Dry skin affects nearly everyone at some point in their lifetime. Many emollients are available in products designed to soothe and relieve itchy, dry skin. However, few controlled experiments have been published comparing the efficacy of the active versus the vehicle used to deliver the products to the skin.
Pivotal Study
A Randomized Controlled Clinical Study to Evaluate the Effectiveness of an Active Moisturizing Lotion with Colloidal Oatmeal Skin Protectant Versus Its Vehicle for the Relief of Xerosis1 Clinical study to evaluate the effectiveness of an AVEENO® Colloidal Oatmeal Lotion versus its vehicle for the relief of xerosis as published in Journal of Drugs in Dermatology 2014
Purpose
Objectively compare the efficacy of a commercially available moisturizing product against its vehicle for relief of skin dryness in a randomized, controlled clinical study. Key Emollients and Skin Conditioners in products tested: Colloidal Oatmeal Lotion : Oat Flour, Oat Extract, Oat Oil, Dimethicone, Water, Glycerin, Petrolatum, Shea Butter Vehicle: Dimethicone, Water, Glycerin, Petrolatum, Shea Butter
Design
20 women
18-70 years old
3 week study, 1 week regression
Double-blinded, split leg, controlled study where patients used both products. Instrumental measurements of hydration (Corneometer, SkiCon), imaging, clinical and patient assessments were conducted at baseline, after 21 days of treatment and after a 1-week regression period without treatment.
Results
Study showed significantly greater efficacy of AVEENO® Colloidal Oatmeal Lotion versus its vehicle Clinical grading showed AVEENO® Colloidal Oatmeal Lotion had significantly greater improvements in scaling, overall dryness, and intensity, duration and frequency of itch and significantly better hydration as measured by the Corneometer and Skicon at 21 and again at 28 days (after the 1-week regression).
Figure 1: Performance Table
Change in Skin Hydration Measurements:
Figure 2: CLINICAL GRADING Table
Figure 3: INSTRUMENTAL MEASUREMENTS Table
*Significant improvement (p<0.05) with the AVEENO® Colloidal Oatmeal Lotion when compared to vehicle after 21 days of treatment
9 out of 10 patients preferred AVEENO® Colloidal Oatmeal Lotion over its vehicle
Figure 4: Patient Ratings Table
This robust, controlled clinical study shows the benefits of colloidal oatmeal in significantly improving scaling, dryness and itch in patients with moderate to severe xerosis.
REFERENCES 1. Kalaaji AN, Wallo W. A randomized controlled clinical study to evaluate the effectiveness of an active moisturizing lotion with colloidal oatmeal skin protectant versus its vehicle for the relief of xerosis. J Drugs Dermatol. 2014 Oct;13(10):1265-8. PMID: 25607563. ©Johnson & Johnson Consumer Inc., 2021