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Multi-Center Randomized Clinical Study of The Effects of Natural Oils on Xerosis and Skin Barrier Properties

September 2018
SKIN The Journal of Cutaneous Medicine 2(5)

DOI:10.25251/2.5.1

License
CC BY 4.0

Authors:

Objective: To compare the effect of natural oils and white petrolatum on skin barrier function in patients with xerosis.Design, Setting, and Participants: Randomized, open label, comparison pilot study (NCT03093597).Interventions: Participants were randomized to apply 1 of 4 moisturizers to assigned treatment areas twice daily for 2 weeks. Clinical dry skin score, stratum corneum hydration, and transepidermal water loss (TEWL) were assessed at baseline, 1 week, and 2 weeks.Results: Thirty-two participants completed the study. Neither TEWL nor hydration were statistically different among the moisturizers at each visit. All four moisturizers led to significant initial increase in TEWL at week 1 (p < 0.05) with an associated increase in hydration for coconut oil, jojoba oil, and white petrolatum. All four moisturizers led to significant increase in hydration by week 2 (p < 0.01). The preferred moisturizers were almond oil and coconut oil, which were most “liked” by 38% and 31% of the participants, respectively. The least preferred moisturizer was white petrolatum. Conclusions: Almond oil, jojoba oil, and coconut oil significantly increased hydration after 2 weeks, and are as effective as white petrolatum as daily moisturizers for xerosis. The participants preferred natural oils to white petrolatum, implying that these moisturizer options may improve patient compliance.

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SKIN

September 2018 Volume 2 Issue 5

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ORIGINAL RESEARCH

Pilot Study on the Effects of Natural Oils on Skin Barrier Function in Xerotic

Skin

Alexandra R. Vaughn MDa,b, Mimi Nguyen BSa, Melody Maarouf MHSc, Melissa R. Van Skiver

BAd, Khiem A. Tran PhDc, Iryna Rybaka, Raja K. Sivamani MD MS APa,e,f, Vivian Y. Shi MDd

aDepartment of Dermatology, University of California – Davis, Sacramento, CA

bDrexel University College of Medicine, Philadelphia, PA

cUniversity of Arizona College of Medicine, Tucson, AZ

dDepartment of Medicine, Division of Dermatology, University of Arizona, Tucson, AZ

eDepartment of Biological Sciences, California State University, Sacramento, CA

fPacific Skin Institute, Sacramento, CA

Xerosis is associated with disrupted stratum

corneum (SC) integrity and skin barrier

function (SBF), leading to decreased

hydration and transepidermal water loss

(TEWL).1 There is a growing trend towards

using alternative natural moisturizers, as

barrier repair emollients are expensive and

often contain potential irritants and allergens.

White petrolatum (WP) is a commonly

recommended moisturizer, but compliance is

often limited by its greasiness.

INTRODUCTION

Objective: To compare the effect of natural oils and white petrolatum on skin barrier function

in patients with xerosis.

Design, Setting, and Participants: Randomized, open label, comparison pilot study

(NCT03093597).

Interventions: Participants were randomized to apply 1 of 4 moisturizers to assigned

treatment areas twice daily for 2 weeks. Clinical dry skin score, stratum corneum hydration,

and transepidermal water loss (TEWL) were assessed at baseline, 1 week, and 2 weeks.

Results: Thirty-two participants completed the study. Neither TEWL nor hydration were

statistically different among the moisturizers at each visit. All four moisturizers led to

significant initial increase in TEWL at week 1 (p < 0.05) with an associated increase in

hydration for coconut oil, jojoba oil, and white petrolatum. All four moisturizers led to significant

increase in hydration by week 2 (p < 0.01). The preferred moisturizers were almond oil and

coconut oil, which were most “liked” by 38% and 31% of the participants, respectively. The

least preferred moisturizer was white petrolatum.

Conclusions: Almond oil, jojoba oil, and coconut oil significantly increased hydration after 2

weeks, and are as effective as white petrolatum as daily moisturizers for xerosis. The

participants preferred natural oils to white petrolatum, implying that these moisturizer options

may improve patient compliance.

ABSTRACT

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The fatty acid composition of natural oils

contributes to their unique characteristics and

effects on the skin; for instance olive oil is

higher in oleic acid and appears to disrupt the

skin barrier, while oils higher in linoleic acid

appear to improve the skin barrier.2 Coconut

oil (CO) is comparable to mineral oil at

improving hydration without altering TEWL

and has anti-microbial properties.3 Jojoba oil

(JO) can decrease TEWL and enhance SC

moisturization.4 Almond oil (AO) is rich in

antioxidants such as omega and linoleic fatty

acids and vitamin E and has occlusive

properties comparable to mineral oil.5

There is no head-to-head comparison

between natural oils and WP for

moisturization. This randomized, open label,

comparison pilot study aims to compare the

ability of natural oils (AO, CO, and JO) and

WP to improve xerosis and SBF. This clinical

trial was registered on clinicaltrials.gov

(NCT03093597) prior to participant

enrollment.

Nineteen subjects from University of

California, Davis (UCD) in Sacramento and

eighteen subjects from University of Arizona

(AZ) in Tucson participated in this study

(mean age 59.5 years old, range 24-85

years). The study was approved by the

Institutional Review Board at both sites, and

time period for recruitment and follow-up was

January 18, 2017 through July 31, 2017.

Baseline TEWL and hydration were not

significantly different.

Subjects were supplied with pre-measured

certified organic CO (Nature’s Bounty®), JO

(The Jojoba Company), AO (Mountain Rose

Herbs), and WP. Each of the four

moisturizers was pre-randomized in blinded

envelopes to one of four application areas on

the right and left forearms prior to

recruitment. The subjects applied 0.1ml of

each moisturizer twice daily to the assigned

area for two weeks. TEWL and hydration

were measured at baseline, 1 week and 2

weeks using Vapometer and

MoistureMeterSC (Delfin Technologies),

respectively. Xerosis was graded using the

Dry Skin Scale (DSS)6, and UCD participants

were asked to complete a survey regarding

moisturizer preferences at the final visit.

Intra- and intergroup evaluations were

performed using paired t-test and a

Bonferroni correction was implemented to

reduce type I error when comparing

moisturizers.

Four subjects were lost to follow-up after the

baseline visit, one subject dropped out after

week 1 due to scheduling conflicts, and thirty-

two subjects completed the week 2 study

visit. Outcome measurements are displayed

in Figure 1. Neither the TEWL nor the

hydration were statistically different among

moisturizers at each visit. All moisturizers

significantly increased TEWL at week 1 (p <

0.05) compared to baseline, and only JO and

CO persisted to have a significant increase in

TEWL at week 2 (p < 0.05).

All four moisturizers significantly increased in

hydration by week 2 (p < 0.01). There were

no significant differences in outcome

measurements when data was analyzed

separately for each study site. Thirteen

participants at the UCD study site completed

a survey, and AO was most “liked” (38%),

followed by CO (31%). WP was “least liked”

(62%). No adverse events were reported.

METHODS

RESULTS

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Figure 1. Changes in skin barrier biophysical

properties with moisturizer use. Transepidermal water

loss (A) and hydration (B) values at week 1 and week

2 visits are normalized to the measurements at the

baseline visit. Error bars represent SEM. n=32. * =

p<0.01.

AO, JO, and CO can be as effective as WP in

improving SBF in patients with xerosis.

Limitations of this study include:

assessments localized to forearms, short

study period, and relatively low baseline DSS

in study subjects. Natural oils can be

comparable alternatives to commercially

available emollients and are preferred over

WP, which may improve patient compliance.

Antimicrobial, antioxidant, and anti-

inflammatory properties are additional

benefits of natural oils. Larger randomized

trails that evaluate the benefit of additional

natural oils are needed, especially in

inflammatory dermatoses associated with

barrier defects, such as atopic dermatitis and

psoriasis.

Conflict of Interest Disclosures: RKS serves as a

scientific advisor to Dermveda and serves as a

consultant to Dermala and Burt’s Bees. VYS has

stock options in Dermveda, serves as a consultant for

Menlo Therapeutics, Sanofi Genzyme, Burt’s Bees,

and the National Eczema Association, and has

received research funding from Skin Actives

Scientific.

Funding: ARV received a medical student research

grant from Banyan Botanicals. The funding source had

no role in data analysis or the decision for publication.

Corresponding Author:

Vivian Y. Shi, MD

Department of Medicine, Dermatology Division

University of Arizona

vshi@email.arizona.edu

References:

1. Kezic S, Novak N, Jakasa I, Jungersted

JM, Simon M, Brandner JM, et al. Skin

barrier in atopic dermatitis. Frontiers

in bioscience (Landmark edition).

2014;19:542-56.

2. Vaughn AR, Clark AK, Sivamani RK, Shi

VY. Natural Oils for Skin-Barrier Repair:

Ancient Compounds Now Backed by

Modern Science. Am J Clin Dermatol.

2018;19(1):103-17.

3. Agero AL, Verallo-Rowell VM. A

randomized double-blind controlled

trial comparing extra virgin coconut oil

with mineral oil as a moisturizer for

mild to moderate xerosis. Dermatitis :

contact, atopic, occupational, drug.

2004;15(3):109-16.

4. Meyer J, Marshall B, Gacula M, Jr.,

Rheins L. Evaluation of additive effects

of hydrolyzed jojoba (Simmondsia

chinensis) esters and glycerol: a

preliminary study. Journal of cosmetic

dermatology. 2008;7(4):268-74.

5. Ranzato E, Martinotti S, Burlando B.

Wound healing properties of jojoba

liquid wax: an in vitro study. Journal of

DISCUSSION

SKIN

September 2018 Volume 2 Issue 5

272

ethnopharmacology. 2011;134(2):443-

6. Serup J. EEMCO guidance for the

assessment of dry skin (xerosis) and

ichthyosis: clinical scoring systems.

Skin research and technology: official

journal of International Society for

Bioengineering and the Skin (ISBS)

[and] International Society for Digital

Imaging of Skin (ISDIS) [and]

International Society for Skin Imaging

(ISSI). 1995;1(3):109-14.

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TRENDS FOOD SCI TECH

Background The convergence of food and cosmetics in the beauty industry is a major trend in the recent years, gaining an enormous importance on consumer habits including the diet, the nutritional supplement intake and food-based cosmetics. Scope and approach An overview about the concept of nutricosmetics is here presented, and how food and skin convergence trends the cosmetic industry. Examples of recently developed products are given. Key findings Food ingredients are being included in cosmetics and other personal care products with the aim of bringing into cosmetic products certain benefits of food ingredients. Moreover, due to the recommendation of the circular economy implementation, an approach to economic growth that is in line with sustainable environmental and economic development, a large number of food industry wastes are being recovered as added-value products by more sustainable and innovative extraction processes to be incorporated into cosmetic products amongst others. Although the potential of bioactive compounds extracted from food is already known, the specific biological activity is now being studied and reported. Conclusions Natural active food-derived ingredients are marketed as having several benefits on the skin. Their incorporation in food supplements and cosmetics is a reality already marketed. The truth about the benefits of food ingredients in cosmetics is not always properly discussed. The trend of “beauty from within” by oral supplementation is now accompanying the other trend that is “from the kitchen table to the skin”, that refers to the possibility to create cosmetics with the ordinary ingredients one have in the kitchen.

A Randomized Double-Blind Controlled Trial Comparing Extra Virgin Coconut Oil with Mineral Oil as a Moisturizer for Mild to Moderate Xerosis

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Xerosis is a common skin condition (1) characterized by dry, rough, scaly, and itchy skin, (2) associated with a defect in skin barrier function, and (3) treated with moisturizers. People in the tropics have effectively used coconut oil as a traditional moisturizer for centuries. Recently, the oil also has been shown to have skin antiseptic effects. A moisturizer with antiseptic effects has value, but there are no clinical studies to document the efficacy and safety of coconut oil as a skin moisturizer. This study aimed to determine the effectivity and safety of virgin coconut oil compared with mineral oil as a therapeutic moisturizer for mild to moderate xerosis. A randomized double-blind controlled clinical trial was conducted on mild to moderate xerosis in 34 patients with negative patch-test reactions to the test products. These patients were randomized to apply either coconut oil or mineral oil on the legs twice a day for 2 weeks. Quantitative outcome parameters for effectivity were measured at baseline and on each visit with a Corneometer CM825 to measure skin hydration and a Sebumeter SM 810 to measure skin lipids. For safety, transepidermal water loss (TEWL) was measured with a Tewameter TM210, and skin surface hydrogen ion concentration (pH) was measured with a Skin pH Meter PH900. Patients and the investigator separately evaluated, at baseline and at each weekly visit, skin symptoms of dryness, scaling, roughness, and pruritus by using a visual analogue scale and grading of xerosis. Coconut oil and mineral oil have comparable effects. Both oils showed effectivity through significant improvement in skin hydration and increase in skin surface lipid levels. Safety was demonstrated through no significant difference in TEWL and skin pH. Subjective grading of xerosis by the investigators and visual analogue scales used by the patients showed a general trend toward better (though not statistically evident) improvement with coconut oil than with mineral oil. Safety for both was further demonstrated by negative patch-test results prior to the study and by the absence of adverse reactions during the study. Coconut oil is as effective and safe as mineral oil when used as a moisturizer.

Natural Oils for Skin-Barrier Repair: Ancient Compounds Now Backed by Modern Science

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Natural plant oils are commonly used as topical therapy worldwide. They are usually easily accessible and are relatively inexpensive options for skin care. Many natural oils possess specific compounds with antimicrobial, antioxidant, anti-inflammatory, and anti-itch properties, making them attractive alternative and complementary treatments for xerotic and inflammatory dermatoses associated with skin-barrier disruption. Unique characteristics of various oils are important when considering their use for topical skin care. Differing ratios of essential fatty acids are major determinants of the barrier repair benefits of natural oils. Oils with a higher linoleic acid to oleic acid ratio have better barrier repair potential, whereas oils with higher amounts of irritating oleic acid may be detrimental to skin-barrier function. Various extraction methods for oils exist, including cold pressing to make unrefined oils, heat and chemical distillation to make essential oils, and the addition of various chemicals to simulate a specific scent to make fragranced oils. The method of oil processing and refinement is an important component of selecting oil for skin care, and cold pressing is the preferred method of oil extraction as the heat- and chemical-free process preserves beneficial lipids and limits irritating byproducts. This review summarizes evidence on utility of natural plant-based oils in dermatology, particularly in repairing the natural skin-barrier function, with the focus on natural oils, including Olea europaea (olive oil), Helianthus annus (sunflower seed oil), Cocos nucifera (coconut oil), Simmondsia chinesis (jojoba oil), Avena sativa (oat oil), and Argania spinosa (argan oil).

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EEMCO guidance for the assessment of dry skin (xerosis) and ichthyosis: Clinical scoring systems

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The wound healing properties of jojoba (Simmondsia chinensis) liquid wax (JLW) were studied in vitro on HaCaT keratinocytes and human dermal fibroblasts, which are involved in wounded skin repair. JLW cytotoxicity was evaluated by the crystal violet staining and the neutral red uptake endpoint. Induction of wound healing by JLW was assessed by scratch wound assay on cell monolayers. The involvement of signaling pathways was evaluated by the use of the Ca(2+) chelator BAPTA and of kinase inhibitors, and by Western blot analysis of cell lysates using anti-phospho antibodies. Collagen and gelatinase secretion by cells were assayed by in-cell ELISA and zymography analysis, respectively. Cytotoxicity assays showed that the toxic effects of JLW to these cells are extremely low. Scratch wound experiments showed that JLW notably accelerates the wound closure of both keratinocytes and fibroblasts. The use of inhibitors and Western blot revealed that the mechanism of action of JLW is strictly Ca(2+) dependent and requires the involvement of the PI3K-Akt-mTOR pathway and of the p38 and ERK1/2 MAPKs. In addition, JLW was found to stimulate collagen I synthesis in fibroblasts, while no effect was detected on the secretion of MMP-2 and MMP-9 gelatinases by HaCaT or fibroblasts. Taken together, data provide a pharmacological characterization of JLW properties on skin cells and suggest that it could be used in the treatment of wounds in clinical settings.

Evaluation of additive effects of hydrolyzed jojoba (Simmondsia chinensis) esters and glycerol: A preliminary study

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Background: Glycerol has long served the topical prescriptive and personal care industry as a versatile and functional active and inactive ingredient. In skin care products, it acts primarily as an emollient, softening the skin through robust humectant hydration action. Hydrolyzed Jojoba Esters K-20W (K-20W) have been shown to increase skin hydration and improve sensory skin "feel" when included in a variety of skin, hair, and nail care cosmetic/personal care formulations. The addition of glycerol and hydrolyzed jojoba esters provides a substantial long-acting 24 h (moisturizing) skin hydration effect for topical products. Aim: A small pilot study was conducted to support the "proof of concept" that an enhanced, additive role exists between these two ingredients resulting in a long-term (24 h) skin moisturization effect. Method: Topical treatments were applied to the skin (lower leg) of subjects, and evaluations were made at baseline and 8- to 24-h post-application. Skin hydration data were obtained via bio-instrumental transepidermal water loss (TEWL) measurements and expert clinical skin grading, including standardized digital clinical photography. Results: Clinical skin grading evaluations and TEWL measurements found that significantly lower evaporative (P < 0.05) TEWL values occurred in the topical formulations containing 3.75% glycerol and 1.25% K-20W (hydrolyzed jojoba esters) than with glycerol alone in a standard base skin care lotion at 8 and 24 h posttreatment. Conclusion: This preliminary data "proof of concept" supports the position that glycerol and hydrolyzed jojoba esters work in tandem to enhance skin moisturization for at least 24 h. This unique moisturizing potential may prove valuable in the future development of cosmetic and over-the-counter/prescriptive topical products, including new medicaments containing botanicals. This fact is further reinforced with the recent greater commercial use and demand for defined safe botanicals in cosmetic as well as pharmaceutical topical formulations. Additional mechanistic studies are underway.