Effectiveness and Safety of Topical Under-eye Serum in Patients with Periorbital Hyperpigmentation: An Open-label Single Arm Prospective Study.

OBJECTIVE

We sought to determine the efficacy and safety of a topical under-eye serum (Melalumin™; Menarini India Pvt Ltd.) in patients with periorbital hyperpigmentation (POH).

METHODS

In this prospective, open-label single-arm study, 90 patients aged 18 to 55 years with Grade I to IV pigmentary POH, were given the under-eye serum for three months. Follow-up visits were scheduled at one, two and three months from baseline. Effectiveness was evaluated by two independent dermatologists using a skin colorimeter (Dermacatch) and dermoscopy (FotoFinder Systems, Inc., Medical Imaging Systems; Columbia, Maryland), as well as global photographs and patient-reported satisfaction ratings (excellent, very good, good, not satisfied). Adverse events were recorded. The colorimeter values were evaluated using the paired T test and the single-mean T test was used for dermoscopy and global clinical photographs.

RESULTS

Of the 90 patients included, 85 completed the study. Significant reductions in colorimeter values were noted in both melanin (from 708 to 621) and erythema (from 450 to 417) over three months (<0.05). Mean improvement in dermoscopic assessment was 48.41 percent; Most (n=73/85; 85.88%) patients achieved >25-percent improvement; over one-third (n=31/85; 36.47%) showed >50-percent improvement. Global photographs improved by 49.47 percent; most (n=75/85; 88.24%) patients showed >25-percent improvement, over one-third (n=38/85; 44.71%) showed >50-percent improvement. Patient satisfaction levels were high (Excellent: 16 [18.82%]; Very good: 38 [44.71%]); Good: 26 [30.59%]; Not satisfied: 5 [5.88%]). No adverse events were noted.

CONCLUSION

This study demonstrates safety and effectiveness of the studied under-eye serum in patients with pigmentary POH. In addition to clinical improvements noted by the investigators, significant improvements were also noted in colorimeter values, dermoscopy results, and global photographs. Patients exhibited high satisfaction levels with treatment outcomes. No safety concerns were noted.