Grahams’s Eczema Cream Expert Report

Colloidal Oatmeal – Active ingredient.

Colloidal oatmeal provides a moisturizing and coating barrier on the skin.

Graham’s Eczema Cream is a safe and effective product when used for the relief of eczema, dermatitis and itchy, dry skin. The safety and efficacy of its active ingredient – colloidal oatmeal – has been demonstrated in a number of studies for various indications. These studies have led the FDA to recognize this safety and efficacy of colloidal oatmeal when used in various over-the-counter formulations.

Colloidal oatmeal is produced by the grinding and processing of whole oat grain and the powder contains polysaccharides (60-64%), proteins (13-18%), lipids (3-9%) as well as  enzymes, flavonoids and vitamins.

After such dermal deposition of this ingredient, a colloidal oatmeal plane is formed on the skin and this coating corrects the alkalinity of the tissue exudates as well as the eroding action of clothing on the protective demulcent film. Apart from this skin protecting coating function the formulation moisturizes the skin which contributes to the anti-pruritic efficacy of the cream. This is because the occlusive and water-binding colloidal film holds moisture in the layer, thus improving dry skin conditions.

This moisturizing, coating and barrier function of colloidal oatmeal is claimed as the pivotal mechanism of action of this active ingredient in Graham’s Eczema Cream and which is reflected in the FDA’s recognition as a skin protectant. However, apart from this primary mechanism of action, additional supportive mechanisms have been formulated in recent years in conjunction with the renewed interest in this intriguing active ingredient. These mechanisms include anti-inflammatory and antihistaminic activities as well as ant oxidative activities caused by the presence of avenanthramides in oat grain (Cerio et al, 2010). However, the exact contribution, if any, of these features to the primary coating process as caused by colloidal oatmeal still remains to be validated and is therefore considered irrelevant for the clinical activity of Graham’s Eczema Cream.

This mechanism – moisturizing and cleansing skin barrier protection - complies with EU Medical Device Directive requiring medical devices to have their principal mode of action based on a non-pharmacological, non-immunological and non-metabolic process.

Safety data
The safety of the use of colloidal oatmeal was studied by determining the occurrence of allergy to the product. Sixty five children (6 months to 2 years), atopic or non atopic, with and without previous exposure to colloidal grain suspensions were tested openly for 15 minutes and under patch for 24 hours and 48 hours. The results showed neither immediate allergic reaction in any of the subjects tested. This study together with the long history of use in all age groups and in various dermatitis corroborates the safety of colloidal oatmeal for topical treatments.

In addition to this safety study, clinical studies have not reported any adverse effect associated with the use of oatmeal-based products.

Conclusion
The data presented above allow for the conclusion, beyond reasonable doubt, that Graham’s Eczema Cream is a safe and effective medical device when used for its intended purpose i.e. the relief of eczema, dermatitis and itchy, dry skin. The safety and efficacy of its active ingredient – colloidal oatmeal – has been demonstrated in a number of studies for various indications. These studies have led the FDA to recognize this safety and efficacy of colloidal oatmeal when used in various over-the-counter formulations.