• Aloe Vera
• Avenanthramides
• Black & White Tea
• Blackberry
• Chamomile
• COFFEEBERRY^™
• Dill
• Feverfew
• Grape Seed Extract
• Green Tea
• Lavender
• Licorice
• Oats
• Olive Leaf
• Pomegranate
• Shea Butter
• Shiitake
• Silymarin
• Soy
• Wheat
• Willowherb
• Ylang-Ylang

Oats

History and Origin: Colloidal Oatmeal

The use of oats on skin care dates to ancient Egypt.¹ Whole or rolled oats were used in soothing baths. Oats used in this way did not disperse well in baths and were messy. In 1945, technological advances permitted the manufacture, of colloidal oatmeal which is prepared from de-hulled oats ground to a fine powder.The first ready to use colloidal oatmeal bath treatment was developed and used at the Mayo Clinic in 1945. Colloidal oatmeal retains the moisturizing effects of the whole oat grain, but disperses more easily in bath water and can also be added to creams and lotions for use in topical products. Colloidal oatmeal added to bath water forms a viscous hydrocolloid gel on the skin surface.

Activity, Properties, Chemical Structure

• Colloidal oatmeal contains 10% to 18% protein, 60% to 64% polysaccharides as well as lipids, enzymes, saponins, vitamins, flavonoids and prostaglandin synthesis inhibitors.²
• Oatmeal can help restore normal ph in skin conditions where pH has increased. In this setting, it acts as a buffering agent, thereby aiding in the maintenance of a healthy skin barrier.
• The moisturizing properties of colloidal oatmeal are provided by a hydrophilic film that forms at the skin surface. It consists of humectant and water-binding constituents and lipids.
• Starches are important constituents of colloidal oatmeal. They are highly hydrophilic and can absorb large quantities of water.^3,4 Proteins contained in colloidal oatmeal further contribute to its water affinity.^4,5 The unique lipid composition of colloidal oatmeal⁶ participates in the formation of a film at the skin’s surface.^7,8 Oat triglycerides and phospholipids, as well as oleic, linoleic and linolenic acids, which are contained in oat lipids are important stratum corneum components.⁷
• Colloidal oatmeal provides gentle cleansing without loss of the skin’s moisture content. It thus helps prevent skin dryness and the clinical signs associated with skin dryness.⁸

• Components	Activities	Applications
  Saponins	Can absorb and solubilize dirt on skin	Gentle cleansing
  Oat polysaccharides /oat	Bind to skin	Soothing, form protective barrier
  beta-glucans	Immunomodulatory	Moisturizing
  Carbohydrates	Hydrophilic	Moisturizing
  Proteins	Hydrophilic, emulsifying	Moisturizing, water-binding, barrier enhancing
  Lipids	Emulsifying Antioxidant
  Flavonoids	Anti-oxidant

Preclinical Data

• The activity of 2 different oat extracts was compared in 12 individuals whose volar forearms were pretreated with the 2 extracts and occluded for 2 hours. Then a patch with a 1% sodium lauryl sulfate solution was applied to test sites for 24 hours. Skin Redness was measured by Chromametry and laser-Doppler. Both extracts caused a marked reduction in blood flow increase as well as inhibition of redness. This demonstrates the ability of oatmeal extracts to prevent skin aggravation.¹²

Clinical Studies

Clinical Evaluation of the Efficacy of a Colloidal Oatmeal Based Lotion on
Ashy Skin¹⁴

• 19 female subjects (23-50 years) with a Fitzpatrick Skin Type IV-VI and at least moderate bilateral “ashen” skin on both lower legs were enrolled in an investigator-blinded, randomized study of an oatmeal containing lotion.
• Subjects applied an oatmeal containing lotion to one of their lower legs twice daily for 2 weeks.
• Skin improvements were measured by clinical evaluations, subject self-assessments, high-resolution digital imaging and D-Squame tape stripping.
• Clinical evaluations of the subjects’ lower legs revealed significant improvements
  (p< 0.05) in the appearance of skin ash, flaking and dryness as early as Day 1.
• Subjects perceived significant reductions in skin tightness and itching. These improvements were maintained throughout the study period. Subjects also noticed significant (p<0.05) improvements in the appearance of skin ash and scale as early as Day 1 when compared to baseline values. They also perceived improvements in skin texture, smoothness, softness and the overall look and feel of their skin at the Day 1 time point. These improvements were maintained throughout the course of the
  2-week study.
• D-Squame tape stripping was performed to quantitate the corneocytes of the dry, ashen skin. The size and number of corneocytes removed from the stratum corneum by the adhesive disks were analyzed and the Desquamation Index (DI) score was calculated to determine the severity of the dry skin. At baseline, large numbers of corneocytes were removed. The disks were white; the DI score was high, indicating moderately dry skin. After 1 day of of an oatmeal containing lotion use, the DI score was significantly (p<0.05) lower, indicating improved skin moisturization. The DI score showed further skin improvements after 7 and 14 days of of an oatmeal containing lotion use.
• High-resolution digital images taken at baseline, Day 1 and Day 14 show visible improvements in skin ash and scale as well as in skin textural lines as early as Day 1. Skin ash continued to improve visibly through study end.

Alleviating Itchy, Extra Dry Skin with an Oatmeal Skin Protecant Lotion¹⁶

A controlled clinical study was conducted to evaluate the effectiveness of a body lotion containing colloidal oatmeal, oat extract, oat oil and a skin protectant in alleviating extra dry, itchy skin. Healthy female subjects with chronic itch and extra dry skin on their lower legs were enrolled in the 2-week study. Subjects applied the lotion to the lower leg area twice a day. Benefits of the lotion were assessed by clinical evaluations, instrumental measures and self-assessments. Itch intensity was monitored daily through patient diaries.

Clinical evaluations demonstrated significant improvements (p<0.05) in dryness, scaling and skin roughness as early as 1 day after use of the triple oat skin protectant lotion. In addition, adhesive skin samples showed a significant decrease (p<0.05) in fine and course flaking. Transepidermal water loss values decreased over time. Most important, patients perceived significant mean improvements in itch intensity levels after only 1 day of use of the oatmeal, skin protectant lotion.

Clinical Evaluation of the Efficacy of a Colloidal Oatmeal, Oat Essence and Ceramides Based Formula in Compromised Skin¹⁷

A four-week, monadic clinical study was conducted to assess the tolerance of a colloidal oat-based regimen (cream and cleanser) on babies and children with itchy, extra dry, eczematous skin. The regimen required the application of the cream twice a day to the entire body and the use of the cleanser in all routine bathing after a 2-day washout period from their prior emollients and cleansers. Patients were allowed to continue their topical eczema medications and oral antihistamines. Clinical evaluations, including the Investigators Global Assessment (IGA) and the Eczema Area and Severity Index (EASI) scoring, were performed at baseline and Weeks 2 and 4. The investigator was also responsible for evaluating the categories of skin dryness, scaling, and tactile roughness utilizing a 0-4 scale. In addition, the Visual Analog Scoring system for pruritus and the Infant’s/Children’s DermatologyQuality of Life (QOL) Index were assessed.

A total of twenty-five male or female patients, ages 2 months to 6 years, were enrolled, with twenty three completing the study. The clinical evaluations showed significant improvements (p<0.05) in IGA, EASI scores, dryness and tactile roughness scores after 2 and 4 weeks of colloidal oatmeal product use.

In addition, the improvements in the skin condition correlated with improvements in the QOL (Standardized Quality of Life Indices) indices after 4 weeks. Overall, the colloidal oatmeal products were well tolerated by the infants and children and there were no significant increases in dry skin associated with eczema severity, pruritus or other cutaneous irritation parameters.

The Effectiveness of an Oatmeal Lotion in Improving and Maintaining Barrier Function and Moisture Levels of Moderate to Severely Dry Skin¹⁸

A five-week clinical study was performed to demonstrate the effectiveness of an oatmeal skin protectant lotion in improving the moisture and barrier function of moderate to severely dry skin. A standard Kligman Regression model was utilized. Twenty five healthy female subjects with moderate to severe dry skin on the lower legs completed the study. Following the conditioning period, subjects used the oatmeal lotion twice a day for three weeks. For the remaining two weeks of the study, no test product was applied to the lower leg area. Moisturization and transepidermal water loss measurements were obtained 11 times during the study.

Moisturization measurements showed a significant increase (p<0.05) in skin hydration at all time points during the application phase of the study (Days 3, 7,14, 21). During the 2-week regression phase (no application) a significant improvement (p<0.05) in skin hydration was still noted at all six time points measured (Days 22, 24,28, 30, 32 and 34). Transepidermal water loss measurements showed a significant improvement (p<0.05) in skin barrier at all time points during the application phase and during days 22, 24, 28 and 30 of the regression phase, which was 9 days after the last application of the oatmeal, skin protectant lotion. This oatmeal, skin protectant lotion was effective in improving the moisturization and skin barrier of moderate to severely dry skin.

Significant improvements (p<0.05) in skin moisture were measured for two weeks post application phase. The skin barrier of these subjects still showed a significant improvement (p<0.05) at all time points up to and including 9 days after the last application of the oatmeal, skin protectant lotion.

Safety and Tolerability

• Colloidal oatmeal is extremely tolerable even by patients with dry, sensitive or irritated skin.
• Early studies demonstrated its ability to soothe the dry or irritated skin of both geriatric and pediatric populations.

References

1. Miller A. Oat derivatives in bath products. Cosmet Toiletries 1979;94:72-80.
2. Johnson & Johnson, Skillman, NJ; data on file.
3. Paton D. (1986) Oat starch: physical, chemical and structural properties. in Webster FH, ed., Oats: chemistry and technology. Saint Paul, MN, American Association of Cereal Chemists, Inc.93-120.
4. Rawlings AV et al. (2002) Humectants. in Skin Moisturization. Leyden and Rawlings Eds. New York, NY. Marcel Dekker, Inc.; 245-266.
5. Peterson DM, Brinegar AC. Oat storage proteins. In: Webster FH, ed. Oats: Chemistry and Technology. St. Paul, Minn: American Association of Cereal Chemists, Inc. 1986;153-203.
6. Youngs VL. Oat lipids and lipid-related enzymes. In: Webster FH, ed. Oats: Chemistry and Technology. St. Paul, MN; American Association of Cereal Chemists, Inc. 1986; 205-226.
7. Zhou M, Robards K, Glennie-Holmes M et al. Oat lipids. J. Am Oil Chem Soc. 1999;76:159-169.
8. Grais ML. Role of colloidal oatmeal in dermatologic treatment of the aged. AMA Arch Derm Syphilol 1953; 68:402-407.
9. Estrada A, Yun CH, Van Kessel A et al. Immunomodulatory activities of oat β glucan in vitro and in vivo. Microbiol Immunol. 1997;41:991-998.
10. Federal Register. Skin Protectant Drug Products for Over-the-Counter Human Use; final monograph. Rockville, MD: Food and Drug Administration, US Dept. of Health and Human Services; vol. 68, No. 107, 3362; June 4, 2003.
11. Downie J. Ancient skin remedies come of age for today’s health-conscious consumers. The Role of Natural Ingredients in Dermatology. Skin & Allergy News. 2004 ;35.
12. Vie K, Cours-Darne S, Vienne MP et al. Modulating effects of oatmeal extracts in the sodium lauryl sulfate skin irritancy model. Skin Pharmacol Appl Skin Physiol. 2002;15: 120-124.
13. Boisnic S, Branchet-Gumila MC, Coutanceau C. Inhibitory effect of oatmeal extract oligomer on vasoactive intestinal peptide-induced inflammation in surviving human skin. Int. J. Tissue React. 2003;23: 41-46.
14. Nebus J, Smith G, Miller D, Wallo W, Kurtz ES. Alleviating dry, ashen skin in patients with skin of color. (Poster)
15. Alleviating Itchy, Extra Dry Skin with an Oatmeal Skin Protectant Lotion. Poster presented at the 64^th Annual Meeting of the American Academy of Dermatology, March 2006.
16. Clinical evaluation of the efficacy of a colloidal oatmeal, oat essence and ceramides based formula in compromised skin. Poster presented at the 66^th Annual Meeting of the American Academy of Dermatology, February, 2008.
17. The Effectiveness of an Oatmeal Lotion in Improving and Maintaining Barrier Function and Moisture Levels of Moderate to Severely Dry Skin. Poster presented at the 67^th Annual Meeting of the American Academy of Dermatology, March 2009.