A Multi-Mechanism Skin Brightening Regimen Delivers
Transcription
A Multi-Mechanism Skin Brightening Regimen Delivers
A Multi-Mechanism Skin Brightening Regimen Delivers Pigment Evening Benefits in an Ethnically Diverse Population Brenda L. Edison BA, Barbara A. Green RPh, MS, Lisa Buckley BA, Irina Brouda MA, Peter N. Konish MS, Yaling Lee PhD, Ronni L. Weinkauf PhD NeoStrata Company, Inc., Princeton, NJ, USA Introduction Objective To evaluate the tolerability and lightening / brightening benefits of a high-strength twicedaily skincare regimen in normally pigmented and hyperpigmented skin in an ethnically diverse population of women with uneven facial pigmentation. Study Methodology Subject Demographics 100 Subjects (n) 30 Gender Female Age, mean (range) Percentage (%) that Agree Somewhat, Agree Very Much, Highly Agree Pigmentation irregularities are a major concern for many ethnic skin populations spanning the globe.1,2 Safe, effective, and aesthetically pleasing formulations that can even skin color, brighten skin tone, and reduce dark spots are requested by dermatology patients around the world.3 A new brightening skincare regimen was developed to improve the complexion of facial skin by targeting multiple steps and pathways that affect pigmentation. The regimen consists of a facial cleanser, serum, and lotion, which contain N-Acetylglucosamine4 plus a variety of other benefit ingredients to collectively exfoliate pigmented areas, reduce tyrosinase activity and melanin production, and deliver an overall pigment evening effect. 50 (37–60) Race/Ethnicity, n (%) Latin American 14 (47%) Caucasian 10 (33%) Pacific Rim Asian 3 (10%) African American 2 (7%) Indian 1 (3%) Population / Inclusion Criteria Women, 30–60 years old, Fitzpatrick skin types I-IV, all ethnicities, with areas of mild to moderate facial hyperpigmentation (3–7 on a 10 cm visual analog scale), epidermal in nature (confirmed by Wood’s Lamp), willing to limit sun exposure and not change hormonal medications Exclusion Criteria Allergies to skincare product ingredients; use of hydroxyacids, retinol, hydroquinone, kojic acid and other antiaging or lightening/brightening cosmetics within last 2 months; cosmetic procedures or routine use of antiaging or skin brightening topical medications, including prescription retinoids, within last 6 months; planned or current pregnancy; breast-feeding Study Duration 16 weeks Study Regimen Twice a day use of the cleanser, serum, and lotion on the entire face (standard facial sunscreen provided for as needed use) Evaluation Visits Weeks 0, 4, 8, and 16 Evaluation Tools – Visual grading by a trained clinical grader using a 10 cm visual analog scale from extremely uneven skin tone (0) to even skin tone (10) • Objective – Chromameter measurements of brightness (L*) and sallowness (yellow hue, b*) of normally pigmented and hyperpigmented areas (weeks 0, 8, and 16 only) – Digital clinical photographs of the face • Subjective – Subject self-assessment questionnaires • 4% N-Acetylglucosamine (NeoGlucosamine®)a,b • Swiss alpine plant extracts (GigaWhite®)b,c • 4% N-Acetylglucosamine (NeoGlucosamine)a,b • Swiss alpine plant extracts (GigaWhite)b,c erum S (NeoStrata® Enlighten Illuminating Serum) • Oligopeptide-34b,c • Tetrahexyldecyl Ascorbate (Vitamin C)b,c Week 8 40 Week 16 30 20 10 0 n=30 Skin is more evenly colored Brown spots are less apparent Skin has better clarity / radiance 5a Subject photographs (Figs. 3, 4, and 5) show lighter and more even skin color, a brighter overall skin tone, and less apparent brown spots after regimen use. – Brightness (L*): • N ormally pigmented skin achieved fast improvement in brightness (week 8, 16), P<0.01 • H yperpigmented skin achieved strong improvement in brightness by week 16, P<0.01 • N ormally pigmented skin and hyperpigmented skin achieved comparable increases in brightness by week 16 5c otion L (NeoStrata® Enlighten Pigment Controller) Week 0 Normally Pigmented Skin Week 8 63 *† * Week 16 3a Baseline 62 61 60 59 58 57 *† †‡ A new multi-ingredient brightening skincare regimen was tested in an ethnically diverse sample of women with uneven facial pigmentation. Women applied the regimen to the entire face twice a day for 16 weeks. 3b Week 16 Visual grading and clinical photographs showed: Lighter and more even skin color Brighter overall skin tone Reduced overall sallowness Lighter and less apparent brown spots Effects were observed in all ethnic groups Figure 4. Hyperpigmented Skin Chromameter analyses of normally pigmented areas and brown spots showed that: Both normally pigmented areas and brown spots became brighter and less sallow Normally pigmented areas brightened faster than brown spots Brown spots improved in sallowness faster and to a greater degree than normally pigmented areas Decreased Sallowness 56 19 18 Yellow b* values 17 16 Self-assessment questionnaires confirmed that subjects noticed brighter skin tone, more even pigmentation, and less apparent brown spots Subject Self-Assessment • Ascorbyl Glucoside (Vitamin C)b,c • T etrahydrodiferuloylmethane (curcumin analogue found naturally in tumeric, SabiWhite®)b,c Subjects reported more even pigmentation, less obvious brown spots, and improved clarity and radiance at each post-baseline visit (Fig. 2) Exfoliant; bTyrosinase Inhibitor; cMelanin Reducer a Week 16 For the subject in Figure 5 above, note improvement in pigmentation in standard lighting photographs (5a, 5b) and in cross-polarized photographs with melanin imaging applied to visualize hyperpigmented areas (5c, 5d). Summary 64 Subjects reported brighter overall skin tone during regimen use: – 60% of subjects noticed an improvement as early as 2 weeks – 9 0% of subjects rated excellent, very good or good improvement after 16 weeks • 0.1% Retinolb,c 5d Baseline • Licorice Extractb • Swiss alpine plant extracts (GigaWhite)b,c Week 16 Figure 3. Figure 1. Improvement in Brightness and Sallowness of Normally Pigmented and Hyperpigmented Skin • Eucommia Ulmoides Leaf Extract (source of chlorogenic acid)c • 6% N-Acetylglucosamine (NeoGlucosamine) a,b 5b Baseline – Sallowness (b*) • N ormally pigmented skin was significantly less sallow at week 16, P<0.01 • H yperpigmented skin was significantly less sallow at weeks 8 and 16, P<0.01 • H yperpigmented skin achieved a significantly greater reduction in sallowness than normally pigmented skin at week 8, P<0.05 Luminance L* values Key Benefit Ingredients leanser C (NeoStrata® Enlighten Ultra Brightening Cleanser) Week 4 50 Normally pigmented skin and hyperpigmented skin (brown spots) showed significantly increased brightness and decreased sallowness (Fig. 1): Observed and reported adverse events Product 60 Clinical Photography – Chromameter change from baseline comparisons for hyperpigmented vs normally pigmented skin using paired t-tests at P<0.05 Study Products 80% 77% Chromameter Measurements – Tabulation of subject self-assessment scores Safety 80% 70 Significant improvement in evenness of skin tone was observed at every post-baseline visit (weeks 4, 8, and 16, P<0.0001) – Before and after treatment comparisons of visual grading scores and chromameter measurements using ANOVA followed by a Dunnett’s test at P<0.05 Statistics 80 The high-strength regimen was well-tolerated. Adverse reactions were mild (n=3) to moderate (n=3) localized skin irritation, mostly within the first 2 weeks of use, and may have been due to twice-daily use of retinol without an acclimation phase. Reactions were distributed across ethnicities. Increased Brightness Single-group, prospective skincare regimen use study with direct comparisons to baseline 90 Tolerability Visual Grading 93% of users achieved a more even skin tone after the first 4 weeks Study Design Figure 5. Figure 2. Subject Self-Assessment of Improvement in Skin Pigmentation Results References 1. 2. 3. 4. 4a Baseline 4b Week 16 Cole PD, Hatef DA, Taylor S, Bullocks JM. Skin care in ethnic populations. Semin Plast Surg. 2009 Aug;23(3):168-72. Grimes PE. Management of hyperpigmentation in darker racial ethnic groups. Semin Cutan Med Surg. 2009 Jun;28(2):77-85. Taylor SC. Cosmetic problems in skin of color. Skin Pharmacol Appl Skin Physiol. 1999 May-Jun;12(3):139-43. Hwang JS, Lee HY, Lim TY, Kim MY, Yoon TJ. Disruption of tyrosinase glycosylation by N-acetylglucosamine and its depigmenting effects in guinea pig skin and in human skin. J Dermatol Sci. 2011 Sep;63(3):199-201. Poster presented at the 21st Congress of the European Academy of Dermatology & Venereology, Prague, Czech Republic, 27–30 September, 2012 Study sponsored by NeoStrata Company, Inc., Princeton, NJ, USA P248 A Multi-Mechanism Skin Brightening Regimen Delivers Pigment Evening Benefits in an Ethnically Diverse Population Brenda L. Edison BA Barbara A. Green RPh, MS Lisa Buckley BA Irina Brouda MA Peter N. Konish MS Yaling Lee PhD Ronni L. Weinkauf PhD NeoStrata Company, Inc., Princeton, NJ, USA 21st Congress of the European Academy of Dermatology & Venereology Prague, Czech Republic, 27-30 September, 2012 P248 Introduction Results Pigmentation irregularities are a major concern for many ethnic skin populations spanning the globe.1,2 Safe, effective, and aesthetically pleasing formulations that can even skin color, brighten skin tone, and reduce dark spots are requested by dermatology patients around the world.3 A new brightening skincare regimen was developed to improve the complexion of facial skin by targeting multiple steps and pathways that affect pigmentation. The regimen consists of a facial cleanser, serum, and lotion, which contain N-Acetylglucosamine4 plus a variety of other benefit ingredients to collectively exfoliate pigmented areas, reduce tyrosinase activity and melanin production, and deliver an overall pigment evening effect. Objective To evaluate the tolerability and lightening / brightening benefits of a high-strength twicedaily skincare regimen in normally pigmented and hyperpigmented skin in an ethnically diverse population of women with uneven facial pigmentation. Study Methodology Subject Demographics Subjects (n) 30 Gender Fem Age, mean (range) 50 ( Race/Ethnicity, n (%) Latin American 14 ( Caucasian 10 ( Pacific Rim Asian 3 (1 African American 2 (7 Indian 1 (3 Visual Grading 93% of users achieved a more even sk Single-group, prospective skincare regimen use study with direct comparisons to baseline Population / Inclusion Criteria Women, 30–60 years old, Fitzpatrick skin types I-IV, all ethnicities, with areas of mild to moderate facial hyperpigmentation (3–7 on a 10 cm visual analog scale), epidermal in nature (confirmed by Wood’s Lamp), willing to limit sun exposure and not change hormonal medications Exclusion Criteria Allergies to skincare product ingredients; use of hydroxyacids, retinol, hydroquinone, kojic acid and other antiaging or lightening/brightening cosmetics within last 2 months; cosmetic procedures or routine use of antiaging or skin brightening topical medications, including prescription retinoids, within last 6 months; planned or current pregnancy; breast-feeding Study Duration 16 weeks Study Regimen Twice a day use of the cleanser, serum, and lotion on the entire face (standard facial sunscreen provided for as needed use) Evaluation Visits Weeks 0, 4, 8, and 16 Evaluation Tools – Visual grading by a trained clinical grader using a 10 cm visual analog scale from extremely uneven skin tone (0) to even skin tone (10) • Objective – Chromameter measurements of brightness (L*) and sallowness (yellow hue, b*) of normally pigmented and hyperpigmented areas (weeks 0, 8, and 16 only) – Digital clinical photographs of the face • Subjective – Subject self-assessment questionnaires Significant improvement in evenness o visit (weeks 4, 8, and 16, P<0.0001) Chromameter Measurements Normally pigmented skin and hyperpig increased brightness and decreased s – Brightness (L*): • Normally pigmented skin achieve P<0.01 • Hyperpigmented skin achieved st P<0.01 • Normally pigmented skin and hyp in brightness by week 16 – Sallowness (b*) • Normally pigmented skin was sig • Hyperpigmented skin was signific • Hyperpigmented skin achieved a normally pigmented skin at week – Before and after treatment comparisons of visual grading scores and chromameter measurements using ANOVA followed by a Dunnett’s test at P<0.05 Statistics Figure 1. Improvement in Normally Pigmented – Chromameter change from baseline comparisons for hyperpigmented vs normally pigmented skin using paired t-tests at P<0.05 – Tabulation of subject self-assessment scores Study Products Product Key Benefit Ingredients Cleanser (NeoStrata® Enlighten Ultra Brightening Cleanser) • 4% N-Acetylglucosamine (NeoGlucosamine®)a,b • Swiss alpine plant extracts (GigaWhite®)b,c • 4% N-Acetylglucosamine (NeoGlucosamine)a,b • Swiss alpine plant extracts (GigaWhite)b,c Serum (NeoStrata® Enlighten Illuminating Serum) 64 Observed and reported adverse events • Oligopeptide-34b,c • Tetrahexyldecyl Ascorbate (Vitamin C)b,c Week 0 Week 8 63 Luminance L* values Safety Week 16 62 Increased Brightness Study Design 61 60 59 58 57 Decrea 56 19 18 • Eucommia Ulmoides Leaf Extract (source of chlorogenic acid)c Y • Licorice Extractb • 6% N-Acetylglucosamine (NeoGlucosamine) a,b Lotion (NeoStrata® Enlighten Pigment Controller) Subject Self-Assessment • Ascorbyl Glucoside (Vitamin C)b,c Subjects reported brighter overall skin – 60% of subjects noticed an improve – 90% of subjects rated excellent, ver 16 weeks • Tetrahydrodiferuloylmethane (curcumin analogue found naturally in tumeric, SabiWhite®)b,c Subjects reported more even pigment clarity and radiance at each post-bas • Swiss alpine plant extracts (GigaWhite)b,c • 0.1% Retinol b,c Exfoliant; bTyrosinase Inhibitor; cMelanin Reducer a P248 gimen use study with direct comparisons to baseline skin types I-IV, all ethnicities, with areas of mild to –7 on a 10 cm visual analog scale), epidermal in willing to limit sun exposure and not change nts; use of hydroxyacids, retinol, hydroquinone, kojic /brightening cosmetics within last 2 months; cosmetic g or skin brightening topical medications, including onths; planned or current pregnancy; breast-feeding m, and lotion on the entire face or as needed use) rader using a 10 cm visual analog scale from en skin tone (10) ghtness (L*) and sallowness (yellow hue, b*) gmented areas (weeks 0, 8, and 16 only) ce aires Subject Demographics Subjects (n) 30 Gender Female Age, mean (range) 50 (37–60) Race/Ethnicity, n (%) Latin American 14 (47%) Caucasian 10 (33%) Pacific Rim Asian 3 (10%) African American 2 (7%) Indian 1 (3%) nt extracts (GigaWhite)b,c ,c Ascorbate (Vitamin C)b,c osamine (NeoGlucosamine) a,b 60 50 40 30 20 10 0 Skin is more evenly colored Bro are le Clinical Photography Normally pigmented skin and hyperpigmented skin (brown spots) showed significantly increased brightness and decreased sallowness (Fig. 1): Subject photographs (Figs. 3, 4, and 5 overall skin tone, and less apparent br – Brightness (L*): • Normally pigmented skin achieved fast improvement in brightness (week 8, 16), P<0.01 • Hyperpigmented skin achieved strong improvement in brightness by week 16, P<0.01 • Normally pigmented skin and hyperpigmented skin achieved comparable increases in brightness by week 16 F – Sallowness (b*) • Normally pigmented skin was significantly less sallow at week 16, P<0.01 • Hyperpigmented skin was significantly less sallow at weeks 8 and 16, P<0.01 • Hyperpigmented skin achieved a significantly greater reduction in sallowness than normally pigmented skin at week 8, P<0.05 Figure 1. Improvement in Brightness and Sallowness of Normally Pigmented and Hyperpigmented Skin 64 Week 0 Luminance L* values Normally Pigmented Skin Week 8 63 *† * Week 16 3a Baseline 62 61 60 59 58 57 *† †‡ F Hyperpigmented Skin Decreased Sallowness 56 19 18 des Leaf Extract (source of chlorogenic acid)c Yellow b* values 17 16 Subject Self-Assessment de (Vitamin C)b,c Subjects reported brighter overall skin tone during regimen use: – 60% of subjects noticed an improvement as early as 2 weeks – 90% of subjects rated excellent, very good or good improvement after 16 weeks oylmethane (curcumin analogue found ic, SabiWhite®)b,c Subjects reported more even pigmentation, less obvious brown spots, and improved clarity and radiance at each post-baseline visit (Fig. 2) nt extracts (GigaWhite)b,c 70 Chromameter Measurements ts osamine (NeoGlucosamine)a,b 80% Significant improvement in evenness of skin tone was observed at every post-baseline visit (weeks 4, 8, and 16, P<0.0001) nt scores nt extracts (GigaWhite®)b,c 80 The high-strength regimen was well-to moderate (n=3) localized skin irritation have been due to twice-daily use of re were distributed across ethnicities. 93% of users achieved a more even skin tone after the first 4 weeks comparisons for hyperpigmented vs normally at P<0.05 osamine (NeoGlucosamine®)a,b 90 Tolerability Visual Grading sons of visual grading scores and chromameter ed by a Dunnett’s test at P<0.05 dients 100 Percentage (%) that Agree Somewhat, Agree Very Much, Highly Agree ning benefits of a high-strength twicehyperpigmented skin in an ethnically gmentation. Figure 2. Subje Improvement Results Increased Brightness many ethnic skin populations spanning ing formulations that can even skin e requested by dermatology patients men was developed to improve steps and pathways that affect nser, serum, and lotion, which contain fit ingredients to collectively exfoliate elanin production, and deliver an overall NeoStrata Company, Inc., Princeton, NJ, USA 4a Baseline P248 NeoStrata Company, Inc., Princeton, NJ, USA F Figure 2. Subject Self-Assessment of Improvement in Skin Pigmentation Percentage (%) that Agree Somewhat, Agree Very Much, Highly Agree 100 90 80 80% 80% 77% 70 60 Week 4 50 Week 8 40 Week 16 30 20 10 0 n=30 Skin is more evenly colored Brown spots are less apparent Skin has better clarity / radiance 5a Tolerability ter the first 4 weeks e was observed at every post-baseline Baseline The high-strength regimen was well-tolerated. Adverse reactions were mild (n=3) to moderate (n=3) localized skin irritation, mostly within the first 2 weeks of use, and may have been due to twice-daily use of retinol without an acclimation phase. Reactions were distributed across ethnicities. Clinical Photography kin (brown spots) showed significantly (Fig. 1): Subject photographs (Figs. 3, 4, and 5) show lighter and more even skin color, a brighter overall skin tone, and less apparent brown spots after regimen use. Figure 3. rovement in brightness (week 8, 16), ovement in brightness by week 16, ted skin achieved comparable increases ess sallow at week 16, P<0.01 sallow at weeks 8 and 16, P<0.01 ly greater reduction in sallowness than 5c Baseline For the subject in Figure 5 above, n lighting photographs (5a, 5b) and in cr applied to visualize h ness and Sallowness of yperpigmented Skin Summary Normally Pigmented Skin *† * 3a Baseline *† A new multi-ingredient brightening sk diverse sample of women with uneve regimen to the entire face twice a da 3b Week 16 Visual grading and clinical photogra Lighter and more even skin color Brighter overall skin tone Reduced overall sallowness Lighter and less apparent brown Effects were observed in all ethni Figure 4. Hyperpigmented Skin Chromameter analyses of normally showed that: Both normally pigmented areas a Normally pigmented areas brighte Brown spots improved in sallown pigmented areas wness lues 17 16 Self-assessment questionnaires con more even pigmentation, and less app References ng regimen use: arly as 2 weeks good improvement after s obvious brown spots, and improved Fig. 2) 1. 2. 3. 4. 4a Baseline 4b Week 16 Cole PD, Hatef DA, Taylor S, Bullocks JM. Skin care in ethni Grimes PE. Management of hyperpigmentation in darker rac Taylor SC. Cosmetic problems in skin of color. Skin Pharmac Hwang JS, Lee HY, Lim TY, Kim MY, Yoon TJ. Disruption of t in guinea pig skin and in human skin. J Dermatol Sci. 2011 S Poster presented at the 21st Congress of the European A & Venereology, Prague, Czech Republic, 27–30 Septemb Study sponsored by NeoStrata Company, Inc., Princeton P248 S, Yaling Lee PhD, Ronni L. Weinkauf PhD Figure 5. f-Assessment of n Pigmentation t 80% Week 4 Week 8 Week 16 n=30 Skin has better clarity / radiance 5a 5b Baseline Adverse reactions were mild (n=3) to within the first 2 weeks of use, and may out an acclimation phase. Reactions Week 16 hter and more even skin color, a brighter s after regimen use. 3. 5c Baseline Week 16 For the subject in Figure 5 above, note improvement in pigmentation in standard lighting photographs (5a, 5b) and in cross-polarized photographs with melanin imaging applied to visualize hyperpigmented areas (5c, 5d). Summary A new multi-ingredient brightening skincare regimen was tested in an ethnically diverse sample of women with uneven facial pigmentation. Women applied the regimen to the entire face twice a day for 16 weeks. Week 16 Visual grading and clinical photographs showed: Lighter and more even skin color Brighter overall skin tone Reduced overall sallowness Lighter and less apparent brown spots Effects were observed in all ethnic groups 4. Week 16 5d Chromameter analyses of normally pigmented areas and brown spots showed that: Both normally pigmented areas and brown spots became brighter and less sallow Normally pigmented areas brightened faster than brown spots Brown spots improved in sallowness faster and to a greater degree than normally pigmented areas Self-assessment questionnaires confirmed that subjects noticed brighter skin tone, more even pigmentation, and less apparent brown spots References 1. 2. 3. 4. Cole PD, Hatef DA, Taylor S, Bullocks JM. Skin care in ethnic populations. Semin Plast Surg. 2009 Aug;23(3):168-72. Grimes PE. Management of hyperpigmentation in darker racial ethnic groups. Semin Cutan Med Surg. 2009 Jun;28(2):77-85. Taylor SC. Cosmetic problems in skin of color. Skin Pharmacol Appl Skin Physiol. 1999 May-Jun;12(3):139-43. Hwang JS, Lee HY, Lim TY, Kim MY, Yoon TJ. Disruption of tyrosinase glycosylation by N-acetylglucosamine and its depigmenting effects in guinea pig skin and in human skin. J Dermatol Sci. 2011 Sep;63(3):199-201. Poster presented at the 21st Congress of the European Academy of Dermatology & Venereology, Prague, Czech Republic, 27–30 September, 2012 Study sponsored by NeoStrata Company, Inc., Princeton, NJ, USA P248 P248