Double Blind, Placebo Controlled Evaluation of a Novel Skin Lightening Agent

January 2018 | Volume 17 | Issue 1 | Original Article | 113 | Copyright © 2018

James M. Spencer MD MS,a Julianna Accioly MA,a Neal Kitchen PhDb

aSpencer Dermatology & Skin Surgery Center, St Petersburg, FL bHydroPeptide, Issaquah, WA

Abstract

Melasma remains a troubling problem for physicans and patients alike. It is a chronic irregular, symmetric hyperpigmentation seen most often in women. In this study, a unique combination of ingredients with non-irritating properties was tested for treatment of melasma. In a double blind, placebo controlled, split face trial, 17 patients with melasma were treated on one half of the face, left or right, while the other received placebo control. All patients used sunscreen on both sides. Measurement with a colorimeter (Mexameter) was taken at baseline and after 8 weeks of daily use. The active side showed an objective decrease in hyperpigmentation of 14.60% while the control side showed a decrease of 9.82%. We conclude the product provides a non-irritating effective therapy for melasma.

J Drugs Dermatol. 2018;17(1):113-115.

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INTRODUCTION

Melasma is a chronic, often refractory disorder characterized by irregular patches of hyperpigmentation in a symmetric distribution on the sun exposed area of the face. It is most often seen in women, skin types III-V, but it can be seen in other skin types and in men as well. The pathogenesis is not well understood, but it is associated with UV light stimulating hyperactive melanocytes as well as female sex hormones. Treatment is often unsatisfactory due to frequent recurrence. The mainstay of therapy has been skin lightening creams containing hydroquinone, which act by blocking tyrosinase in the production of melanin. The most effective formulation seems to be a triple combination of hydroquinone, tretinoin, and a steroid to enhance tolerability. Other topicals include kojic acid, azelic acid, ascorbic acid, retinoids, phloretin, ferulic acid, lignin peroxidase.1 These products are typically utilized in a program of sunscreen and sun protection to minimize UV exposure. Further treatments include chemical peels with glycolic acid, salicylic acid, and trichloroacetic acid. Finally, laser and light devices can be used with caution to target pigment, but post-inflammatory hyperpigmentation is common in melasma patients.1Hydroquinone is irritating and, although highly unlikely, the FDA has raised the specter of carcinogenesis with this product, and therefore a search for an alternative has been pursued. This has led to a host of botanical products being introduced to the market containing ingredients such as Silymarin, arbutin, resveratrol, aloe vera, pycnogenol, bosweillia, aloesin, nicinamide, and extracts of coffeeberry, soy, green tea, orchids, grape seed, marine algae, and licorice to name a few.2LumaPro-C is a unique blend of ingredients meant to address the need for safe and effective skin lightening for melasma as well as general skin brightening. It is thought to work by three mechanisms. First, it contains a resurfacing peptide with stabilized vitamin C to promote exfoliation. Second, it contains botanicals to reduce melanogenisis and inflammation including resveratrol, daisy and pine extracts, and ginger extract. Finally, to further impede melanogenisis an encapsulated plankton extract and a probiotic regulator are included. It was our intention to test this product’s ability to reduce the hyperpigmentation of melasma.

METHODS

Seventeen patients, all women with facial melasma, were recruited for this study. At baseline, a mexameter, which is a type of colorimeter that objectively measures brown and red, was used to take readings from the worst involved areas on both sides of the face. Patients were instructed to use sunscreen on both sides of the face twice daily and given samples to do so. Patients were then randomized to receive active cream or placebo, each to be applied to one side of the face left or right BID for 8 weeks. Patients and the evaluating physician were blinded as to which side was active and which was control. Patients were photographed and mexameter readings taken at baseline, at 2 weeks, 4 weeks, and 8 weeks. At the end of the study, patients were asked to evaluate if they could perceive one side to look better than the other, and a physician’s global assessment asked the same question.

RESULTS

Sixteen of the seventeen patients enrolled completed the 8-week study. At the end of 8 weeks, the control side showed an average decreased mexameter reading of 9.82%, while the active side showed an average decrease of 14.60% (Table 1). On the patient’s subjective analysis, 13 of 16 patients reported they could

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