Facial photodamage was assessed using an overall integrated score (range 0-6, where 0=none and 6=severe). Individual photodamage characteristics were reported, including lentigines, tactile roughness, laxity, mottled hyperpigmentation, fine wrinkling, coarse wrinkling, and crepiness (range, 0-5, where 0=none and 5=very severe). Full-face images were taken of each prospective subject using the VISIA CR (Canfield Imaging Systems, Fairfield, NJ). The above-mentioned outcome measures were evaluated at baseline and weeks 4, 8, 12, 18, and 24; except the melasma improvement assessment (which was not evaluated at baseline). Adverse events (AEs) were recorded, if applicable throughout the study. Statistical Analyses
Changes from baseline in efficacy parameters of melasma disease severity, melasma pigmentation intensity, MASI, overall integrated photodamage, individual photodamage attributes of lentigines, tactile roughness, laxity, mottled hyperpigmentation, fine wrinkling, coarse wrinkling, and crepiness were evaluated using paired t- tests. An α of ≤0.05 was considered statistically significant.
RESULTS
The study was conducted between November 2014 and June 2015.
Patients
Overall 38 patients were enrolled in the study and 31 (81.6%) completed the study. Three subjects requested withdrawal, two were discontinued due to noncompliance and two were lost to follow-up but included in the Intent-to-Treat [ITT] Population. Patients had a mean age of 50.8 years old with 33.3% Asian (11/33), 27.3% Hispanic or Latino (9/33), 24.2% (8/33) Black or African American, 12.1% (4/33) Caucasian, and 3.0% (1/33) Pacific Islander. They had Fitzpatrick skin types of III (51.5%), IV (21.2%), V (24.2%), or VI (3.0%).No patient discontinued the study due to lack of efficacy or adverse event.At baseline, mean melasma disease severity and pigmentation intensity scores were moderate [4.27 (±0.94) and 4.88 (±1.39), respectively]. The MASI was 15.32 (±6.87) and overall integrated facial photodamage score was mild-to-moderate
