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Today’s nonprescription agents show promise, but more studies needed

Patients turn to their dermatologists for advice about cosmeceuticals. But with so little scientific evidence to back up cosmeceutical product claims, dermatologists often make recommendations based on what they believe — not hard data. That troubles many in the specialty.

Zoe Diana Draelos, MD, consulting professor at Duke University School of Medicine, said that good science covering cosmeceutical efficacy is hard to find.

“Something that has excellent research behind it is not going to be a cosmeceutical; it’s going to be a drug,” she said. Cosmeceutical studies typically look for improvements in appearance — not physiologic changes in the skin, she said. “So everything you say about your product has to do with appearance-related claims, such as improves the appearance of fine lines,’” she said.

Journal studies still sparse, but promising

“As an academic, a scientist, a doctor, and a woman, I totally empathize with this search for a great anti-aging product. But, at the same time, I want to protect my patients,” said Ellen Marmur, MD, chief of the division of dermatologic and cosmetic surgery at Mount Sinai Medical Center in New York City.

While a comprehensive scientific analysis of cosmeceuticals does not currently exist, dermatologists looking for evidence-based recommendations can cite two recent studies in the British Journal of Dermatology (BJD), according to Dr. Marmur.

Researchers published a study in BJD (2009;161 (2):419-426) investigating a commercially available anti-aging product, compared with a vehicle formulation. The product is a water in silicone emulsion with glycerine and other emollients and a complex of anti-aging’ ingredients comprising natural extracts and peptides: sodium ascorbyl phosphate, Panax ginseng, Morus alba, Lupinus alba, tocopherol, palmitoyl oligopeptide, palmitoyl tetrapeptide-7, Medicago sativa, and retinyl palmitate.[pagebreak]

The investigation revealed that 70 percent of the 60 sun-damaged subjects in the study using the product had significantly fewer wrinkles after 12 months of daily use compared to subjects using a placebo. The study, funded by the manufacturer, also concluded that the product promotes fibrillin-1 production, resulting in wrinkle reduction.

Dr. Marmur also found significance in a February 2010 comparison study published in BJD (2010; 162 (3): 647-54) comparing another commercially available product with 0.02 percent tretinoin. According to the article, after eight weeks of treatment, expert visual grading and objective computer imaging analyses suggested that more than half (58 percent) of the 196 women who participated in the study had better visible wrinkle reduction with the commercially available product compared to subjects in the tretinoin group. The product cited in the study also showed tolerability, according to Dr. Marmur.

“These are some of the first cosmeceutical studies,” Dr. Marmur said. “We went from having zero to a few.”

Physicians working toward more evidence-based knowledge

Dr. Marmur aims to change the evidence-based landscape for cosmeceuticals with a study she has underway analyzing the efficacy of six name-brand, over-the-counter cosmeceuticals. Dr. Marmur and colleagues are looking at pre-biopsies and post-biopsies after six months on these agents, compared to a control.

“We’re halfway through,” she said. “I’ll release the data sometime next year.”

While she cannot yet comment on the specific products, Dr. Marmur said that she and her colleagues are looking at biomarkers and whether or not there are shifts in skin age profiles from using these cosmeceuticals.

“We’re doing it because dermatologists have been asked to comment on new ingredients in cosmeceuticals, as if they’re medications,” Dr. Marmur said. She acknowledged that there is a lack of scientific rigor, and information, and that has led dermatologists to comment on opinions rather than data. “So, we’re hoping to add to the literature using the best possible science that we can,” she said.[pagebreak]

Looking beyond the obvious

While studies on specific products might be lacking, there is research on active ingredients. According to Jennifer Linder, MD, an assistant professor in the department of dermatology at University of California San Francisco, who practices in Scottsdale, Ariz., dermatologists can use well-documented knowledge on active ingredients to educate patients about cosmeceuticals. “I think, with the right ingredients, you can feel comfortable recommending cosmeceuticals and knowing that they really can make a difference in your patients’ skin,” Dr. Linder said.

The foundation of Dr. Linder’s recommended cosmeceutical regimen is retinol. She also suggests patients use topical antioxidants. For pigment control and collagen stimulation, Dr. Linder says she recommends that patients add topical vitamin C and sunscreen to their regimen.

“There are lots of great antioxidants out there. Those that have the best studies behind them are vitamin C. The version that is the most stable and effective is L-ascorbic acid in percentages of 15 to 20 percent,” she said. A quick search will also reveal studies offering scientific evidence supporting the potent antioxidant potential of products containing caffeine, vitamin E, resveratrol, green tea, genistein (found in soy), and glutathione, she said.

Dr. Linder steers her patients away from dimethylethanolamine, or DMAE, an ingredient used in some anti-wrinkle products that instantaneously plumps fine lines. “Unfortunately, a BJD study (2007; 156: 433-439) has shown that DMAE triggers the fibroblasts to swell, but then, the cells die,” Dr. Linder said. “I tell my patients that good skin care usually takes multiple weeks to months to work. Patients need to have more patience.”[pagebreak]

Tried and (still) true

Very often recommendations must come down to tried and true principles and not the latest exotic ingredients. Usually, according to Dr. Draelos, the most important agent in a cosmeceutical is its moisturizer.

“The moisturizing vehicle that they put in the caviar extract, in the mushroom protein or peptide is the most important, not the added ingredient,” she said. Ingredients such as dimethicone and glycerine are what make moisturizers effective, according to Dr. Draelos. “If moisturizers have a lot of water, they’re not so good,” she said.

Dr. Draelos also reported that she is among many dermatologists who still rely on the gold-standard prescription tretinoin when patients request a topical anti-aging product. For those who cannot tolerate the prescription product, she’ll recommend retinol in a moisturizing vehicle.

The future of cosmeceuticals

While Dr. Draelos says advances in cosmeceuticals have been flat in the last year, there is promising research. Among the areas that are offering glimmers of hope: new delivery systems and repackaging old ingredients to produce new effects.

“For example, people are now taking pigment and grinding that into small particles to create the new makeups that provide better camouflaging.”

But the truth is that, for the moment, dermatologists don’t yet fully understand why cosmeceuticals might or might not work, according to Dr. Marmur. “It would be amazing to find out. It’s probably not just one active ingredient that is going to be the answer. It’ll probably be a chain of events,” she said.

In the meantime, dermatologists should adhere to core principles when making nonprescription recommendations, according to Dr. Marmur. Chief among these principles will always be to protect the skin using sun protection and moisturizer, she said.