People across the country are asking, “What happened to Tri-Luma?” Without any formal announcement from its maker, Galderma, supplies of the product just started to dry up. It’s no longer at the pharmacies, and the few physicians’ offices that stocked and dispensed it directly seem to be out as well. The reason why is apparently something that Galderma has not been quick to comment on. One of the very few references to it anywhere comes from a dermatologist who was quoted in late October 2010 on the ELLE magazine website as saying, “Tri-Luma is on back-order right now, which is very rare for a prescription product.”
However, we did find our first clue for this mystery in a posting on the FDA’s website for recall advisories confirming that Galderma actually issued a full recall in late August, 2010 of all Tri-Luma product manufactured by its sub-contract manufacturer, Hill Dermaceuticals. The reason given for the recall was that Hill notified Galderma of “a subpotent active ingredient”. This reason seems to indicate that they discovered one of the active ingredients in Tri-Luma (the main actives are Hydroquinone, Tretinoin, and the corticosteroid fluocinolone acetonide), was not meeting labeling standards of concentration and/or potency.
With many patients around the world watching for its return, there is no word as to when Tri-Luma may be re-introduced to the market. A much bigger piece of the puzzle was revealed in late September 2011, more than a year after the initial recall. That is when, according to the FDA website, “The U.S. Food and Drug Administration announced today that the District Court for the Middle District of Florida entered a consent decree that prohibits Hill Dermaceuticals, Inc. and Hill Labs, Inc…. from introducing adulterated drugs into interstate commerce.” In other words, Hill Dermaceuticals and it’s principals, who are listed as holders of the patents that, at least in part, cover the Tri-Luma product, can no longer make the drug, unless/until corrective actions are taken to the satisfaction of the FDA.
“Because this company continued to violate current good manufacturing practice regulations and falsify information on submissions to FDA, the agency took this action in an effort to protect consumers,” said Dara Corrigan, the FDA’s Associate Commissioner for Regulatory Affairs. “The FDA continues to be committed to protecting consumers from potentially unsafe products that may be offered on the market.”
This does not mean that Tri-Luma won’t ever return to the market. But when Tri-Luma might return to the market is still largely in question, to the disappointment of many dermatologists and patients that found the product a useful tool for treating melasma and other related pigmentary issues. Even when it was available, Tri-Luma’s use is generally limited to a few weeks at a time. In fact, the FDA issued a warning on Tri-Luma last year on this subject, requiring clear instructions be included with the product that, “Tri-Luma is indicated for the short term treatment”, and NOT for ongoing maintenance of melasma. And yet, patients who don’t use anything after their initial Tri-Luma treatment often suffer a “rebounding” effect where their melasma comes back – potentially worse than it was before.
So what can patients do for hyperpigmentation now? If it is true that every challenge brings with it new opportunities, then this may be an opportunity for those Tri-Luma patients to try something else to address their skin tone concerns. Since entering the market in 2009, Lumixyl has provided the answer, coming from your doctor but without the need of a prescription and a trip to the pharmacy.
While not a drug, the Lumixyl Topical Brightening System is the obvious alternative for those looking for brighter, clearer, healthier skin and a more even tone. In fact, one of its strengths is that it does not rely on topical steroids, hydroquinone, or other harsh and irritating drugs to promote healthy skin tone. Instead, it relies on decapeptide-12, a non-toxic, non-irritating peptide proven to reduce the appearance of hyperpigmentation for a more even complexion. The system also incorporates powerful antioxidants and clinical grade glycolic acid to stimulate cell turnover, aid collagen and fibroblast proliferation, and prevent photodamage from occurring, resulting in improved skin texture and quality.
Four Steps to a Brighter You
The Lumixyl Topical Brightening System is an entirely new approach to naturally brighter, more vibrant skin, representing a new standard in physician-grade skincare.
An innovation in skin brightening technology, the four products that comprise the Lumixyl Topical Brightening System work synergistically to target existing hyperpigmentation and to prevent its recurrence.
Through the use of botanical antioxidants, the Active-Prep Cleanser contributes to lower levels of oxidative stress in the skin for reduced melanin stimulation, while the Lumixyl peptide – Decapeptide-12 – in the Lumixyl Topical Brightening Creme, works to help regulate overproduction of melanin by inhibiting the tyrosinase enzyme used to create melanin by the melanocytes in your skin.
The GlycoPeel 20 Rapid Exfoliating Lotion uses a clinical grade glycolic acid to help remove the dead layers of the stratum corneum, where hyperpigmented cells can concentrate. This level of exfoliation also helps healthy skin function by stimulating the skin’s natural turnover process.
The MoistureLock Sunscreen SPF30 is a breakthrough in elegant sun protection. This sunscreen helps to prevent UV-induced melanin overproduction, and protects the skin from photo-damage that leads to prematurely aged skin.
A clinical study published in the Journal of Drugs in Dermatology, which was conducted with 5 patients who had used Tri-Luma previously without achieving successful clearance of their melasma (skin discoloration), showed that in every case they achieved significant clearance of the melasma after 12 weeks of daily application of the Lumixyl peptide.
If you are looking for a solution for skin discoloration and were frustrated to find that Tri-Luma is not available, Lumixyl may actually be the real solution you are looking for.
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