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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 2  |  Issue : 2  |  Page : 58-63

A randomized, assessor-blinded, comparative study to evaluate the efficacy and safety of oat extract-based moisturizer in adult individuals with dry skin


1 Consultant Dermatologist, Sujala Polyclinic and Laboratory, Basaveshwaranagar, Bengaluru, Karnataka, India
2 Consultant Dermatologist, Sparkle Skin Aesthetic Centre, Vashi, Navi Mumbai, Maharashtra, India
3 Medical Advisor, Medical Affairs, Wockhardt Limited, Wockhardt Towers, Mumbai, Maharashtra, India
4 Head, Medical Affairs, Wockhardt Limited, Wockhardt Towers, Mumbai, Maharashtra, India
5 Medical Monitor, Clinical Operations, Wockhardt Limited, Wockhardt Towers, Mumbai, Maharashtra, India
6 Project Manager, Clinical Operations, Wockhardt Limited, Wockhardt Towers, Mumbai, Maharashtra, India
7 Head, Clinical Operations, Wockhardt Limited, Wockhardt Towers, Mumbai, Maharashtra, India

Date of Web Publication10-Jul-2018

Correspondence Address:
Dhammraj Madhukar Borade
Medical Advisor, Medical Affairs, Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Mumbai - 400 051, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/CDR.CDR_37_17

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  Abstract 

Background: Dry skin or xeroderma is a very frequent condition which occurs at any age. Moisturizers including conventional oatmeal have been widely used to improve dry skin conditions. Oat-based moisturizer can protect, hydrate, and promote the endogenous barrier repair. Aim: This study aims to evaluate the efficacy and safety of oat extract-based moisturizer in adult individuals with dry skin. Materials and Methods: This study was a treatment-randomized, assessor-blinded, no treatment controlled, comparative study. A total of 36 individuals were included in the study. Oat extract-based moisturizer (test product) and control treatment (no product application) were randomized, as per randomization plan and applied to all individuals on the surface of volar forearm 2 cm (1 cm radius) in diameter. In addition, right cheek as control site and left cheek as test site (oat extract-based moisturizer lotion) were considered for sebum level and facial skin pH analysis. Results: Oat extract-based moisturizer possessed excellent skin moisturizing properties. Both the Corneometer® and modified Kligman score, respectively, showed significant improvement (P < 0.0001) in skin hydration and decrease in skin dryness with respect to baseline till 24 h postapplication. Furthermore, Cutometer® reading had statistically significant increase in skin elasticity as compared to baseline till 6 h postapplication. There was no statistically significant effect on skin pH and sebum level as compared to control treatment. This concludes that oat extract-based moisturizer is effective in improving skin hydration and elasticity without any change in skin pH and sebum levels. Conclusion: Test product (oat extract-based moisturizer lotion) was safe and well tolerated. Efficacy analysis showed that the effect of oat extract-based moisturizer was significant in terms of skin hydration and skin elasticity.

Keywords: Dry skin, oat extract-based moisturizer, pH of facial skin, skin elasticity, skin hydration


How to cite this article:
Sacchidanand SA, Udare S, Borade DM, Narayanan V, Katare S, Mane A, Shah A. A randomized, assessor-blinded, comparative study to evaluate the efficacy and safety of oat extract-based moisturizer in adult individuals with dry skin. Clin Dermatol Rev 2018;2:58-63

How to cite this URL:
Sacchidanand SA, Udare S, Borade DM, Narayanan V, Katare S, Mane A, Shah A. A randomized, assessor-blinded, comparative study to evaluate the efficacy and safety of oat extract-based moisturizer in adult individuals with dry skin. Clin Dermatol Rev [serial online] 2018 [cited 2018 Sep 21];2:58-63. Available from: http://www.cdriadvlkn.org/text.asp?2018/2/2/58/236337


  Introduction Top


The skin is the largest body organ and works as the main protective barrier against damage to internal tissues from trauma, ultraviolet (UV) light, temperature, toxins, and bacteria.[1],[2] The skin is also accountable for sensory perception, temperature regulation, production of Vitamin D, and excretion of waste products. In addition to preventing harmful substances from entering the body, it also controls the loss of vital substances from the body. It is therefore important that the skin barrier remains intact to allow the body to perform this essential function.[2]

Dry skin or xeroderma is a very frequent condition which occurs at any age.[3] Dry skin is triggered by hereditary factors, age-related decrease in intercellular lipid, and natural moisturizing factors such as free amino acids and specific salts in the stratum corneum. In addition, the disturbance of the skin barrier by extrinsic stimuli such as a sudden change in weather and contact with chemical agents also induces dry skin.[4]

The consequences of the dry skin include impairment in barrier function, inflammation of the skin, and loss of suppleness, that leads to the cracking of the skin. It is multifactorial and may be acquired, constitutional, and genetic in origin.[5]

Moisturizers have been conventionally used to improve dry skin.[6] Moisturizers can reduce transepidermal water loss (TEWL) by promoting epidermal barrier repair. Moisturizers soothens the exposed dermal nerve endings by creating a temporary artificial barrier, and restore skin softness. Lately, moisturizers have been shown to prevent the induction of primary irritation and to accelerate the processes by which the skin heals itself.[7]

Oat extract-based moisturizer contains beta-glucans which forms an occlusive and protective barrier on the skin and thereby helps to retain moisture and reduce irritation and itching. It also contains natural antioxidants such as flavonoids, vital minerals, vitamins, and antioxidant enzymes to nourish skin and protect from UV damage. In addition, oat extract moisturizer contains a special class of anti-inflammatory substances called “Avenanthramides” which reduce skin redness, irritation, itching, and swelling, while “Avenecins” present in oat extracts are cleansing and antifungal in nature.[8]

Various studies have been conducted to evaluate efficacy and safety of conventional oatmeal. However, risks of skin sensitization and allergy with oat extract moisturizer use are linked with its amino acid and protein constituents. Therefore, oat extract-based moisturizers derived through nonchemical process and free of protein and amino acid present the advantages of being nonsensitizing/nonallergenic and are enriched with beta-glucans, flavonoids, and vitamins. This provides manifold benefits such as enhanced aqueous solubility, deeper penetration reaching the dermis, and soothing, anti-irritation, anti-aging, and rejuvenating benefits to the skin. Therefore, to evaluate these considerations, moisturizing properties of protein and amino acid-free oat extract-based moisturizer need to be studied as well as compared with population receiving no treatment. Hence, this study evaluates and compares the moisturizing properties of oat extract-based moisturizer lotion for 24 h with respect to control in adult individuals with dry skin.


  Materials and Methods Top


Study design and participants

This was a treatment-randomized, assessor-blinded, comparative study to evaluate the efficacy and safety of oat extract-based moisturizer in dry skin adult individuals. The study was conducted with Ethics Committee Approval and in compliance with ICH-GCP and Declaration of Helsinki.

After informed consent, male individuals of good health with age between 18 and 45 years with Corneometer ® reading of 0–30 (arbitrary unit) and modified Kligman score between 1 and 2 were screened as per the inclusion and exclusion criteria.

Corneometer ® instrument was used to determine skin dryness with the following scale: <30 – very dry skin, 30–40 – dry skin, and >40 normal skin.

Study procedure

At screening visit, all potential individuals were screened as per the inclusion and exclusion criteria. Each individual was kept under controlled environment for adaptation to temperature and humidity for at least 18 h before application.

The baseline scores for all the study assessment parameters were recorded before application of test product.

The right and left volar surfaces of forearm (near wrist) were considered as the application sites. All the 36 individuals received both the test product (oat-based moisturizing lotion - Nourish oat from Wockhardt) and control treatment (no product application). The test product application and control treatment were randomized to either of the volar surface of the forearm as per randomization plan. The test product was applied only once on 2 cm diameter of volar surface and individual was not allowed to wash/clean the forearms until the end of the study.

In addition, for exploratory analysis of effect on sebum level and facial pH of test product, it was applied only once on cheeks of all individuals. The right cheek was considered as control site (no product application) and left cheek as test site (oat-based moisturizing lotion - Nourish oat from Wockhardt). The individuals were not allowed to wash/clean the cheeks until the end of the study.

Study assessments

The test and control sites on volar surface were assessed for skin hydration (using Corneometer ®), skin elasticity (using Cutometer ®), and clinical evaluation of skin dryness (using modified Kligman scale). The skin hydration and skin elasticity were measured at both sites at baseline and at 2, 6, 12, and 24 h after application of test product. The modified Kligman score for skin dryness was assessed at baseline and at 24 h after application.

The test and control site cheeks were assessed for sebum level (using Sebumeter ®) and facial skin pH (using pH meter) at baseline and at 6 h and 24 h after application.

Instrument details

The skin hydration, sebum level, and facial skin pH were assessed using multiprobe adapter (MPA 6) system from Courage + Khazaka electronic GmbH. Corneometer ® CM 825 probe was used to measure skin surface hydration based on capacitance measurement of a dielectric medium and detect even slight changes in the hydration level. The skin hydration is reported in arbitrary units. As per the specifications, the scale used for skin hydration was <30 – very dry skin, 30–40 – dry skin, and >40 – normal skin. Sebum level of skin was measured using Sebumeter ® SM 815 probe which works on the principle of grease spot photometry. The mat tape of the Sebumeter ® is brought into contact with skin, and it becomes transparent in relation to the sebum on the surface of the measurement area. Then, the tape is inserted into the aperture of the device, and the transparency is measured by a photocell. The light transmission represents the sebum content. Skin-pH-Meter PH 905 probe is used to measure the facial skin pH. The measurement is based on a high-quality combined electrode, where both glass H+ ion-sensitive electrode and additional reference electrode are placed in one housing. It is connected to a probe connector containing the measurement electronics.

The Cutometer ® dual MPA 580 was used to measure elasticity of the upper layer of skin using negative pressure which deforms the skin mechanically. The measuring principle is based on the suction method. Negative pressure is created in the device, and the skin is drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth is determined by a noncontact optical measuring system. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the measurement.[9]

Modified Kligman score is validated scale used in clinical practice and research activities for grading the skin dryness, namely 0 - healthy skin with no evidence of dryness even on scratching, 1 - mild dryness on scratching, 2 - moderate dryness, small dry flakes, or visible whitening of dermatoglyphic triangles without scratching, 3 - severe, well-defined xerosis with dermatoglyphic triangles uplifted and redness are readily apparent.

Statistical considerations

The statistical analysis was done using SAS ® statistical software (Version: 9.4; SAS Inc., USA). For continuous variables, the within-treatment analysis was conducted to compare baseline to posttreatment data using paired t-test. Analysis of variance (ANOVA) with multiple comparison test is used to assess the effect of the product application from baseline to different time points during treatment. For categorical variables, the frequency and percentage of each category were provided using Chi-square test. All statistical tests of hypothesis employed a level of significance of 0.05.


  Results Top


After screening of healthy male volunteers, 36 individuals were enrolled in the study. All the 36 individuals completed the study. The baseline characteristics of the individuals are provided in [Table 1].
Table 1: Demographics and baseline characteristics

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A total of n = 36 individuals were dosed in the study. Mean age (± SD) of the participants was 35 years (± 5.3) had median of 36. Out of 36 individuals, all were male (100%) and Asian (100%).

Primary endpoints

Corneometer ® measurements

(Test group refers together to the test sites of the 36 study participants while control group refers together to the “no treatment” sites of the same 36 participants).

In test group, significant increase in hydration (<0.0001) was observed at all-time points (2 h, 6 h, 12 h, and 24 h) compared to baseline. No increase in hydration from baseline was observed in control group. Intergroup increase in skin hydration was significantly higher (<0.0001) in test group compared with control [Table 2].
Table 2: Mean (change from baseline) summary of Corneometer® measurement

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Secondary endpoints

Cutometer ® measurements

Test group showed statistically significant increase in skin elasticity compared to baseline for 2 h. No improvement in elasticity compared to baseline for all-time points were observed with control group. Intergroup comparison showed no difference in test and control groups [Table 3].
Table 3: Summary of mean change from baseline of Cutometer® measurement

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Modified Kligman score

Both treatments (test and control) observed significant reduction of the skin dryness (modified Kligman score, <0.0001)) compared to baseline for all-time points. Intergroup comparison, observed reduction of skin dryness was significantly higher in test (<0.0001) compared with control treatment at 24 hour. [Table 4].
Table 4: Summary of mean change from baseline of modified Kligman score

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Exploratory endpoints

Sebumeter ® measurements

There was no statistically significant change observed in sebum level after application of the test or control products with respect to baseline and time points [6 h and 24 h; [Table 5].
Table 5: Summary of Sebumeter® measurements (actual mean)

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pH meter measurements

There was no statistically significant change observed in skin pH after application of the test or control products with respect to baseline and time points [6 h and 24 h; [Table 6].
Table 6: Summary of pH meter measurements (actual mean)

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Product safety

Overall, no adverse events were observed during the study.


  Discussion Top


The results of this treatment-randomized, assessor-blinded, comparative study to evaluate the efficacy and safety of oat extract-based moisturizer in adult individuals with dry skin showed that oat extract-based moisturizer had significant skin moisturizing properties. The Corneometer ® readings show that there was significant increase (P < 0.0001) in skin hydration level with respect to baseline at each time point till 24 h postapplication. Moreover, modified Kligman score suggests that there was statistically significant decrease in skin dryness as compared to baseline till 24 h postapplication.

Corneometer ® readings and modified Kligman scores suggest that oat extract-based moisturizer is helpful in reducing skin dryness and improving smoothness, softness, and the natural health of the skin.

Cutometer ® readings suggest that oat extract-based moisturizer had statistically significant increase in skin elasticity as compared to baseline till 6 h postapplication. There was no statistically significant effect on skin pH and sebum level as compared to control treatment. Hence, “acid mantle” of the skin was maintained. The skin pH ranged from 5 to 6 for all the individuals during the conduct of study. The acidity of the skin surface is crucial for physiological skin functions and cutaneous antimicrobial defense. Furthermore, there was no increase in skin oiliness (sebum) which could be an important attribute for moisturizers used along with acne therapy.

Narayanan et al. in their study observed that the oat moisturizer (nourish oat) possesses good anti-itching and moisturizing properties in all age groups. Its safety and tolerability was seen in a study conducted in 528 patients aged 2–65 years for 8 weeks having atopic dermatitis/xerosis, eczema, acne, and psoriasis and other types of dry skin conditions.[10]

In another study, the allergic reactions of topical oat and rice colloidal grain were evaluated in a double-blind, randomized patch study. Two different concentrations of oat and rice colloidal grains (0.007% and 0.7%) were applied occlusively on the back of 65 children aged 6 months to 2 years (43 were atopic and 22 were normal). The study concluded that topical colloidal grains can be used as an adjunct in the management of mild atopic dermatitis in children under 2 years of age. There was no evidence of sensitization to topical colloidal grains in the groups studied.[11]

Personal care products containing oatmeal were observed to be safe and effective with very low irritant and allergenic sensitization potential. No allergies were reported by consumers of 445,820 products sold during a 3-year period. In addition, it also showed sustained skin moisturizing properties in individuals with dry skin which lasted up to 2 weeks after product discontinuation.[12]

A study by Reynertson et al. demonstrated the benefits of colloidal oatmeal skin protectant lotion in 29 healthy female controls with bilateral mild-to-moderate itching due to dry skin on their lower legs. After treatment, it was observed that the colloidal oatmeal extract reduced pro-inflammatory cytokines in vitro and remission in all the clinical signs such as skin dryness, scaling, roughness, and itch intensity.[13]

Clinical studies for Avenacare™ in skin care have shown reduction in skin irritation, UV protection with reduction in symptoms of sunlight exposure, and anti-aging benefits with use of oat extract moisturizer.

The use and efficacy of colloidal oatmeal for skin irritation reduction and moisturizing are well documented.[14]

Scientific reports indicate beta-glucan is a film-forming moisturizer, a biological response modifier, and a promoter of wound healing. Skincare actions of oat beta-glucan such as anti-radiation, anti-wrinkle, and anti-aging were most likely attributed to its long-lasting and film-forming property. Furthermore, beta-glucan deeply penetrates the epidermis and reaches the dermis by passing through the gaps between cells. Experimental study showed that 28% of the applied oat beta-glucan entered the skin and around 4% reached the dermis. In dermis, it activates immune cells, mainly macrophage, through an interaction between glucan and glucan receptors on the surface of macrophage. This triggers several indirect, cytokine-mediated reactions with fibroblasts that stimulate collagen synthesis. In 8 weeks treatment of facial line and wrinkle, beta-glucan use significantly reduces the height and depth of wrinkle and overall roughness. Thus, evidence supports use of oat beta-glucan in the care and maintenance of healthy skin and the cosmetic treatment of the signs of aging.[15]

Furthermore, improved collagen synthesis may indirectly help in upsurge in depths of skin hydration and helps to maintain normal intrinsic turgor of skin through improvement of dermal water content which accumulates 60%–70% of total skin water within collagen and glycosaminoglycan network.[16]

The present study confirms that oat extract-based moisturizer has significant effect on skin hydration and elasticity and is well tolerated. As it does not contain protein and amino acid, its nonsensitizing and nonallergic properties add to its value in the treatment of atopic dermatitis and in protein-sensitive population.


  Conclusion Top


The results demonstrated that the effect of oat extract-based moisturizer was significant in improving skin hydration and skin elasticity as compared to controls. Oat extract-based moisturizer was seen to be safe and well tolerated.

Acknowledgment

All named authors meet the ICMJE criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. We acknowledge the contribution of Karmic Life sciences, Ahmadabad for study execution and help provided for writing of manuscript. Wockhardt Pvt., Ltd., funded the study execution and manuscript writing assistance for this article.

Financial support and sponsorship

Wockhardt Pvt., Ltd., funded the study execution and manuscript writing assistance for this article.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

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Faria WC, Damasceno GA, Ferrari M. Moisturizing effect of a cosmetic formulation containing pequi oil (Caryocar brasiliense) from the Brazilian cerrado biome. Braz J Pharm Sci 2014;50:131-6.  Back to cited text no. 1
    
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Your Dermatology Pocket Guide: Common Skin Conditions Explained. Available from: http://www.nes.scot.nhs.uk/media/705715/dermatology_guide__amended_may_2012_.pdf. [Last accessed on 2016 Jun 14].  Back to cited text no. 2
    
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Bazin R, Fanchon C. Equivalence of face and volar forearm for the testing of moisturizing and firming effect of cosmetics in hydration and biomechanical studies. Int J Cosmet Sci 2006;28:453-60.  Back to cited text no. 3
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Kapoor S, Saraf S. Assessment of viscoelasticity and hydration effect of herbal moisturizers using bioengineering techniques. Pharmacogn Mag 2010;6:298-304.  Back to cited text no. 8
    
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About Instrument Details. Available from: http://www.courage-khazaka.de/index.php/en/products/59-scientific/128-mpa#mpa4. [Last accessed on 2017 Jul 10].  Back to cited text no. 9
    
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Narayanan V, Ganjod A, Kandhe G. Efficacy and tolerability of an oatmeal moisturizer containing colloidal oatmeal for dry skin conditions: A post marketing study. Indian J Clin Pract 2016;27:1117-22.  Back to cited text no. 10
    
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Pigatto P, Bigardi A, Caputo R, Angelini G, Foti C, Grandolfo M, et al. An evaluation of the allergic contact dermatitis potential of colloidal grain suspensions. Am J Contact Dermat 1997;8:207-9.  Back to cited text no. 11
    
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Reynertson KA, Garay M, Nebus J, Chon S, Kaur S, Mahmood K, et al. Anti-inflammatory activities of colloidal oatmeal (Avena sativa) contribute to the effectiveness of oats in treatment of itch associated with dry, irritated skin. J Drugs Dermatol 2015;14:43-8.  Back to cited text no. 13
    
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Ilnytska O, Kaur S, Chon S, Reynertson KA, Nebus J, Garay M, et al. Colloidal oatmeal (Avena sativa) improves skin barrier through multi-therapy activity. J Drugs Dermatol 2016;15:684-90.  Back to cited text no. 14
    
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Pillai R, Redmond M, Roding J. Anti-wrinkle therapy: Significant new findings in the non-invasive cosmetic treatment of skin wrinkles with beta-glucan. Int J Cosmet Sci 2005;27:292.  Back to cited text no. 15
    
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Guzmàn-Alonso M, Cortazar TM. Water content at different skin depths and the influence of moisturizing formulations. Househ Pers Care Today 2016;11:36-9.  Back to cited text no. 16
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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