Hydroquinone-free Skin Brightener System for the Treatment of Moderate-to-severe Facial Hyperpigmentation.
OBJECTIVE
To evaluate the efficacy and tolerability of a multimodal skin-brightening regimen in subjects with facial hyperpigmentation.


METHODS
Open-label, single-center clinical study with clinical assessments at baseline, Week 4, Week 8, and Week 12.


METHODS
Subjects were instructed to apply the skin-brightening complex onto their facial skin, twice daily, for 12 weeks. Subjects also applied a nonprescription retinol product, moisturizer, and sunscreen.


METHODS
Twenty-one subjects, aged 41 to 65 years, with Fitzpatrick skin types II to IV and moderate-to-severe facial hyperpigmentation completed the study.


METHODS
Overall hyperpigmentation and tolerability (objective and subjective) assessments were conducted at all visits. In addition, global improvement in hyperpigmentation was assessed at all follow-up visits. A self-assessment questionnaire was completed by subjects at Week 12.


RESULTS
At baseline and Weeks 4, 8, and 12, subjects were assessed for overall hyperpigmentation and global improvement. Standardized digital photographs were also taken of the subjects' facial skin at all visits. Subjects completed a self-assessment questionnaire at Week 12. Statistically significant reductions in mean Overall Hyperpigmentation scores and significant improvements in mean Global Improvement scores compared to baseline were observed at all follow-up visits (all p<0.001). These clinical observations were supported by standardized digital photography. In addition, the skin-brightening regimen was highly rated by subjects on all of the questionnaire parameters.


CONCLUSIONS
The results from this study suggest that the multimodality skin-brightening regimen may provide a comprehensive and optimal treatment option to help reduce facial hyperpigmentation.
Thomas J. Stephens & Associates, Carrollton, Texas.
James H
JH
Herndon
Thomas J. Stephens & Associates, Carrollton, Texas.
Elizabeth T
ET
Makino
Thomas J. Stephens & Associates, Carrollton, Texas.
Thomas J
TJ
Stephens
SkinMedica Inc., an Allergan Company, Carlsbad, California.
Rahul C
RC
Mehta