory).
Twenty healthy Caucasians with bilateral striae were included in the The target application quantity was 2 mg/cm2 of product, which is a study (see below). The sample size was determined on the basis of the standard application quantity in similar skin studies. Measurement of size of the expected difference between the test and control sites and the application dose was performed using a 1 ml syringe. For some also on economics.
panellists this quantity proved cosmetically unacceptable (i.e. excessive), SA Fam Pract 2009 Original Research: The effect of a topically-applied cosmetic oil formulation on striae distensae Original Research: The effect of a topically-applied cosmetic oil formulation on striae distensae hence the panellists were allowed to apply as much as was acceptable. A simple directed difference was used to assess the relative condition of Application quantities were monitored through product weight. the test sites in terms of whether the right site was much worse, worse, the same, better or much better than the left site. The panellists were instructed to apply the test product in the morning and at night, after their normal hygiene routines. They otherwise followed Visual evaluation – subjective
their normal cleansing and moisturising routine, except that the test A subjective evaluation was performed by each panellist under the product was used as a substitute for their normal moisturiser on the supervision of a study assistant, using the subjective POSAS and directed treated side of the abdomen. Hence, whilst the assessors were blinded as to the identity of the treatment sites, the panellists were aware which side was treated with the test product and which had undergone their regular moisturising routine.
The visual data were discrete data, therefore a non-parametric statistical The product was issued to the panellists immediately after the baseline test was used. The Wilcoxon Sign Rank Test was applied to the scores. assessment had been performed. The panellists were instructed how In addition, the number of panellists in each group who had improved, to apply to product and the initial application was performed under the remained the same or worsened was calculated.
supervision of a staff member not involved in the assessment. Supervised All data were recorded manually and then entered into an Excel application was performed on the first two days of the study (Thursday spreadsheet. Proofreading was performed after data entry. After sorting and Friday), then on the following Monday, and then at weekly intervals the data according to the treatment, statistical analysis was performed. for the first four weeks and thereafter every two weeks. After the baseline assessment, the study continued for 12 weeks. The The product was smoothed gently onto the skin and allowed to be data for weeks 0, 4, 8 and 12 are presented below.
absorbed, with no massage. As massage can play a role in the condition of skin, the panellists were instructed to apply the test product as they would apply their normal moisturiser, hence the role of massage was The study was conducted in accordance with the ‘Guidelines for good practice in the conduct of clinical trials in human participants in South Africa'.17 These guidelines are comprehensive and are based on the ICH Product application continued twice daily at home. An application diary Tripartite Guidelines for Good Clinical Practice (1997) and the Declaration was issued to the panellists to record the time of each application.
of Helsinki (2000).17 The product containers were weighed at the beginning and end of the Permission to conduct the study was granted under the protocol approval study to monitor product use.
for project MC 81/2005 of the Medunsa Campus Research and Ethics Committee of the University of Limpopo.
Assessments were conducted by study staff with several years experience in skin assessment.
The assessment of the striae was carried out by means of a recognised One panellist (number 7) was discharged after week 8 for protocol violation. scar assessment grading scale, the Patient and Observer Scar This panellist had abdominal liposuction between weeks 8 and 12.
Assessment Scale (POSAS).16 A directed difference of relative striae condition was also performed. Product application quantities varied between the panellists, but were relatively consistent on the two sides of any given panellist. An average A detailed description of the assessments follows: of 2.75 g of product was applied per day (or 1.375 g per application). Visual evaluation – objective and blinded
Hence, if the average application area was 900 cm2, that equates to an The POSAS Scar Scale is intended to be used by adding the individual application quantity of approximately 1.5 mg/cm2. scores from the scale's components and obtaining a total. Any improvement in the scar or stria will reflect as a lower total.
There were no adverse reactions to the test product or to the panel ists' The POSAS covers five parameters (vascularisation, pigmentation, normal products.
thickness, relief, pliability), each graded on a scale of 1 to 10. The higher Visual evaluation – objective POSAS
the number, the worse the stria or scar (i.e. a potential total of 50 for the worst possible stria). The objective POSAS showed no difference between the treated and untreated sides at week 0 (see Table I). Overall there was a relative The change in parameters was calculated as follows: improvement on the treated side, with significance from week 4 (p = 0.5).
Change in parameter (delta) Visual evaluation – objective directed difference
= (score of untreated striae at time t - score of treated striae at time t) The directed difference was considered by the assessors to be the - (score of untreated striae at time baseline - score of treated striae at simplest as well as the most reliable method of comparison. The directed baseline) Equation 1 difference indicated an improvement on the treated side (see Table II). Using Equation 1, a positive value reflects an improvement in the striae The improvement was statistically significant (p ≤ 0.05) at weeks 4, 8 on the treated side, over time, relative to the untreated side.
and 12 using the Wilcoxon Sign Rank Test.
SA Fam Pract 2009 Original Research: The effect of a topically-applied cosmetic oil formulation on striae distensae Original Research: The effect of a topically-applied cosmetic oil formulation on striae distensae Table I: Objective POSAS score summary
Untreated
Both visually and instrumentally, striae are very difficult to assess.18 Their Number in
appearance is often pearly, and it changes depending on the angle of light. Striae vary considerably in size and colour, from small white pearly ellipses to large, contiguous pink/red dappled "zebra-stripe" lines.
A 12-week study was implemented in order to al ow sufficient time for the effect of the product to become apparent.
The scores on the POSAS cover a relatively wide range, from 1 to 10. Note: See Equation 1 and Discussion for rationale for using difference between scores rather than raw scores Hence it is difficult to achieve consistency on the scale from week to week (e.g. the same parameter scored as a 6 in one assessment week Table II: Directed difference summary
may be rated as a 5 at the following assessment). Using Equation 1 Number of panellists
allows for any drift in assessment to be eliminated, as assessment is narrowed down to a relative difference between the two sites.
site better site worse difference
Both the subjective assessment grades peaked at week 8. This phenomenon is difficult to explain, even with the loss of one panellist between weeks 8 and 12. The following graph summarises the improvements, scored on the POSAS scale, as perceived by the panellists (subjective) and the blinded assessors (objective): Visual evaluation – subjective POSAS
Figure 1: Mean improvement in scores of treated sides over untreated sides:
The subjective evaluation showed a perceived improvement from POSAS objective (expert assessor) and subjective (panellists)
baseline that was statistically significant from four weeks onwards (a lower score equates to a better condition) (see Table III).
Objective POSAS scoreSubjective POSAS Table III: POSAS subjective score summary
Mean of total
Untreated
Number in
POSAS score
Difference p value
Visual evaluation – subjective directed difference
The panellists assessed the striae in overall terms by completing the directed difference assessment (see Table IV). These scores confirmed From Figure 1, it is interesting to note that the subjective assessment the POSAS totals in that they showed a perceived improvement on the of the improvement of the treated side, relative to the untreated side, was considerably greater than that of the objective assessment. The difference could be due to one of two factors: Table IV: Directed difference (subjective) summary
1. The panellist's knowledge of which side was treated may have led to a positive bias. However, the panellists were predominantly experienced participants in clinical studies. Many were professional Number in
untreated
treated score score (mean Difference p value
women with either postgraduate or administrative qualifications. As (mean diff)
such, their opinions should be relatively objective and critical.
2. The more likely explanation is that the panellists had a completely different visual perspective of the striae from that of the assessors. The assessor was seated in front of the panellists and the panellists were viewed frontally, with the assessor swivelling the panellists to obtain a balanced view. The panellists, on the other hand, were in a standing position and observed their abdomens from above, hence their angle of observation was relatively consistent for each side. It may have been easier for the panellists to make a direct side-by-side comparison than it was for the assessor.
SA Fam Pract 2009 Original Research: The effect of a topically-applied cosmetic oil formulation on striae distensae Original Research: The effect of a topically-applied cosmetic oil formulation on striae distensae The simple, directed difference measures were the most effective comparators.
Bio-Oil™ significantly improved the appearance of striae on the product-treated side of the abdomen, as assessed by both subjective (POSAS and directed difference) and objective (POSAS and directed difference) means. The improvements were observed after four weeks of treatment and peaked at six to eight weeks (p = 0.05).
This study has shown that it is possible to improve the appearance of striae through the topical application of a relatively low-cost, non-medicinal product.
This study was funded by a grant from Union-Swiss Pty Ltd, South Africa.
The authors acknowledge the co-operation of Drs Stefan Rawlings and Jan van Heerden of the Department of Plastic and Reconstructive Surgery, Medunsa Campus, University of Limpopo, for their review of and comments on the protocol. References
1. Wikipedia. Stretch marks. Available from http://en.wikipedia.org/wiki/Stretch_marks (Accessed
2. Cho S, Park ES, Lee DH, Li K, Chung JH. Clinical features and risk factors for striae distensae in Korean adolescents. Journal of the European Academy of Dermatology and Venereology 2006;20(9):1108–13. 3. Atwal GSS, Manku LK, Griffiths CEM, Polson DW. Striae gravidarum in primiparae. British Journal of 4. Mallol J, Belda MA, Costa D, Noval A, Sola M. Prophylaxis of striae gavidarum with a topical formulation. A double blind trial. International Journal of Cosmetic Science 1991;13(1):51–7. 5. Young GL, Jewell D. Creams for preventing stretch marks in pregnancy. Cochrane Database of Systematic Reviews 1996, Issue 2. Art. No.: CD000066.
6. Suh D-H, Chang K-Y, Son H-C, Ryu J-H, Lee S-J, Song K-Y. Radiofrequency and 585-nm pulsed dye laser treatment of striae distensae: a report of 37 Asian patients. Dermatologic Surgery 2007;33(1):29–34. 7. Macedo O, Bussade M, Guerreiro V, Salgado A, Saviolli J, Secco L. Fractional photothermolysis for the treatment of striae distensae. Abstact. 5th World Congress of the International Academy of Cosmetic Dermatology, Melbourne, Australia, 9–13 December 2006.
8. Flynn TC, Coleman WP. Topical revitalization of body skin. Journal of the European Academy of Dermatology and Venereology 2000;14(4):280–4.
9. Kang S, Kim J, Griffiths CE, et al. Topical tretinoin (retinoic acid) improves early stretch marks. Arch Dermatol 1996;132(5):519–26. 10. US patent. Methods of preventing and reducing the size of striae distensae lesions. Available from http:// 11. US patent. Method of applying alpha hydroxy acids for treating striae distensae. Available from http:// 12. Adatto MA, Deprez P. Striae treated with a novel combination of sand abrasion and a patent mixture containing 15% trichloroacetic acid followed by 24 hrs of a patent cream under plastic occlusion. J Cosmet Dermatol 2003;2(2):61–7.
13. Alaiti S, Obagi ZE. Striae distensae. Available from http://www.emedicine.com/derm/topic406.htm 14. Moy LS, Lesser T. Striae cream with Regenetrol complex™ demonstrates efficacy on stretch marks: a double-blind controlled study. Received from authors. Available on request from Moy Skincare via http://www.nomorestretchmark.com/contact_us.php? 15. Knowlton J. Personal communication, john@cosmeticsolutions and http://www.union-swiss.co.za/index.
16. Draaijers LJ, Tempelman FRH, Botman YAM, et al. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plastics and Reconstructive Surgery 2004;113(7):1960–5.
17. Department of Health, Government of South Africa. Guidelines for good practice in the conduct of clinical trials in human participants in South Africa; 2000. Available from http://www.doh.gov.za/docs/policy/trials/trials_01.htm (Accessed 29/12/2007).
18. Hermanns JF, Pierard GE. High resolution epiluminescence colorimetry of striae distensae. J Eur Acad Dermatol Venereol 2006;20(3):282–7.
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Migraine patient handout

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