Efficacy of a tailored moisturizer for reducing chemotherapy-induced skin dryness in breast cancer patients: A randomized controlled clinical trial
We designed a single-center, randomized controlled trial to test the efficacy of a tailored moisturizer with a high content (1.5%) of pseudo-ceramides that mimics natural ceramides which comprises more than 50% of skin lipids for managing chemotherapy-induced dryness. Breast cancer patients experiencing skin dryness after 1 cycle of chemotherapy were randomized in a 1:1:1 ratio to receive tailored moisturizer; general moisturizer; and usual care from February 2015 to October 2018 at the Samsung Medical Center in South Korea. Patients assigned to tailored or general moisturizer group were asked to apply the moisturizer twice a day from the first day of 2nd cycle of chemotherapy until 1 month after completion of chemotherapy. While usual care group (UCG) was not blinded, the general moisturizer group (GMG) was blinded. Since our intervention was tailored moisturizer for the face, the primary outcome was severe skin-dryness on the face at 1 month after completion of chemotherapy. Severe skin-dryness on face was defined as a response to severe or very severe dryness in Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. For the secondary outcomes, sebum and water content were measured on the front of the right cheek using a Multi-Probe Adapter System. We also assessed skin dryness and dullness on their face using a 10-point visual analog scale and impairment of dermatological QoL using Dermatology Life Quality Index. The TMG reported lower levels of skin dullness (3.1 vs. 4.6 vs. 4.4) and impairment of dermatological QoL (2.0 vs. 4.8, 3.9) than UCG and GMG respectively. In addition, sebum content in the UCG and GMG were lower at 3 weeks (1.33 vs. -3.05, P < 0.01 vs. -2.11, P = 0.04) and at 1 month after completion of chemotherapy than these of TMG (0.77 vs.-2.64, P = 0.04 vs. -0.96, P = 0.31). Water content showed similar patterns but the differences across the groups were not significant. In conclusion, we demonstrated a tailored moisturizer improved patient reported skin dryness and dullness on face and dermatological QoL compared to usual care in breast cancer patients undergoing chemotherapy. Further studies with larger sample are necessary to confirm the effects on objective skin parameters including epidermal water loss.