A Novel Topical Agent for the Management of Hyperpigmentation, Including Melasma and Age Spots

January 2026 | Volume 25 | Issue 1 | 75 | Copyright © January 2026


Published online December 31, 2025

Xinge Diana Zhang PhDa, Claudia Teng a, Xuefei Bai MBAa, Leslie Clark-Loeser MD FAADb, Marianna Blyumin-Karasik MD FAADb, Joyce M.C. Teng PhD FAADc, Michael Gold MD FAADd

aB.A.I. Biosciences, Inc. Cambridge, MA
bPrecision Skin Institute, Davie, FL
cDepartment of Dermatology, Stanford University School of Medicine, Stanford, CA
dGold Skin Care Center, Nashville, TN

Abstract
Background/Objectives: Melasma and age spots are among the most persistent and difficult-to-treat forms of hyperpigmentation. While traditional therapies offer some clinical efficacy, they often carry risks of irritation and rebound pigmentation. This study aims to evaluate the therapeutic potential and user tolerability of nanodiamond-zinc oxide (ND-ZnO)-containing skin preparations in improving hyperpigmentation conditions through 11 individual case series and 32 user-reported outcomes.
Methods: We analyzed 11 real-world case studies involving daily usage of ND-ZnO-containing cream and serum over a period of 4 to 12 weeks. Participants varied in age, ethnicity, and Fitzpatrick skin type (FST). Cases were selected based on adherence, diversity of presentation, and completeness of photographic and evaluative documentation.
Results: All 11 case participants demonstrated visible improvements in hyperpigmentation, with varying degrees of reduction in melasma and age spots. Among 32 questionnaire respondents, 90.63% reported a visible reduction in hyperpigmentation, 96.9% noted brighter and more even skin tone, and 93.75% observed improved radiance. All participants tolerated the treatment well, with 100% non-irritation confirmed by two separate Human Repeat Insult Patch Test (HRIPT) studies.
Conclusions: ND-ZnO-containing skin preparations offer a well-tolerated and effective alternative to conventional treatments for melasma and age spots. Their multi-action approach, which combines UV protection, reactive oxygen species (ROS) scavenging, and enhanced delivery of actives, supports both prevention and repair of pigmentation. These findings suggest ND-ZnO formulations may serve as a safer and more compliant option for long-term hyperpigmentation management.

 

INTRODUCTION

Melasma is a chronic hyperpigmentation disorder that affects approximately 1% of the general population and up to 1 in 2.5 people in high-risk groups and poses a major therapeutic challenge for dermatologists. This disorder appears as dark brown or gray-brown patches symmetrically on the face, especially on the cheeks, forehead, nose, and upper lip. Melasma has a multifactorial etiology including a combination of genetic predisposition, hormonal factors, ultraviolet radiation, skin phototype, and different environmental factors.1-3

Genetic predisposition is a major cause of melasma: 48% to 64% of affected individuals reported a family history. Melasma is more common among women due to hormonal factors. Previous studies have also shown that taking oral contraceptives increases the chance of melasma due to drastic hormonal shifts.2 Pregnancy has also been proven to be a major cause. Between 15% and 50% of pregnant women are reported to be affected by melasma. Beyond intrinsic factors, sun exposure is a major external trigger. Ultraviolet (UV) radiation and even visible light at 415 nm from sun exposure have been identified as major triggers inducing reactive oxygen species and melanin production.

Age spots, also known as solar lentigines or liver spots, are another common type of hyperpigmentation. These flat, tan, brown, or black growths usually appear on parts of the skin that are most exposed to the sun (face, hands, shoulders, and arms). Age spots are the result of cumulative sun exposure over time, leading to the production of excess melanin in localized patches. Age spots are different from melasma in their cause, appearance, distribution, demographic prevalence,