A randomized, controlled, split-face, double-blind comparison of a multimodality pigment-correcting serum containing lotus sprout extract versus hydroquinone for moderate to severe facial hyperpigmentation, including melasma, in a diverse population.

BACKGROUND: Hyperpigmentation results in uneven skin tone, with darker skin types disproportionately affected.

OBJECTIVE: Assess efficacy and safety of a novel, hydroquinone (HQ)-free, multimodal pigment-correcting serum (Advanced Brightening Treatment [ABT]) versus 4% HQ in moderate to severe hyperpigmentation, including melasma.

METHODS: In this split-face study, ABT and 4% HQ were applied topically on randomly assigned facial sides twice daily for 12 weeks. Hyperpigmentation, skin tone evenness, modified Melasma Area and Severity Index (mMASI), Melasma Quality of Life Questionnaire (MelasQoL), self-assessment questionnaires, and tolerability were assessed.

RESULTS: Subjects ( n  = 113; melasma subgroup, n  = 44) were Asian (22%), Black/African American (27%), Hispanic (22%), and White/Caucasian (28%). ABT achieved comparable results to 4% HQ. ABT was well tolerated and resulted in improvement versus baseline at all visits in mean overall hyperpigmentation (-11.7% at week 12; P  ≤ .001), skin tone evenness (-8.8%, P  ≤ .005), and, in the melasma subgroup, mMASI (-50.6%; P  ≤ .011) and MelasQoL scores (33.0 vs 46.6 for week 12 vs baseline, respectively; P  ≤ .011), with similar results across racial subgroups. ABT was preferred over 4% HQ, with high satisfaction rate (≥89%).

LIMITATIONS: Quality of life improvements per treatment were not evaluated separately.

CONCLUSION: Efficacy and safety of ABT is comparable to 4% HQ in individuals with facial hyperpigmentation, including melasma, across multiple racial/ethnic backgrounds.