INTRODUCTION
Facial redness is a common manifestation of cosmetically unattractive inflammation. If the redness becomes persistent and more severe, a diagnosis of rosacea is usually entertained.1 Most individuals with facial erythema possess sensitive skin manifested by a barrier defect, which can allow facial cleansers and moisturizers to reach the viable layers of the epidermis and dermis causing stinging, burning, and/or itching accompanied by worsening facial redness. Formulating skin care products for this population can be challenging, since minor irritation is perceived as major irritation in rosacea sufferers.2 Furthermore, any facial product that induces irritation may produce a resultant rosacea flare.The goal of this research was to examine the moisturizing and redness reducing effect of an anti-inflammatory botanical calm and repair night mask plus cleanser in subjects with mild to moderate facial redness.
METHODS
30 female subjects Fitzpatrick skin types I-IV and 30-55 years of age with mild to moderate chronic facial redness, defined as a redness score of 3-6 on a 10-point scale, were enrolled in this single-site split face study following completion of informed consent and photography consent (Concordia Clinical Research IRB, Beach Haven, NJ). Subjects used a disposable facial wipe (Simple Wipe, Unilever) to wash their face followed by 30 minutes of quiet acclimation prior to assessments. Subjects were screened to insure they met all inclusion criteria and none of the exclusion criteria (Table 1).Evaluations consisted of dermatologist efficacy and tolerability, subject efficacy, and noninvasive assessments. The dermatologist investigator visually assessed by the subjects for the following efficacy criteria on a 10-point scale (0=none to 9=extremely severe): erythema, capillaries, blotchiness, scaling, flaking, tactile smoothness, textural smoothness, firmness, radiance, luminosity, and overall appearance. Each side of the face was separately assessed to allow each subject to act as their own control. The investigator also assessed the following tolerability criteria separately for each side of the face on a 5-point scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe): erythema, desquamation, stinging, burning, and itching. Noninvasive assessments were performed as follows:1. Corneometry (Pin probe, Dermalab Combo, Cortex Technologies, Hadsund, Denmark): 2 duplicate touch readings were made over the right and left cheeks.2. D-Squames (CuDerm, Dallas, TX): One tape strip was obtained from a predefined target spot on the lateral right and left cheeks for skin exfoliation analysis.Finally, Visia CR-4.3 photographs (Canfield, Parsippany, NJ) of the center, right, and left face were performed on selected subjects to document differences between the two sides of the face during the 4-week study. Following completion of all baseline assessments, subjects were dispensed a cleanser for full facial washing twice daily for 7 days (Foaming Oil Cleanser, SkinFix, Halifax, NS). Subjects were randomized to apply a dime-sized amount of the study mask only to one side of the face at bedtime, leaving the untreated side as a control. Every attempt was made to enroll subjects with symmetrical
