Comparing the Efficacy and Tolerability of Moderate to Severe Hyperpigmentation and Skin Unevenness

January 2024 | Volume 23 | Issue 1 | 1260 | Copyright © January 2024


Published online December 21, 2023

Valerie D. Callender MDa,b, Diane Orlinsky MDc,d, Eva Simmons -O'Brien MDc,d, Nina C. Nwade BAe, Tanya Rhodes PhDf, Angel S. Byrd MD PhDb

aCallender Dermatology & Cosmetic Center, Glenn Dale, MD
bDepartment of Dermatology, Howard University College of Medicine, Washington, DC
cSimmons-O’Brien & Orlinsky, LLC, Towson, MD
dDepartment of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD
eHoward University College of Medicine, Washington, DC
fSente® Laboratories, Carlsbad, CA 

Abstract
Dyschromia is the result of irregular facial pigmentation. These cutaneous manifestations can have a significant impact on the quality of life of those affected, especially among females and skin of color. In this randomized, double-blinded, two-cell, single-center, 16-week clinical study, all subjects had moderate to severe (scores 4-9 on the modified Griffiths Scale) hyperpigmentation and skin unevenness of the face such that approximately 20% of subjects had post-inflammatory hyperpigmentation (PIH), 40% had overall mottled hyperpigmentation, and 40% had superficial melasma (Superficial Melasma was determined by Wood's Lamp Assessment). Study participants received either Product A (proprietary new formulation - Cysteamine HSA) or Product B (current marketed product - Cyspera®) and used the test product either in the morning or at night, beginning with every other day application, and then advanced to every day, or as tolerated. The results revealed that both Product A (Cysteamine HSA) and Product B (Cyspera®) had statistically significant improvement in facial hyperpigmentation and skin unevenness, however, Product A (Cysteamine HSA) had better tolerability results for scaling, peeling, burning, stinging, erythema, and dryness, indicating that Product A (Cysteamine HSA) outperformed Product B (Cyspera®).

J Drugs Dermatol. 2024;23(1):1260-1265.     doi:10.36849/JDD.7584

INTRODUCTION

Dyschromia conditions such as melasma, hypopigmentation, and post-inflammatory hyperpigmentation can prove to be distressing to patients, particularly those with Fitzpatrick skin types II-VI. Dyschromia is known to be the fifth most common diagnosis in African Americans, and the tenth most common diagnosis in Hispanic patients.1

Melasma is a condition commonly seen in women of Fitzpatrick skin types III-VI and negatively impacts patients physically, emotionally, socially, and financially. It presents as tan and brown irregular patches on the face and neck. Risk factors include UV radiation exposure, pregnancy, oral contraceptives, and hormonal therapy, amongst others. Melasma is a clinical diagnosis, with the help of a Wood’s lamp2 to examine disease extent, or a dermatoscope to differentiate between epidermal melasma and dermal melasma.3  

Treatment options include topical hypopigmenting agents (hydroquinone, tretinoin, kojic acid, and azelaic acid) such as  Cyspera® and Kligman's formula, chemical peels, laser therapy, and dermabrasion.3 It is imperative, however, to be intentional about the treatment options for darker skin types, including, but not limited to, the family history of dyschromia, as medium to deep peels and some laser treatments may lead to post-inflammatory hyperpigmentation and scarring.3 Therefore, there is a greater push towards safe, curative treatment options for Fitzpatrick skin types IV-VI,4 which contains larger and more numerous melanosomes that are more dispersed amongst the epidermis. These melanin containing melanosomes are produced by melanocytes, which respond easily to irritation and inflammation, resulting in increased susceptibility to hyperpigmentation.5

Therefore, we conducted a study of a novel treatment, known as Cysteamine HSA (Product A) containing the active ingredients
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