Journal of Clinical and Aesthetic Dermatology - Science of Skin Summit 2025

135—A single center, open-label clinical trial evaluated the tolerability and efficacy of an advanced skin brightener in subjects with mild-to-severe dyschromia/hyperpigmentation

2025-10-29 09:01:27

Presenters: Draelos ZDD,1 Nelson DB2

Affiliations: 1Dermatology Consulting Service, PLLC, High Point, NC; 2skinbetter science, a Dermatological Beauty brand of L’Oréal USA, Inc., Phoenix, AZ

Background: Hyperpigmentation is multifactorial and thus is a challenging condition to treat. A new multi-modal skin tone correcting serum formulated using b.r.y.t.e.r. biotechnology targets five primary pathways of melanin synthesis to mitigate persistent pigmentation, resurface and exfoliate skin, and reduce unwanted brown, red and yellow discoloration.

Objectives: To evaluate the effectiveness and tolerability of a new skin tone correcting serum (EV-I) used alone and in combination with a double-conjugated retinoid/alpha hydroxy acid cream (AHARet) in subjects with mild-to-severe dyschromia/hyperpigmentation.

Methods: A single-center, open-label 12-week trial enrolled healthy females, 30-65 years, with mild-to-severe dyschromia/ hyperpigmentation according to a 6-point grading scale (0=None to 5=Very Severe). All subjects applied EV-I twice-daily for 12 weeks with a subset of subjects also applying AHARet nightly for 12 weeks. Investigator assessment of pigmentation was graded according to the Melasma Area and Severity Index (MASI) Scale at baseline, 2, 4, 8, and 12 weeks. Investigator evaluation of skin dullness and texture/roughness was assessed using a 6-point grading scale (0=None to 5=Very Severe). Erythema and dryness/flaking was assessed using a 4-point grading scale (0=None to 3=Severe). Subjects completed self-assessment questionnaires at 2, 4, 8, and 12 weeks. Adverse Events (AEs) were collected throughout the study.

Results: Subjects enrolled in the EV-I (N=40) and EV-I/AHARet (N=25) groups were similar with a mean age of 53 years, predominantly Caucasian and non-Hispanic, and the majority of subjects presenting with moderate-to-severe dyschromia/hyperpigmentation. Significant mean percent improvements from baseline were demonstrated in both groups based on the MASI scale at 12 Weeks (EV-I, 42% [p<.0001] with additional improvements noted with combination use (EV-I/AHARet, 47% [p<.0001]). Significant mean improvements from baseline were demonstrated in both groups in skin texture (EV-I, 46%; EV-I/AHARet, 59% ) and dullness (EV-I, 47% ; EV-I/AHARet, 59% [all, p<.0001]) at 12 Weeks. There were no increases in dryness/flaking or erythema observed in either group. Subject satisfaction was high in both groups throughout the study, with >80% of subjects reporting that their skin tone was more even-looking, brighter, less discolored and less dull-looking at Week 4. At 12 weeks, 90% of subjects in the EV-I group reported that the brown/dark spots or patches on their skin were lighter in appearance.

Conclusion: A multi-modal skin tone correcting serum developed to target the five primary pathways of melanin synthesis demonstrated significant improvements in MASI scores, and in skin texture and dullness. Additional and significant improvements were demonstrated in subjects using both the skin tone correcting serum and a double-conjugated/alpha hydroxy acid cream. No increases in dryness/flaking or erythema were observed throughout the study.

Disclosures: Dr. Draelos was a study investigator, and Ms. Nelson is an employee of skinbetter science.

Funding: This study was sponsored by skinbetter science, a Dermatological Beauty brand of L’Oréal USA, Inc.

©Matrix Medical Communications. View All Articles.

135—A single center, open-label clinical trial evaluated the tolerability and efficacy of an advanced skin brightener in subjects with mild-to-severe dyschromia/hyperpigmentation
https://jcad.mydigitalpublication.com/articles/135-a-single-center-open-label-clinical-trial-evaluated-the-tolerability-and-efficacy-of-an-advanced-skin-brightener-in-subjects-with-mild-to-severe-dyschromia-hyperpigmentation

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