A Prospective, Randomized, Controlled Double-Blind Study of a Moisturizer for Xerosis of the Feet in Patients with Diabetes

  • Wed, 9/3/08 - 10:25am
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Author(s): 
Hau Trung Pham, DPM; Lois Exelbert, RN, MS, ACCE, CDE; Arlynn Carole Segal-Owens, RN, BSN, MSPH, CDE; and Aristidis Veves, MD

T he loss of moisture from the stratum corneum and intercellular matrix leads to dry skin, or xerosis. Clinically dry skin appears rough, uneven, and cracked. Raised or uplifted skin edges (scaling), desquamation (flaking), chapping, and pruritus may be present. A person who has a decrease or loss of function of the sweat glands on the plantar surface of the foot will experience xerosis of the feet.

Xerosis of the feet is a skin condition found in all age groups but can be aggravated by certain conditions. The incidence of xerosis increases with age, exposure to dry environmental conditions, and physiological changes that alter circulatory supply to the lower extremities. People with diabetes have a high incidence of xerosis of the feet, especially on the heels. While assessing for predictors of foot lesions in patients with diabetes, one study found that 82.1% of their patients had skin with dryness, cracks, or fissures.1 An unpublished survey of 105 consecutive patients with diabetes conducted by one of the authors revealed that 75% had clinical manifestation of dry skin. Dry skin often leads to cracks and fissures, which can serve as a portal of entry for bacteria. These cracks and fissures are associated with an increased risk of cellulitis and foot ulceration2,3 that, if left unchecked, can eventually lead to amputation. The importance of examining patients' feet and offering instruction in preventive foot care by physicians and diabetes educators is often overlooked.

Xerosis can be controlled with moisturizers. The common ingredients often found in these products are urea and lactic acid; both are natural moisturizers. Urea was found to be a potent skin humidifier and descaling agent, particularly in 10% concentration.4 Urea-containing moisturizers work by decreasing transepidermal water loss.5 The lactic acid in moisturizers is in the form of alpha hydroxy acid (AHA). Alpha hydroxy acid is an exfoliating agent of the epidermis that sloughs off the dry skin cells and promotes the new growth of skin. Lactic acid also serves as a good humectant, retaining water in the stratum corneum; it also increases the extensibility and elasticity of the stratum corneum protein.6 Kempers et al7 found moisturizers containing AHA lead to significantly greater improvement in xerosis than non-AHA containing moisturizing lotion. However, at high concentrations, AHA may cause skin irritation and redness. Many over-the-counter moisturizers containing either urea or lactic acid are available. A moisturizer containing ammonium lactate 12% (Lac-Hydrin™, Westwood-Squibb Pharmaceuticals Inc., Buffalo, NY) has been approved by the FDA for treatment of dry, scaly skin and is available by prescription only. Carmol™ (Doak Dermatologics, Fairfield, NJ) is also available by prescription in creams with 10%, 20%, or 40% urea. Several studies demonstrate the efficacy of some moisturizers,8-11 but none of the published studies involved the feet of patients with diabetes.

The purpose of this study was to evaluate the safety and efficacy of a moisturizer containing 4% lactic acid and 10% urea in the treatment of severe xerosis of the feet in patients with type 1 or type 2 diabetes.

Study Design

A prospective, randomized, controlled double-blind study design was used to compare the treatment of xerosis with a moisturizer containing 10% urea and 4% lactic acid in an emulsion base to a moisturizer containing the emulsion base only.

References: 

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