J. Cosmet. Sci., 71, 263–290 (September/October 2020) 263 Evaluating the Safety and Effi cacy of a Topical Formulation Containing Epidermal Growth Factor, Tranexamic Acid, Vitamin C, Arbutin, Niacinamide and Other Ingredients as Hydroquinone 4% Alternatives to Improve Hyperpigmentation: A Prospective, Randomized, Controlled Split Face Study BRANDON D. KALASHO, ARDALAN MINOKADEH, SANDY ZHANG-NUNES, RICHARD A. ZOUMALAN, NIMA L. SHEMIRANI, ANDREA R. WALDMAN, VADIM PLETZER, and CHRISTOPHER I. ZOUMALAN , Zoumalan Plastic Surgery, Beverly Hills, CA (B.D.K., R.A.Z., C.I.Z.) , Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA (A.M.), Department of Ophthalmology, Keck School of Medicine of USC, Los Angeles, CA (S.Z.-N.), Eos Rejuvenation, Beverly Hills, CA(N.L.S.), Albert Einstein College of Medicine, Montefi ore Medical Center, New York , NY (A.R.W.), KlinConsult, Wellington, New Zealand (V.P.) Accepted for publication April 13, 2020 . Synopsis Hyperpigmentation is a common concern of patients in aesthetic practice. There are various treatment options, but topical depigmenting agents such as hydroquinone (HQ) are usually a fi rst-line option. Given HQ’s side effects and potential controversy over its long-term use from prior animal studies, there is a consumer demand for non-HQ topical formulations that provide similar effi cacy, but with a reduced adverse reaction profi le to HQ. There is increasing evidence to support the use of selective growth factors, tranexamic acid, niacinamide, arbutin, and Vitamin C in improving hyperpigmentation. This study sought to determine whether a non-HQ topical formulation, composed of the aforementioned ingredients, could provide similar or improved effi cacy to topical HQ, but with a reduced adverse reaction profi le. This single-center, prospective, randomized, controlled split face study investigated the safety and effi cacy of a proprietary product SKNB19 compared with hydroquinone 4% (HQ4%) in treating hyperpigmentation. Eighteen adult subjects with facial pigmentation were randomly assigned to have one side of their face treated with SKNB19 twice a day (morning and night application) and the other treated with HQ4% applied nightly. Patients used a 5-point scale to self-assess their overall appearance, and a 4-point scale to assess redness, irritation, and tolerability to the skin-brightening creams. A Wilcoxon signed-rank test was used to test whether there was a statistical Address all correspondence to Christopher I. Zoumalan at research@zoumalanmd.com.
JOURNAL OF COSMETIC SCIENCE 264 difference between the two treatments. Three-dimensional imaging was performed before treatment was administered and again 1 month following treatment initiation using a Canfi eld Vectra 3D imaging system. Five independent reviewers comprising two dermatologists, two facial plastic surgeons, and one oculoplastic surgeon graded and performed a qualitative comparative assessment of each side of the face using the before and after images. A Wilcoxon signed-rank test was used to test whether there was a statistical difference in overall appearance between SKNB19- and HQ4%-treated sides. SKNB19-treated hyperpigmentation had a statistically signifi cant improvement in the overall appearance of hyperpigmentation and was shown to be 28.5% better than HQ4%-treated skin in the patient self-assessment and 27% better than HQ4%-treated skin in the independent reviewer assessment. On pair-wise comparison, the independent reviewer assessment also showed that 88.2% of the SKNB19-treated sides appeared equal or better than the HQ4%-treated sides. One patient dropped out of the study because of severe intolerance to HQ4%. No patients experienced intolerance to SKNB19, and all were able to continue its use without adverse effects. SKNB19-treated hyperpigmentation also had a statistically signifi cant reduction in irritation when compared with HQ4%- treated hyperpigmentation. Patients reported a reduction in redness when using SKNB19 as opposed to HQ4%, but these fi gures did not reach statistical signifi cance. This study supports that SKNB19, a recently developed non-HQ proprietary product, is safe and effective in improving hyperpigmentation. SKNB19 signifi cantly improved the appearance of hyperpigmentation when compared with HQ4% in both patient self-assessment and independent reviewer assessment. SKNB19 exhibited a lower adverse reaction profi le and was signifi cantly better tolerated than HQ4%. SKNB19 should be considered as a safe and effective non-HQ alternative for the management of hyperpigmentation. INTRODUCTION Hyperpigmentation is a common concern of patients in aesthetic practice, and it can re- sult from conditions such as melasma, postinfl ammatory hyperpigmentation (PIH), and solar lentigines (1). There are various treatment options available for hyperpigmentation, but the fi rst-line treatment includes topical depigmenting agents such as hydroquinone (HQ2–4%) but may also include the use of tretinoin, azelaic acid, superfi cial peeling agents, and/or lasers (1). Despite many possible treatment options, the results with these treatments are often temporary, especially in melasma, as the discoloration generally returns with continued exposure to the sun (2). Hydroquinone (HQ) is the most widely used and studied among possible treatment options. HQ’s ability to lighten hyperpigmentation stems from its competitive inhibition of the enzyme tyrosinase, which prevents the conversion of tyrosine to dihydroxyphenylalanine (DOPA), ultimately halting melanin synthesis (3). Although very effective and dosed at different strengths, HQ can cause an irritant dermatitis in some individuals, and chronic use can lead to exogenous ochronosis (4,5). Its use has been his- torically controversial because of some animal studies that have shown toxicity to DNA, renal, and liver cells (6–8). Because of such concerns, its use as a cosmetic additive has been banned in the European Union, and only available as a prescription (9). Given the aforementioned issues associated with HQ, there is a consumer demand for non-HQ topical formulations that provide similar effi cacy, but with a reduced adverse reaction profi le. Although various ingredients have been evaluated, tranexamic acid (TA) has been shown through various randomized, controlled trials to have similar effi cacy to HQ, but with a milder adverse reaction profi le (10–13). There is a growing interest in the use of growth factors in improving hyperpigmentation. Various growth factors such as epidermal growth factor (EGF), tumor necrosis factor al- pha, interleukins 1 and 6 (IL-1 and IL-6), Dickkopf 1 (DKK1), and transforming growth factor (TGF- β1) have been implicated in reducing melanocytic activity in previous stud- ies (14–17).
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