J. Cosmet. Sci., 66, 295–303 (September/October 2015) 295 Equivalence evaluation of moisturizers in atopic dermatitis patients MAI TAMURA, HIROSHI KAWASAKI, TAKUJI MASUNAGA, and TAMOTSU EBIHARA, Department of Dermatology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo 160-8582 (M.T., H.K., T.E.), and Fundamental Research Laboratories, KOSÉ Corporation, 1-18-4, Azusawa, Itabashi, Tokyo 174-0051 (T.M.), Japan. Accepted for publication June 26 2015. Synopsis Skin care with moisturizers to compensate for dry skin and decreased barrier function, and to prevent recur- rence of infl ammation is thought to be very important for management of atopic dermatitis. However, many patients cannot continue the use of moisturizing medications because of unpleasantness. Cosmetics may be able to compensate for such defi ciencies. To evaluate the usefulness of cosmetics in maintenance of the skin in remission, we conducted a clinical trial using moisturizing cosmetics of a phospholipid preparation that showed good moisture-retaining effect in dry skin. The utility of moisturizing cosmetics was evaluated by skin fi ndings, subjective symptoms, adverse events, moisture content of the st ratum corneum, tr ansepider- mal water loss (TEWL), and a questionnaire on feel of use in comparison with a heparinoid preparation as a control product. Degree of improvement in skin fi ndings, dryness and de squamation score, pruritus score, TEWL, and moisture content were nearly the same as with the control product. The result indicated that the moisturizing cosmetic was of equivalent effect compared with the heparinoid control preparation. INTRODUCTION Atopic dermatitis (AD) is defi ned by the presence of pruritic eczema lesions with re- peated remissions and exacerbations following a chronic course with diverse nonspecifi c stimulant reactions and specifi c allergic reactions due to physiological disorders of the skin, including skin dryness and barrier function abnormalities, arising from dysfunction of the stratum corneum. Considering the pathophysiology of AD, skin care with moisturizers to compensate for dry skin and decreased barrier function and to prevent recurrence of infl ammation is thought to be very important for addressing physiological abnormalities of the skin. The Guidelines for the Management of Atopic Dermatitis by the Japanese Dermatological Association also state the need for skin care with topical agents that do not include Address all correspondence to Tamotsu Ebihara at ebitamo@z6.keio.jp.

JOURNAL OF COSMETIC SCIENCE 296 steroids or immunosuppressants (1). These topical agents include petroleum jelly, urea ointment, ointments containing heparinoid substances, zinc oxide ointment, and hydro- philic ointments. In 2007, Kawashima et al. (2) compared dermatitis relapse rates between a group of AD patients in remission who received a moisturizer (preparations containing heparinoid substances) and an untreated control group, showing that relapse of dermatitis could be prevented by topical application of the moisturizer. Preparations containing heparinoid substances are widely used as a treatment for dry- ness in AD patients during remission, but many patients stop using these preparations for reasons such as unpleasantness of use, smell, or tactile feel of these moisturizing medications. As a result, infl ammation recurs. Compliance with topical medications in remission periods is thus an issue in the treatment of AD. We therefore focused on how to continue the use of moisturizer in AD patients and thought that patient compliance could be improved using cosmetics that have moisture-retaining properties and are pleasant to use and offer a good tactile feel, and that this may lead to better quality of life (QOL) for patients by maintaining remission and controlling the skin condition. Cosmetics generally show moisture-retaining properties, and a variety of tactile feels suited to individual preferences can be obtained. Cosmetics with good texture also have the characteristic that they are more likely to be used over long term. Cosmetics may be able to compensate for the defi ciencies of preparations with heparinoid substances, and are worth considering in the maintenance of remission phase of AD. Furthermore, the concept that skin care using moisturizer contributes to the prevention of not only AD but also other allergies, including food allergy or asthma, is widely accepted (3). Such moisturizing cosmetics as mentioned above are also suitable to use for allergy preventing skin care. A test preparation was formulated from the perspective of pleasantness of use, tactile feel, easy to apply, and spreadability. Preparations with good moisture-retaining effects were also desired, so phospholipids were selected on the basis of the good moisture-retaining effects in dry skin diseases (4–6). We conducted a clinical evaluation of the effi cacy of such a cosmetic with moisture-retaining effect in a randomized single-blind trial, and reported the results herein. MATERIALS AND METHODS This study was approved by the ethics committee at Keio University School of Medicine, Tokyo, Japan, on February 25, 2009, and was conducted from March 9, 2009 to April 19, 2010. SUBJECTS Subjects comprised AD patients examined in the Department of Dermatology at Keio University Hospital, who met the following inclusion criteria. Inclusion criteria: subjects were taken from AD patients in remission (age, 20 to 65 years), in whom infl ammation had subsided, in whom sites with main symptoms of dry- ness were present, and in whom the use of a moisture-retaining agent was considered appropriate.