In Vitro and In Vivo Efficacy and Tolerability of a Non-Hydroquinone, Multi-Action Skin Tone Correcting Cream

July 2019 | Volume 18 | Issue 7 | Original Article | 642 | Copyright © July 2019

Pearl E. Grimes MD,a David H. McDaniel MD,b Mitchell Wortzman PhD,c Diane Nelson RN MPHc

aVitiligo & Pigmentation Institute of Southern California, Los Angeles, CA

bMcDaniel Institute of Anti-Aging Research, Virginia Beach, VA

cskinbetter science LLC, Phoenix, AZ 

Treatment Group 2
(ETCS + AHA-Ret, n=10)
Subjects using combination treatment of ETCS + AHA-Ret demonstrated significant mean percent reductions from baseline for dyschromia at all timepoints (P<0.0001, each) with 21%, 38% and 44% reductions occurring at 4, 8, and 12 weeks, respectively (Figure 5). More than half of the subjects (55%) achieved at least a ≥1-grade improvement in dyschromia at 4 weeks. Significant mean percent reductions from baseline for melanin index were achieved in subjects at all timepoints (week 4, P<0.02; weeks 8 and 12, P<0.0001; Figure 6), with 8%, 16%, and 20% mean reductions from baseline at 4, 8, and 12 weeks, respectively. Subjects also achieved significant mean percent improvements at 12 weeks in the appearance of fine lines/wrinkles, skin texture, and global improvement (Table 1; Figure 7).At 16 weeks, subjects demonstrated significant mean percent reductions from baseline for dyschromia (52%, P<0.0001) and melanin index (24%; P<0.0001) with combination use of ETCS + AHA-Ret. Significant mean improvements from baseline were also demonstrated at 16 weeks in subjects in the appearance of erythema (52%; P<0.02), skin texture (34%; P<0.0017), and fine lines/wrinkles (29%; P=0.016).

Subject Self-Assessments
High levels of satisfaction were reported by subjects in both treatment groups. At 12 weeks, nearly all subjects reported improved overall appearance of skin (98%), reduced appearance of uneven skin tone/discoloration (96%), lightened darker patches (96%), improved evenness of skin (96%), and improved overall skin tone (98%). Only 20% of subjects reported bright skin tone at the start of study, which increased to 62% after 12 weeks.

Treatments were well-tolerated with only mild, transient AEs reported. Two AEs occurred in subjects in the combination treatment group. AEs included blemishes (n=3), redness (n=3), irritation (n=1), dryness (n=1), oiliness (n=1) and tingling (n=1). No subject discontinued use of the study products or dropped out of the study owing to an AE.