A 1% Colloidal Oatmeal Cream Alone is Effective in Reducing Symptoms of Mild to Moderate Atopic Dermatitis: Results from Two Clinical Studies
July 2017 | Volume 16 | Issue 7 | Original Article | 671 | Copyright © July 2017
Toni Anne Lisante BA,a Chris Nunez PhD,b Paul Zhang PhD,c and Barbara M. Mathes MDd
aGlobal Scientific Engagement, Johnson & Johnson Consumer Inc., Skillman, NJ bMedical Affairs, Johnson & Johnson Consumer Inc., Skillman, NJ cBiostatistics, Johnson & Johnson Consumer Inc., Skillman, NJ dDepartment of Dermatology, University of Pennsylvania, Philadelphia, PA
BACKGROUND: The epidermal barrier in patients with atopic dermatitis (AD) is deficient in ceramides and cathelicidins. Such epidermal defects may be a trigger for AD, thereby encouraging research toward development of skin-barrier-targeted preventive strategies.
METHODS: Two single-center, single-arm clinical trials were conducted (study 1, age greater than equal to 8 years and study 2, greater than equal to 10 years) in patients with mild to moderate AD to evaluate the effects of an over-the-counter 1% colloidal oatmeal cream administered for 14 days. Study 1 assessed the Eczema Area and Severity Index (EASI) and Investigator’s Global Atopic Dermatitis Assessment (IGADA) on day 3, and itch severity using a Visual Analogue Scale (VAS) immediately after application as primary efficacy endpoints. In study 2, the primary efficacy endpoint was change from baseline in patients’ assessment of itch. Both studies assessed safety through adverse event (AE) recording.
RESULTS: Study 1: 29 patients were enrolled (mean age [range], 27.07 [8 –67]). Comparing to baseline, EASI, IGADA, and itch were improved after the application, and improvements were maintained until day 14. Improvements of greater than/equal to 20% over baseline were noted in 53.6% and 25.0% patients at day 3 for EASI and IGADA scores, respectively, and in 37.9% patients for itch score immediately after the product application. On day 14, these percentages were 82.8%, 62.1%, and 85.7%, respectively.
STUDY 2: 30 patients were enrolled (mean age [range], 32.9 [10-80]). Itch severity and EASI score were significantly improved after product application and improvements were maintained until day 14. Transepidermal water loss values were significantly reduced and skin hydration was significantly increased at all assessment time points. No adverse events (AEs) were reported in study 2 and 2 AEs were reported by 1 patient in study 1.
CONCLUSIONS: The colloidal oatmeal cream was well tolerated and clinically effective in patients with mild to moderate AD.
J Drugs Dermatol. 2017;16(7):671-676.