Gary Grove1, Charles Zerweck. 1. Skin Study Center, Broomall, Pennsylvania 19008-4204, USA. kglssc@bellatlantic.net
Abstract
An open-label, single-center, observer-blinded, controlled trial was conducted during the winter months to evaluate the moisturizing and antipruritic effects of a unique formulation of lactic acid 12% neutralized with ammonium hydroxide and pramoxine hydrochloride (HCl) 1% in 24 women with a history of dry itchy skin. Baseline assessments for appearance of dryness of both lower legs of each patient were conducted by a blinded expert grader; skin surface hydration was measured by the IBS Co, Ltd, Skicon-200 (Hamamatsu, Japan) conductivity meter; and dryness and itch were measured through self-assessment surveys. The women stopped the use of all moisturizing agents 7 days prior to and throughout the study and were allowed to use only a nonmoisturizing soap for bathing and shaving. Patients were randomized as to which leg to apply the test cream; the opposite leg was used as a nontreated control. Patients applied the test product liberally to the assigned leg twice daily for 7 days and had repeat assessments for appearance and hydration on the morning of days 3 and 7; self-assessments of itch and dryness were completed on days 1, 2, 3, 6, and 7. Expert grader assessment of skin dryness showed significant improvement with the test cream compared with no treatment on day 3 (P=.0004) and on day 7 (P<.001). Patients had statistically significant improvement in skin surface hydration by day 3 (P<.0001), with further improvement by day 7 (P<.0001). Patients also reported significant improvements in skin dryness and itch by day 1 (P<.0001 and (P<.0001, respectively), which continued to improve through day 7 (P<.0001 and P<.0001, respectively). In conclusion, the test cream was shown to be an effective moisturizer and antipruritic agent in treating dry itchy skin.
RCT Entities:
An open-label, single-center, observer-blinded, controlled trial was conducted during the winter months to evaluate the moisturizing and antipruritic effects of a unique formulation of lactic acid 12% neutralized with ammonium hydroxide and pramoxine hydrochloride (HCl) 1% in 24 women with a history of dry itchy skin. Baseline assessments for appearance of dryness of both lower legs of each patient were conducted by a blinded expert grader; skin surface hydration was measured by the IBS Co, Ltd, Skicon-200 (Hamamatsu, Japan) conductivity meter; and dryness and itch were measured through self-assessment surveys. The women stopped the use of all moisturizing agents 7 days prior to and throughout the study and were allowed to use only a nonmoisturizing soap for bathing and shaving. Patients were randomized as to which leg to apply the test cream; the opposite leg was used as a nontreated control. Patients applied the test product liberally to the assigned leg twice daily for 7 days and had repeat assessments for appearance and hydration on the morning of days 3 and 7; self-assessments of itch and dryness were completed on days 1, 2, 3, 6, and 7. Expert grader assessment of skin dryness showed significant improvement with the test cream compared with no treatment on day 3 (P=.0004) and on day 7 (P<.001). Patients had statistically significant improvement in skin surface hydration by day 3 (P<.0001), with further improvement by day 7 (P<.0001). Patients also reported significant improvements in skin dryness and itch by day 1 (P<.0001 and (P<.0001, respectively), which continued to improve through day 7 (P<.0001 and P<.0001, respectively). In conclusion, the test cream was shown to be an effective moisturizer and antipruritic agent in treating dry itchy skin.