The clinical appearance of AV was assessed at baseline and over the 12-week study period using an Investigator Global Assessment (IGA) Scale (Table 1). To enroll into the study, the participant needed to be ≥age 18 years and exhibit a baseline IGA for facial AV of 1 or 2. Standard inclusion and exclusion criteria for AV studies were utilized and participants needed to fully complete Informed Consent after appropriate education on the study protocol and after having all their questions answered. Females who were pregnant, nursing, or who stated they are planning to become pregnant were excluded as were patients with allergy or hypersensitivity to AV treatments or dermatologic and/or medical disorders that the investigator felt made the patient unsuitable for enrollment. Standard washout periods for AV study inclusion were used for systemic therapies, topical therapies, and facial procedures. Participants were discontinued from the study if a new study exclusion, significant intercurrent illness, or a major adverse event (AE) occurred, or if the participant chose to voluntarily withdraw. Every reasonable attempt was made to ascertain the reason(s) for participant withdrawal. The study was completed following recognized industry standards and good clinical practice.
Test Articles and Application Instructions
The ingredient lists for CGCAC AND CGCAM are depicted in Table 2. Both formulations contain salicylic acid. Participants were instructed to use the test articles according to the following instructions:
Step 1: Cleanser: Every morning and evening (before bedtime), apply to dampened skin and gently massage, avoiding the eye area. Rinse thoroughly and pat dry.
Step 2: Moisturizer: Every morning and evening after using the cleanser, apply moisturizer as a thin layer over the entire face.
Step 3 (Optional): Photoprotection. Use of Cetaphil Daily Facial Moisturizer SPF 35 (Galderma) as needed whenever sun exposure was anticipated, especially more prolonged exposure.
