Individual Article: Efficacy of Over-The-Counter Cream in Reducing Eczema Signs
October 2023 | Volume 22 | Issue 10 | SF388641s5 | Copyright © October 2023
Published online September 30, 2023
Adelaide A. Hebert MDa, Mathieu Grivet-Seyve PhDb, Sarah Anjuwon MSb, Nathalie Piccardi PhDc, Nadège Lachmann PhDd, Agustin Cruz MDe, Christine Emesiani PharmD
aUTHealth McGovern Medical School, Houston, TX
bGalderma R&D, Dallas, TX
cGalderma R&D, Lausanne, Switzerland
dGalderma Sensitive Skincare Faculty, Lausanne, Switzerland
eGalderma Laboratories, L.P., Dallas, TX
Abstract
Background: Eczema (also called atopic dermatitis) is a chronic, relapsing skin disease characterized by erythema, scaling, and pruritus.
Methods: Study 1. A double-blind, uncontrolled study in patients with mild-moderate eczema, ≥2 flares in prior 2 months, and baseline Scoring Atopic Dermatitis (SCORAD) score ≤15. Participants applied Eczema Flare-Up Relief Cream (EFRC) (N=65) BID for 56 days. Efficacy was assessed by SCORAD, patient-oriented SCORAD, skin sensitivity, Dermatology Life Quality Index (DLQI), and digital photography. Standard safety assessments were performed. Study 2. A 21-day open study of EFRC (N=50) to evaluate tolerability as well as its effect on eczema.
Results: Study 1. EFRC significantly reduced overall SCORAD scores from baseline to day 56 (11.6 to 4.9, or a 57% reduction). The patient-oriented SCORAD was reduced from 18.6 to 6.8 from baseline to day 56. At day 56, itch and pain improved in 70.4% of children and 62% of adults. DLQI scores were decreased by 75% in adults and 61% in children by day 56. Global skin sensitivity, assessed by the Sensiscale 10-item questionnaire, was 13.1 at baseline and 3.6 at day 56, an improvement of 72%. Study 2. EFRC improved eczema-prone skin after 7 and 21 days.
Conclusions: Study 1 showed that EFRC had good efficacy with significant reductions in overall SCORAD scores and subscores for the extent and intensity of eczema and subjective symptoms. Skin sensitivity also improved along with quality of life. Studies 2-3 also had significantly positive results and good tolerability.
J Drugs Dermatol. 2023;22:10(Suppl 2):s5-9.
INTRODUCTION
Eczema affects approximately 31 million people in the United States and is characterized by dryness, itchiness, scaling, roughness, irritation, or discoloration as well as periodic unpredictable flares.1 Developing a good skincare regimen, including the use of moisturizing creams targeted to eczema-prone skin can reduce the likelihood of flares.4 Cetaphil® Eczema Flare-up Relief Cream (EFRC) was specially developed to help repair damaged skin barrier, relieve uncomfortable symptoms, and reduce flare occurrence of those with eczema and eczema-prone skin.
MATERIALS AND METHODS
Study 1: Efficacy Clinical Trial
This was a multi-center (USA, Ukraine, and Georgia), double-blind, uncontrolled comparison study in patients aged 4 to 60 years with mild-to-moderate eczema and sensitive skin, a SCORAD score between 15 and 40 at screening and <15 at baseline visit, and at least 2 flares in the 2 months prior to screening. Patients applied EFRC twice daily on the face and body and were allowed to use hydrocortisone as needed for flare. All patients or parents provided written informed consent, and the study received ethics committee approval and was conducted in accordance with Good Clinical Practice.
