MATERIALS AND METHODS
This was a 4-week, single center, randomized, double-blind, split-body study that consisted of the application of Eczema Soothing Moisturizer (Cetaphil® Eczema Restoraderm Soothing Moisturizer, Galderma, Dallas, TX) versus Itch Relief Moisturizing Lotion (CeraVe® Itch Relief Moisturizing Lotion, L'Oreal Active Cosmetics Group, Paris, France). Participants were randomized to apply ESM to the arm/leg on one side and IRML to the other side twice daily, with test sites at the volar forearms and outer lower legs. The study was conducted according to Good Clinical Practice. All participants provided written informed consent prior to the study start.
Patients were eligible to participate if they were healthy adults and had self-perceived mild-to-moderate eczema-prone skin characterized by dryness, itchiness, and flakiness. In addition, they had dry skin determined by test sites on the forearm and leg with corne-ometer measurement <30 au (arbitrary unit) at baseline. Patients were excluded if they had active flaring disease, damaged skin at test sites, a recent skin rash, recently treated skin cancer, or were using immunosuppressive therapy and/or undergoing radiation treatments. All participants agreed to discontinue use of current skincare products (cleansers, lotions, sunscreens) for the duration of the study.
Participants agreed to the following washout periods: 3 days for skincare products; 1-week prior to baseline for anti-inflammatory or antihistamine medications; 2 weeks for acne treatment and topi-cal corticosteroids; 4 weeks for oral corticosteroids, oral antibiotics, and immunosuppressants; and 6 months for oral isotretinoin.
Efficacy assessments included corneometer (Courage and Khazaka, Germany), evaporimeter (Cortex Technology, Hadsund, Denmark), and D-squame® tape stripping (CuDerm®Corporation, Dallas, Texas) at baseline and week 4. Ceramide analysis from the tape strips was analyzed at QIMA Synelvia (Labege, France). In addition, photogra-phy was performed on a subgroup of 10 participants. A question-naire on product attributes, improvements, and overall preference was self-administered at weeks 1 and 4 of treatment. Safety was assessed by collection of adverse events, and evaluation of local skin tolerability.
