Journal of Clinical and Aesthetic Dermatology

APR 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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32 JCAD journal of clinical and aesthetic dermatology April 2017 • Volume 10 • Number 4 o R i g i n a l R E s E a R C h Subject screening and enrollment. Thirty-one subjects were enrolled. Men and women over 18, but not more than 75 years of age, were included. Patients who have a regularly scheduled dermatology appointment for augmentation of their facial wrinkles were eligible for the study. The authors excluded any subject who had a previous history of allergy, sensitivity, and contraindication to benzocaine, lidocaine, and tetracaine. Patients with cardiac/respiratory disease, seizure disorder, and neuropathies, as well as patients who were under treatment for a dermatologic condition that may interfere with the evaluation of the study were also excluded. Pregnant women and women who were breastfeeding were excluded from the study. Women of childbearing potential were given a urine pregnancy test performed by members of the investigator team. Patients who reported concurrent use of anxiolytics and opiates, which may interfere with the interpretation of results, were excluded from the study. After agreeing to the consent form, these patients were enrolled in the study. Procedure, questionnaire, and assessments. Participants were randomized to receive two types of BLT creams in a split-face fashion to two opposite anatomical face locations that require a similar amount of filler. Subjects were blinded to the type of BLT applied to each side of the face. One member of the team, the blind evaluator, was blinded to the site to which each type of BLT was applied. The study team applied BLT cream according to identification (ID) numbers chosen for each subject. Subjects with even numbered IDs had BLT with abrasives applied to the right of the face, and subjects with odd number study IDs had BLT with abrasive particles applied to the left side of the face. Both types of the cream were concurrently applied for 30 minutes to the designated treatment areas in a uniform thickness of approximately 1mm. After the face had been completely cleansed of BLT cream, the area was evaluated by the study team for signs of edema and erythema. A small 30- gauge needle point was used by the investigator to probe the level of the pain or discomfort. Subjects then received injections of HA by beginning with right nasolabial fold. Upon first needle stick and upon completion of the injections at each site, subjects were asked to evaluate their pain and discomfort by using VAS and Wong-Baker Face Pain Rating Scale. OUTCOME MEASUREMENTS The subjects completed the VAS by drawing a single vertical line through a 10cm horizontal line. Following the completion of the study, the distance from the furthest left vertical axis (no pain) of the scale and the patient's VAS mark was measured in millimeters by using a ruler. Furthermore, patient's pain assessment was performed by using Wong-Baker Face Pain Rating Scale. This scale shows a series of faces ranging from a happy face at "no hurt" (0) to a crying face at "hurts worst" (10). At the same time, the VAS measurement was performed. STATISTICAL EVALUATION The authors evaluated the difference in the pain scale results between both types of BLT creams. All analyses were performed by SPSS version 13.0 (SPSS, Inc., Chicago, Illinois). Descriptive statistical analysis was used and differences among the mean pain levels as measured by the VAS and Wong-Baker Face Pain Rating Scale were analyzed by using the paired t-test. RESULTS Of the 31 subjects enrolled in the study, 28 (90%) were female. The mean age of the patients studied was 54 years old. More than half of subjects had a skin type of II or III (Table 1). Table 2 shows a statistically significant difference (P<0.05) in the mean pain level as measured by the VAS and Wong-Baker Faces Pain Rating Scale when compared between baseline and the time when the procedure was started at the first needle stick. Subjects expressed significantly less pain with baseline and more pain when the procedure was done. However, the authors found that the mean pain level at first needle stick is lower with the abrasive type of BLT. Table 3 shows the results when the authors compared the two groups of BLT—smooth versus abrasive creams. Although the application duration, area, and type of HA injection were identical in

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