An Open-Label Study Assessing the Efficacy and Tolerability of a Skincare Regimen in Subjects of Different Ethnicities with Moderate-to-Severe Hyperpigmentation

Background: Hyperpigmentation is a common cosmetic concern that significantly impacts self-esteem. A skincare regimen has been developed to improve the appearance, tone, texture, and luminosity of subjects with facial hyperpigmentation (Even Up^® Hyperpigmentation Regimen; Colorescience, Inc., Carlsbad, CA).

Aims: The objective of this open-label trial was to assess the efficacy and tolerability of this regimen for treating facial hyperpigmentation.

Patients/methods: Subjects with moderate-to-severe facial hyperpigmentation (N = 33) were randomized to those not using prescription, advanced or physician-dispensed skin care products (Group A, n = 23) and those currently using prescription, advanced or physician-dispensed skincare products for facial hyperpigmentation (Group B, n = 10). Both groups were provided three skincare products comprising the hyperpigmentation regimen and instructions for use. Subjects were evaluated at baseline and Weeks 2, 4, 8 and 12.

Results: The overall median (range) baseline MASI score at baseline was 9.0 (2, 31), decreasing by 0.0 (-7, 0) points at Week 2 (p = 0.002), 0.6 (-8, 0) points at Week 4 (p < 0.0001), 1.5 (-16, 0) points by Week 8 (p < 0.0001) and 2.4 (-20, 0) points at Week 12 (p < 0.0001). At Week 12, the overall median improvement in MASI score was 26% and higher for Group B (32% vs. 22%). By Week 2, subjects reported lighter, less noticeable brown spots (76%), brighter, more luminous skin (88%), more even skin tone (67%), and healthier look and feel (85%). Improvements continued throughout the study. No adverse events were observed or reported.

Conclusions: This regimen addresses facial hyperpigmentation and protects skin against the damaging effects of ultraviolet and high energy visible light (HEV). It is safe to use on all skin types and tones.

Fitzpatrick skin types; hyperpigmentation; melasma; mineral sunscreen; solar lentigo.