Knowing how to separate fact from fiction when it comes to products claiming to rejuvenate the skin is essential to providing your patients with the safest and most effective products. Not so long ago, there really wasn’t much out there that could truly make a 50 year old look 45. Cosmetic companies dominated the field and sold what they called “hope in a bottle,” that is, they apparently were hoping consumers would believe their advertising and purchase what were essentially emollients designed to help hydrate the skin and thus eliminate the appearance of some fine lines and dryness. Fortunately, times have changed. Thanks to medical research in the aesthetic skin care field, much more is now known about how the skin ages, and ingredients have been developed that slow down, and in some cases, partially reverse, some of the key signs of photoaging. This prompts the question, How can skin care professionals evaluate these ingredients and choose appropriate products for their patients? Quantity of Peer-Reviewed Evidence One of the best ways to evaluate the vast array of drugs approved to treat a given condition is by ranking ingredients according to both the quantity and quality of peer-reviewed evidence published in the medical literature, a process that involves scrutiny of experimental materials, methodology and data to insure reproducibility. When such standards are applied to products that are promoted to skin care professionals, a sense of organization emerges that can serve as a kind of screening tool. The chart shown in Figure 1 is a ranking of various topical active ingredients based on a quantitative review of available Medline data. Proven Options Without question, retinoids represent the “gold standard” for the treatment of photoaging based on the sheer quantity of peer-reviewed evidence. Note that it is also the only category that includes products specifically approved by the FDA for the treatment of this indication. Following retinoids are hydroxyacids, which have established themselves as safe and effective for managing certain signs of superficial photoaging, but with less profound biological effects than retinoids. Topical anti-oxidants are next on the list but they are supported by far less peer-reviewed evidence than retinoids and hydroxyacids. Unsubstantiated Claims Beyond topical anti-oxidants are additional popular skin care ingredients for which little objective, peer-reviewed evidence is available. Note that some products in these categories are heavily promoted as miraculous skin rejuvenating agents and sell for high prices, but in reality, there exists little proof that they are safe and effective. While claims like “20% reduction in fine lines” sound impressive, such benefits can usually be achieved through routine use of a simple moisturizing sunscreen. Bottom Line Given that for around $60 your patients can purchase a tube of generic tretinoin cream, which is proven safe and effective and is even approved by the FDA for treating photoaging, skin care professionals should make sure to get some hard evidence showing that that new highly touted $120 cosmeceutical is twice as good as that generic tretinoin cream. Dose-Response and Stability Evidence Dose-Response Studies — Effective Concentration Once it has been determined where a product ranks in terms of quality of peer-reviewed evidence of the safety, efficacy and cost-effectiveness of its active constituents, the question becomes, Does the product contain enough of this ingredient to have a biological effect? This relationship between concentration and effectiveness is determined by dose-response studies. Consequently, precise information on concentration is critical to determining if a product is worth using. As far as retinol is concerned, it’s usually used in concentrations from about 0.1% to 1%, with the higher strengths being more effective but potentially more irritating. With this information, it’s clear that a product containing 0.001% retinol is not going to do much. Stability Evidence — Possible Loss of Effectiveness As if skin care decision-making isn’t complicated enough, consider that many of the actives in cosmeceutical products, such as retinol, vitamin C and kojic acid, are sensitive to oxygen, light and heat and have poor stability in aqueous media. While such ingredients may start out at a sufficient concentration to have a meaningful biological effect, they can degrade fairly quickly to render the product sub-potent before or during use. Good examples are solutions of vitamin C; such solutions must be crystal clear and colorless. When these solutions turn yellow, brown or black, these color changes indicate the presence of oxidized ascorbic acid. So when a manufacturer claims such color changes don’t represent a problem, request a study proving that these oxides have the same efficacy as pure, unoxidized vitamin C. Since the science suggests that ascorbic acid oxides no longer react with free radicals and thus aren’t very good anti-oxidants, it is unlikely you will receive one. How to Ascertain Product Quality — Where HPLC Comes In A great way skin care professionals can assure themselves of the potency of cosmeceutical actives is to request from the manufacturer an HPLC (High Performance Liquid Chromatography) stability study of the product in question. HPLC is based on the chemical principle that molecules can be separated from each other based on differences in their affinities for a common material. With HPLC, that material is usually in the form of specially coated beads packed into a chromatography column. By comparing with a known standard the characteristics of samples before and after entering the column, such as how they absorb a beam of ultraviolet light, it’s possible to determine the presence and concentration of various actives quickly, economically and with a very high degree of precision. For this reason, HPLC is the most commonly used analytical method in the pharmaceutical industry, and all reputable skin care product manufacturers have HPLC instrumentation in their labs. It is also important to look at the stability of a product when stored at warm temperatures commonly experienced when it’s shipped during summer months or after its container is opened and the product is partly used. (In general, the more “head space” of air, the more oxygen exposure and potential oxidation.) All of these details are relevant and can make a difference between effective and ineffective treatments. Conclusion In conclusion, skin care products can be evaluated by first identifying their active components and their concentration, confirming stability and considering the quality of peer-reviewed evidence supporting their safety, efficacy and cost-effectiveness. Taking the time to learn this information from manufacturers will help skin care professionals provide their patients with the best possible treatments. John E. Kulesza is founder and president of Young Pharmaceuticals, Inc., a 32-year old firm based in Hartford, CT. that develops and markets proprietary dermatology products to dispensing physicians. Mr. Kulesza, an industrial chemist by training, holds several U.S. patents on dermatological technologies. Disclosure: John E. Kulesza is founder and president of Young Pharmaceuticals, Inc.
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Evidence-Based Skin Care
Knowing how to separate fact from fiction when it comes to products claiming to rejuvenate the skin is essential to providing your patients with the safest and most effective products. Not so long ago, there really wasn’t much out there that could truly make a 50 year old look 45. Cosmetic companies dominated the field and sold what they called “hope in a bottle,” that is, they apparently were hoping consumers would believe their advertising and purchase what were essentially emollients designed to help hydrate the skin and thus eliminate the appearance of some fine lines and dryness. Fortunately, times have changed. Thanks to medical research in the aesthetic skin care field, much more is now known about how the skin ages, and ingredients have been developed that slow down, and in some cases, partially reverse, some of the key signs of photoaging. This prompts the question, How can skin care professionals evaluate these ingredients and choose appropriate products for their patients? Quantity of Peer-Reviewed Evidence One of the best ways to evaluate the vast array of drugs approved to treat a given condition is by ranking ingredients according to both the quantity and quality of peer-reviewed evidence published in the medical literature, a process that involves scrutiny of experimental materials, methodology and data to insure reproducibility. When such standards are applied to products that are promoted to skin care professionals, a sense of organization emerges that can serve as a kind of screening tool. The chart shown in Figure 1 is a ranking of various topical active ingredients based on a quantitative review of available Medline data. Proven Options Without question, retinoids represent the “gold standard” for the treatment of photoaging based on the sheer quantity of peer-reviewed evidence. Note that it is also the only category that includes products specifically approved by the FDA for the treatment of this indication. Following retinoids are hydroxyacids, which have established themselves as safe and effective for managing certain signs of superficial photoaging, but with less profound biological effects than retinoids. Topical anti-oxidants are next on the list but they are supported by far less peer-reviewed evidence than retinoids and hydroxyacids. Unsubstantiated Claims Beyond topical anti-oxidants are additional popular skin care ingredients for which little objective, peer-reviewed evidence is available. Note that some products in these categories are heavily promoted as miraculous skin rejuvenating agents and sell for high prices, but in reality, there exists little proof that they are safe and effective. While claims like “20% reduction in fine lines” sound impressive, such benefits can usually be achieved through routine use of a simple moisturizing sunscreen. Bottom Line Given that for around $60 your patients can purchase a tube of generic tretinoin cream, which is proven safe and effective and is even approved by the FDA for treating photoaging, skin care professionals should make sure to get some hard evidence showing that that new highly touted $120 cosmeceutical is twice as good as that generic tretinoin cream. Dose-Response and Stability Evidence Dose-Response Studies — Effective Concentration Once it has been determined where a product ranks in terms of quality of peer-reviewed evidence of the safety, efficacy and cost-effectiveness of its active constituents, the question becomes, Does the product contain enough of this ingredient to have a biological effect? This relationship between concentration and effectiveness is determined by dose-response studies. Consequently, precise information on concentration is critical to determining if a product is worth using. As far as retinol is concerned, it’s usually used in concentrations from about 0.1% to 1%, with the higher strengths being more effective but potentially more irritating. With this information, it’s clear that a product containing 0.001% retinol is not going to do much. Stability Evidence — Possible Loss of Effectiveness As if skin care decision-making isn’t complicated enough, consider that many of the actives in cosmeceutical products, such as retinol, vitamin C and kojic acid, are sensitive to oxygen, light and heat and have poor stability in aqueous media. While such ingredients may start out at a sufficient concentration to have a meaningful biological effect, they can degrade fairly quickly to render the product sub-potent before or during use. Good examples are solutions of vitamin C; such solutions must be crystal clear and colorless. When these solutions turn yellow, brown or black, these color changes indicate the presence of oxidized ascorbic acid. So when a manufacturer claims such color changes don’t represent a problem, request a study proving that these oxides have the same efficacy as pure, unoxidized vitamin C. Since the science suggests that ascorbic acid oxides no longer react with free radicals and thus aren’t very good anti-oxidants, it is unlikely you will receive one. How to Ascertain Product Quality — Where HPLC Comes In A great way skin care professionals can assure themselves of the potency of cosmeceutical actives is to request from the manufacturer an HPLC (High Performance Liquid Chromatography) stability study of the product in question. HPLC is based on the chemical principle that molecules can be separated from each other based on differences in their affinities for a common material. With HPLC, that material is usually in the form of specially coated beads packed into a chromatography column. By comparing with a known standard the characteristics of samples before and after entering the column, such as how they absorb a beam of ultraviolet light, it’s possible to determine the presence and concentration of various actives quickly, economically and with a very high degree of precision. For this reason, HPLC is the most commonly used analytical method in the pharmaceutical industry, and all reputable skin care product manufacturers have HPLC instrumentation in their labs. It is also important to look at the stability of a product when stored at warm temperatures commonly experienced when it’s shipped during summer months or after its container is opened and the product is partly used. (In general, the more “head space” of air, the more oxygen exposure and potential oxidation.) All of these details are relevant and can make a difference between effective and ineffective treatments. Conclusion In conclusion, skin care products can be evaluated by first identifying their active components and their concentration, confirming stability and considering the quality of peer-reviewed evidence supporting their safety, efficacy and cost-effectiveness. Taking the time to learn this information from manufacturers will help skin care professionals provide their patients with the best possible treatments. John E. Kulesza is founder and president of Young Pharmaceuticals, Inc., a 32-year old firm based in Hartford, CT. that develops and markets proprietary dermatology products to dispensing physicians. Mr. Kulesza, an industrial chemist by training, holds several U.S. patents on dermatological technologies. Disclosure: John E. Kulesza is founder and president of Young Pharmaceuticals, Inc.
Knowing how to separate fact from fiction when it comes to products claiming to rejuvenate the skin is essential to providing your patients with the safest and most effective products. Not so long ago, there really wasn’t much out there that could truly make a 50 year old look 45. Cosmetic companies dominated the field and sold what they called “hope in a bottle,” that is, they apparently were hoping consumers would believe their advertising and purchase what were essentially emollients designed to help hydrate the skin and thus eliminate the appearance of some fine lines and dryness. Fortunately, times have changed. Thanks to medical research in the aesthetic skin care field, much more is now known about how the skin ages, and ingredients have been developed that slow down, and in some cases, partially reverse, some of the key signs of photoaging. This prompts the question, How can skin care professionals evaluate these ingredients and choose appropriate products for their patients? Quantity of Peer-Reviewed Evidence One of the best ways to evaluate the vast array of drugs approved to treat a given condition is by ranking ingredients according to both the quantity and quality of peer-reviewed evidence published in the medical literature, a process that involves scrutiny of experimental materials, methodology and data to insure reproducibility. When such standards are applied to products that are promoted to skin care professionals, a sense of organization emerges that can serve as a kind of screening tool. The chart shown in Figure 1 is a ranking of various topical active ingredients based on a quantitative review of available Medline data. Proven Options Without question, retinoids represent the “gold standard” for the treatment of photoaging based on the sheer quantity of peer-reviewed evidence. Note that it is also the only category that includes products specifically approved by the FDA for the treatment of this indication. Following retinoids are hydroxyacids, which have established themselves as safe and effective for managing certain signs of superficial photoaging, but with less profound biological effects than retinoids. Topical anti-oxidants are next on the list but they are supported by far less peer-reviewed evidence than retinoids and hydroxyacids. Unsubstantiated Claims Beyond topical anti-oxidants are additional popular skin care ingredients for which little objective, peer-reviewed evidence is available. Note that some products in these categories are heavily promoted as miraculous skin rejuvenating agents and sell for high prices, but in reality, there exists little proof that they are safe and effective. While claims like “20% reduction in fine lines” sound impressive, such benefits can usually be achieved through routine use of a simple moisturizing sunscreen. Bottom Line Given that for around $60 your patients can purchase a tube of generic tretinoin cream, which is proven safe and effective and is even approved by the FDA for treating photoaging, skin care professionals should make sure to get some hard evidence showing that that new highly touted $120 cosmeceutical is twice as good as that generic tretinoin cream. Dose-Response and Stability Evidence Dose-Response Studies — Effective Concentration Once it has been determined where a product ranks in terms of quality of peer-reviewed evidence of the safety, efficacy and cost-effectiveness of its active constituents, the question becomes, Does the product contain enough of this ingredient to have a biological effect? This relationship between concentration and effectiveness is determined by dose-response studies. Consequently, precise information on concentration is critical to determining if a product is worth using. As far as retinol is concerned, it’s usually used in concentrations from about 0.1% to 1%, with the higher strengths being more effective but potentially more irritating. With this information, it’s clear that a product containing 0.001% retinol is not going to do much. Stability Evidence — Possible Loss of Effectiveness As if skin care decision-making isn’t complicated enough, consider that many of the actives in cosmeceutical products, such as retinol, vitamin C and kojic acid, are sensitive to oxygen, light and heat and have poor stability in aqueous media. While such ingredients may start out at a sufficient concentration to have a meaningful biological effect, they can degrade fairly quickly to render the product sub-potent before or during use. Good examples are solutions of vitamin C; such solutions must be crystal clear and colorless. When these solutions turn yellow, brown or black, these color changes indicate the presence of oxidized ascorbic acid. So when a manufacturer claims such color changes don’t represent a problem, request a study proving that these oxides have the same efficacy as pure, unoxidized vitamin C. Since the science suggests that ascorbic acid oxides no longer react with free radicals and thus aren’t very good anti-oxidants, it is unlikely you will receive one. How to Ascertain Product Quality — Where HPLC Comes In A great way skin care professionals can assure themselves of the potency of cosmeceutical actives is to request from the manufacturer an HPLC (High Performance Liquid Chromatography) stability study of the product in question. HPLC is based on the chemical principle that molecules can be separated from each other based on differences in their affinities for a common material. With HPLC, that material is usually in the form of specially coated beads packed into a chromatography column. By comparing with a known standard the characteristics of samples before and after entering the column, such as how they absorb a beam of ultraviolet light, it’s possible to determine the presence and concentration of various actives quickly, economically and with a very high degree of precision. For this reason, HPLC is the most commonly used analytical method in the pharmaceutical industry, and all reputable skin care product manufacturers have HPLC instrumentation in their labs. It is also important to look at the stability of a product when stored at warm temperatures commonly experienced when it’s shipped during summer months or after its container is opened and the product is partly used. (In general, the more “head space” of air, the more oxygen exposure and potential oxidation.) All of these details are relevant and can make a difference between effective and ineffective treatments. Conclusion In conclusion, skin care products can be evaluated by first identifying their active components and their concentration, confirming stability and considering the quality of peer-reviewed evidence supporting their safety, efficacy and cost-effectiveness. Taking the time to learn this information from manufacturers will help skin care professionals provide their patients with the best possible treatments. John E. Kulesza is founder and president of Young Pharmaceuticals, Inc., a 32-year old firm based in Hartford, CT. that develops and markets proprietary dermatology products to dispensing physicians. Mr. Kulesza, an industrial chemist by training, holds several U.S. patents on dermatological technologies. Disclosure: John E. Kulesza is founder and president of Young Pharmaceuticals, Inc.
