One area of rising interest in both cosmetic and medical dermatology is management of pigmentation. In the treatment of melasma and photoaging, hydroquinone has figured prominently as a monotherapy and in treatments known for strong efficacy, such as Tri-Luma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, Galderma). However, concerns regarding the safety of hydroquinone have raised questions about the ingredient and the long-term role it should play in skin brightening and the treatment of pigmentation disorders.

Addressing concerns about skin brightening products containing hydroquinone, Neocutis recently unveiled Perle Skin Brightening Cream, the newest skin brightening product that does not contain hydroquinone. Although large studies are desirable to confirm the efficacy of Perle, one preliminary study presented in October 2010 at the 19th EADV Congress in Gothenburg, Sweden, found the product effective in improving signs of facial skin discolorations, including skin tone and appearance of age spots. Ahead, co-investigator Michael H. Gold, MD, Clinical Assistant Professor of Dermatology at Vanderbilt University School of Medicine and Medical Director of Gold Skin Care Center in Nashville, TN, discusses his findings as well as the future of hydroquinone-free skin brightening products.

Can you discuss the study and your findings within the context of current knowledge and research on melasma?

The prescient issue in melasma treatment and issues of skin pigmentation concerns the uncertainty of hydroquinone, according to Dr. Gold. “Given the safety concerns and limitations of hydroquinone, it's hard to predict what its future holds,” he observes. The only prescription strength hydroquinone- containing brand product on the market is Tri-Luma, which has shown to be effective, but can only be used for certain periods of time and under the right circumstances. While hydroquinone is generally effective and safe if used properly, physicians and researchers are looking for new approaches and ways to address issues of pigment, Dr. Gold observes. “Physicians often employ a variety of therapies on photoaging and melasma, from peels, to lasers, to topical therapies, all of which have distinct advantages and disadvantages,” he states.

Perle is formulated with Melaplex® the same brightening complex contained in Neocutis' previous Hydroquinone product, Blanche, according to Dr. Gold, however Perle is hydroquinone-free. The four actives comprising Melaplex are L-leucine, sodium glycerophosphate, phenylethyl resorcinol, and undecylenoyl phenylalanine. “The study was designed to test the efficacy of this cream to determine whether it offers comparable equivalence to hydroquinone without the hydroquinone,” Dr. Gold notes. The study evaluated 19 individuals using Perle twice a day along with daily sunscreen application and found a 43 percent improvement in skin tone after 12 weeks. Skin brightening improved by 27 percent.

What separates Perle from other agents and creams used to treat melasma?
Dr. Gold observes that while the results of treatment with Perle are not as significant as those for fluocinolone acetonide 0.01%/hydroquinone 4%/tretinoin 0.05% in terms of efficacy, the level of improvement seen in many patients is particularly noteworthy given the absence of hydroquinone. Dr Gold also notes that Perle does not contain kojic acid, another ingredient associated with safety issues. “The advantage of this product is that it is comprised of non-irritating actives, relieving any concerns for safety, while also delivering improvement of up to 50 percent of melasma and photoaging,” Dr. Gold says.

While the efficacy will not match hydroquinonebased products, Dr. Gold notes that physicians can use this cream in a number of ways. “Perle may be especially useful as a maintenance therapy after an initial 12-week treatment with hydroquinone, or it could be used in combination,” Dr. Gold says. “Without the question marks associated with hydroquinone, physicians can be creative with how to employ this skin brightening cream in a treatment regimen,” he adds.

How do you foresee the future of skin brightening unfolding with the continued development of agents not containing hydroquinone?
While larger studies are needed to confirm the efficacy of this particular product, Dr. Gold finds these results encouraging as the demand for improved approaches to photoaging and postinflammatory hyperpigmentation increases. “Pigmentation may likely become one of the major issues that dermatologists tackle in coming years, and that will be reflected in the rapidly growing skin brightening market,” predicts Dr. Gold. Perle is the first hydroquinone-free skin brightening cream that addresses the many steps involved in the formation of pigment beyond just tyrosinase, but Dr. Gold believes that it may be the first of many products offering a safe, effective alternative to hydroquinone in the treatment of melasma and hyperpigmentation.