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Kerato-regulating care for infantile seborrheic dermatitis
P906
P908
A double-blind, randomized clinical trial evaluating the dermatologic benefits of coffee berry extract Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC, United States
TNF-alpha and IL-6 regulate collagen 1 and MMP-1 in dermal fibroblasts. Bicyclic monoterpene diols suppress MMP-1 secretion and increase collagen production through TNF-alpha signaling Kelly Dong, MS, AGI Dermatics, Freeport, NY, United States; Nelli Markova, PhD, AGI Dermatics, Freeport, NY, United States; Kenneth Smiles, PhD, AGI Dermatics, Freeport, NY, United States; Daniel Yarosh, PhD, AGI Dermatics, Freeport, NY, United States The aging of the skin is associated with loss of collagen 1 and with increasing secretion of the collagenase responsible for its degradation, MMP-1, in the dermal fibroblasts. Both collagen and MMP-1 content in the dermis is controlled at RNA and protein levels by cytokine signaling that can be modulated by various low molecular weight compounds. We have shown that an equimolar mixture of the bicyclic monoterpene diols (BMTd) 2,3-cis/exo-pinanediol and 2,3-cis/exo-camphanediol increases collagen gene expression and protein production while decreasing MMP1 secretion in dermal fibroblasts in a dose-dependent mode. In the same range of BMTd concentrations, we observed a linear increase in interleukin-6 (IL-6) secretion. Since IL-6 has been reported to be involved in collagen deposition during keloid formation, this suggests that IL-6 may be involved in the modulation of collagen and MMP-1 secretion in response to BMTd. Blocking IL-6 signaling with a neutralizing IL6 antibody concomitantly increased MMP-1 and reduced collagen 1 secretion. The effect of the neutralizing antibody, however, was gradually eliminated by increasing BMTd concentrations, indicating that IL-6 is not involved in the transmission of the BMTd effect. Similar to IL-6, blocking TNF-a signaling in the fibroblasts with a TNF-a neutralizing antibody increases MMP-1 and decreases collagen 1 secretion. Blocking TNF-a signaling, however, also blocks the BMTd effect. Our results indicate that in dermal fibroblasts both IL-6 and TNF-a are involved in collagen 1 and MMP1 secretion. The ability of BMTd to stimulate collagen 1 and reduce collagenase MMP-1 secretion depends only on the TNF-a signaling.
Introduction: Coffee berry extract is reported to have strong antioxidative properties and may be helpful in improving the appearance of photoaged skin. Methods: A total of 50 subjects at least 30 years of age with mild to moderate photoaging were randomly assigned into one of two groups. After washing their face twice daily with coffee berry cleanser, one group applied coffee berry day cream (A.M.) and coffee berry night cream (P.M.) to their entire face for 12 weeks. The other group followed the same regimen using control cleanser, control day cream, and control night cream. Photoaging was evaluated in terms of roughness, erythema, wrinkling, scaling, and global assessment every 3 weeks (using a scale of none, minimal, mild, moderate, moderately severe, or severe). The primary efficacy endpoint was an investigator-assessed improvement in the global assessment of the skin that was statistically significant at week 12 compared with baseline. Irritation was assessed using the same scale, and additional objective assessments included transepidermal water loss (TEWL) and corneometry. Results: All 50 subjects completed the study. Relative to the control group, significant improvements were reported in the coffee berry extract group in terms of roughness (P # .05 from week 6 onward), erythema (P # .01 from week 6 onward), wrinkling (P #.01 from week 9 onward), global assessment (P #.01 from week 9 onward), and scaling (P # .05 at week 12). At all timepoints, TEWL was reduced from baseline in the coffee berry extract group (reflecting improved barrier function) and increased in the control group (reflecting reduced barrier function). The between group difference in the change in TEWL was significant at all timepoints (P # .002). Corneometer assessments showed no significant betweengroup differences in skin hydration. An absence of erythema and irritation at week 12 (the primary tolerability endpoint) was achieved in all patients. Conclusions: The coffee berry extract skin care system (cleanser, day cream, and night cream) achieves significant improvements in roughness, erythema, wrinkling, scaling, and TEWL when applied to photoaged skin and is well tolerated. The benefits increase with the duration of use, suggesting continued improvement over time. An extended study is planned to further evaluate the benefits of longer term use.
Commercial support: None identified.
Supported by Stiefel Laboratories.
P907 Kerato-regulating care for infantile seborrheic dermatitis Clarence de Belilovsky, MD, Institut Alfred Fournier, Paris, France; Bernard Chadoutaud, ClinReal Online, Toulouse, France; Philippe Msika, Laboratoires Expanscience, Epernon, France Introduction: Infantile seborrheic dermatitis (ISD) affects almost two-thirds of newborns, mostly on the scalp, and is known as cradle cap. Its physiopathology is still debated, including hyperseborrhea, proliferation of M furfur, and inflammation. A kerato-regulating care has been formulated with patented active ingredients to impact all the components of IDS. It contains alpha-hydroxy acid (AHA) esters, butylavocadate with antiseborrheic properties, capryloyl-glycine complex to limit the proliferation of microorganisms (Malassezia), aloe vera, and bourrache oil with soothing and antiinflammatory properties. This product has been tested on babies from two different European countries.
P910 Interim analysis of a study evaluating a smooth consistency hyaluronic acid gel for improvement of nasolabial folds in subjects previously treated with a different hyaluronic acid filler Jessica Wu, MD, University of Southern California, Los Angeles, CA, United States
Conclusion: A patented cosmetic product has proven its efficacy for infantile seborrheic dermatitis in two European studies. It is recommended as a first line care for cradle cap, 7 or 3.5 days a week and acts rapidly (mean, 10.4 days total clearance).
The physical and chemical properties of hyaluronic acid (HA) dermal fillers can impact duration of effect and natural appearance. A newer generation of HA-based fillers is manufactured with an innovative process yielding a smooth gel with uniform consistency and improved flow characteristics resulting in a product that is easy to inject. These fillers, containing high HA concentrations (24 mg/mL) and a high degree of crosslinking (6%-8%), became available to the US market in 2006. A single-center, open-label, historical crossover study was conducted to evaluate effectiveness and patient satisfaction following treatment of moderate (67%) to severe (33%) nasolabial folds (NLFs) with the newer 24 mg/mL HA dermal filler. Thirty subjects who had previously been treated with a different nonanimal stabilized HA (20 mg/mL gel particle suspension) within the previous year (mean of 9 mos) and whose treatment effects had completely diminished, were eligible. The injection volume for the 24 mg/mL HA filler was limited to equal to or less than that of the previous HA filler. Touch-ups were not allowed. Physicians recorded subjects’ perceptions of the previous HA filler treatment at baseline, as well as effectiveness and patient satisfaction measures for the 24 mg/mL HA gel at 2 weeks, and 3, 6, and 9 months. We recognize the potential for bias in making direct comparisons based on subjects’ recollections and instead we are focusing on the diminishing effects of both treatments over time in a real-world setting. This interim analysis reports data through 3 months. At baseline, patients reported a mean duration of 4.1 months until no longer satisfied with the effect of the previous HA filler. Although less volume of the 24 mg/mL HA gel was used (mean, 1.41 cc vs. 1.81 cc for the previous filler), 93% of subjects remained satisfied at 3 months. The majority of patients experienced no postinjection pain, bruising, redness, or swelling. Physicians rated the overall appearance as smooth (100%), the overall feel as natural (100%), and NLF severity as none or mild (86.2%) through 3 months. Compared with the previous 20 mg/mL gel particle suspension, patients reported that the new 24 mg/mL gel gave better overall improvement in NLFs (96.6%), lasted longer (82.7%), and was preferred for their next treatment (93%).
Commercial support: None identified.
100% sponsored by Allergan, Inc.
Material and methods: The first study was conducted in Germany by 3 dermatologists and 3 gynecologists together recruiting 30 children (mean age, 22.4 mos) with light to moderate cradle cap (initial score 3.1 on a 10-step scale). The tested product was applied every evening with shampoo every morning on 30% of children and one every other night on the other 70%. The second study took place in Spain with 33 younger babies (mean age, 5.2 mos) affected by more severe cradle cap (initial score 4 to 5) recruited by 8 pediatric nurses. Product was applied every evening. The two studies lasted 15 days with clinical investigations at baseline (day 0) and day 15. Results were analyzed by nonparametric Wilcoxon test for the second study. Results: Results are in the same range for the two studies. Total clearance of the scales: 49% first study/52% second study (mean delay calculated for the second study, 10.4 days); investigator global assessment: 87%/82% (P ¼ .03 vs. day 0) efficacy; scales severity: 81%/73% (P \ .01 vs. day 0) improvement; erythema severity: 100%/85% (P \.01 vs. day 0) improvement; pruritus: 80%/83% (P \.01 vs. day 0) decrease. Parents’ assessments were similar: 63%/75% for the scales elimination. Cosmetics properties were the following: light texture: 97%/97%; easy cleansing: 97%/97%; nonirritating: 93%/97%.
AB64
J AM ACAD DERMATOL
FEBRUARY 2008
P908
A double-blind, randomized clinical trial evaluating the dermatologic benefits of coffee berry extract Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC, United States
TNF-alpha and IL-6 regulate collagen 1 and MMP-1 in dermal fibroblasts. Bicyclic monoterpene diols suppress MMP-1 secretion and increase collagen production through TNF-alpha signaling Kelly Dong, MS, AGI Dermatics, Freeport, NY, United States; Nelli Markova, PhD, AGI Dermatics, Freeport, NY, United States; Kenneth Smiles, PhD, AGI Dermatics, Freeport, NY, United States; Daniel Yarosh, PhD, AGI Dermatics, Freeport, NY, United States The aging of the skin is associated with loss of collagen 1 and with increasing secretion of the collagenase responsible for its degradation, MMP-1, in the dermal fibroblasts. Both collagen and MMP-1 content in the dermis is controlled at RNA and protein levels by cytokine signaling that can be modulated by various low molecular weight compounds. We have shown that an equimolar mixture of the bicyclic monoterpene diols (BMTd) 2,3-cis/exo-pinanediol and 2,3-cis/exo-camphanediol increases collagen gene expression and protein production while decreasing MMP1 secretion in dermal fibroblasts in a dose-dependent mode. In the same range of BMTd concentrations, we observed a linear increase in interleukin-6 (IL-6) secretion. Since IL-6 has been reported to be involved in collagen deposition during keloid formation, this suggests that IL-6 may be involved in the modulation of collagen and MMP-1 secretion in response to BMTd. Blocking IL-6 signaling with a neutralizing IL6 antibody concomitantly increased MMP-1 and reduced collagen 1 secretion. The effect of the neutralizing antibody, however, was gradually eliminated by increasing BMTd concentrations, indicating that IL-6 is not involved in the transmission of the BMTd effect. Similar to IL-6, blocking TNF-a signaling in the fibroblasts with a TNF-a neutralizing antibody increases MMP-1 and decreases collagen 1 secretion. Blocking TNF-a signaling, however, also blocks the BMTd effect. Our results indicate that in dermal fibroblasts both IL-6 and TNF-a are involved in collagen 1 and MMP1 secretion. The ability of BMTd to stimulate collagen 1 and reduce collagenase MMP-1 secretion depends only on the TNF-a signaling.
Introduction: Coffee berry extract is reported to have strong antioxidative properties and may be helpful in improving the appearance of photoaged skin. Methods: A total of 50 subjects at least 30 years of age with mild to moderate photoaging were randomly assigned into one of two groups. After washing their face twice daily with coffee berry cleanser, one group applied coffee berry day cream (A.M.) and coffee berry night cream (P.M.) to their entire face for 12 weeks. The other group followed the same regimen using control cleanser, control day cream, and control night cream. Photoaging was evaluated in terms of roughness, erythema, wrinkling, scaling, and global assessment every 3 weeks (using a scale of none, minimal, mild, moderate, moderately severe, or severe). The primary efficacy endpoint was an investigator-assessed improvement in the global assessment of the skin that was statistically significant at week 12 compared with baseline. Irritation was assessed using the same scale, and additional objective assessments included transepidermal water loss (TEWL) and corneometry. Results: All 50 subjects completed the study. Relative to the control group, significant improvements were reported in the coffee berry extract group in terms of roughness (P # .05 from week 6 onward), erythema (P # .01 from week 6 onward), wrinkling (P #.01 from week 9 onward), global assessment (P #.01 from week 9 onward), and scaling (P # .05 at week 12). At all timepoints, TEWL was reduced from baseline in the coffee berry extract group (reflecting improved barrier function) and increased in the control group (reflecting reduced barrier function). The between group difference in the change in TEWL was significant at all timepoints (P # .002). Corneometer assessments showed no significant betweengroup differences in skin hydration. An absence of erythema and irritation at week 12 (the primary tolerability endpoint) was achieved in all patients. Conclusions: The coffee berry extract skin care system (cleanser, day cream, and night cream) achieves significant improvements in roughness, erythema, wrinkling, scaling, and TEWL when applied to photoaged skin and is well tolerated. The benefits increase with the duration of use, suggesting continued improvement over time. An extended study is planned to further evaluate the benefits of longer term use.
Commercial support: None identified.
Supported by Stiefel Laboratories.
P907 Kerato-regulating care for infantile seborrheic dermatitis Clarence de Belilovsky, MD, Institut Alfred Fournier, Paris, France; Bernard Chadoutaud, ClinReal Online, Toulouse, France; Philippe Msika, Laboratoires Expanscience, Epernon, France Introduction: Infantile seborrheic dermatitis (ISD) affects almost two-thirds of newborns, mostly on the scalp, and is known as cradle cap. Its physiopathology is still debated, including hyperseborrhea, proliferation of M furfur, and inflammation. A kerato-regulating care has been formulated with patented active ingredients to impact all the components of IDS. It contains alpha-hydroxy acid (AHA) esters, butylavocadate with antiseborrheic properties, capryloyl-glycine complex to limit the proliferation of microorganisms (Malassezia), aloe vera, and bourrache oil with soothing and antiinflammatory properties. This product has been tested on babies from two different European countries.
P910 Interim analysis of a study evaluating a smooth consistency hyaluronic acid gel for improvement of nasolabial folds in subjects previously treated with a different hyaluronic acid filler Jessica Wu, MD, University of Southern California, Los Angeles, CA, United States
Conclusion: A patented cosmetic product has proven its efficacy for infantile seborrheic dermatitis in two European studies. It is recommended as a first line care for cradle cap, 7 or 3.5 days a week and acts rapidly (mean, 10.4 days total clearance).
The physical and chemical properties of hyaluronic acid (HA) dermal fillers can impact duration of effect and natural appearance. A newer generation of HA-based fillers is manufactured with an innovative process yielding a smooth gel with uniform consistency and improved flow characteristics resulting in a product that is easy to inject. These fillers, containing high HA concentrations (24 mg/mL) and a high degree of crosslinking (6%-8%), became available to the US market in 2006. A single-center, open-label, historical crossover study was conducted to evaluate effectiveness and patient satisfaction following treatment of moderate (67%) to severe (33%) nasolabial folds (NLFs) with the newer 24 mg/mL HA dermal filler. Thirty subjects who had previously been treated with a different nonanimal stabilized HA (20 mg/mL gel particle suspension) within the previous year (mean of 9 mos) and whose treatment effects had completely diminished, were eligible. The injection volume for the 24 mg/mL HA filler was limited to equal to or less than that of the previous HA filler. Touch-ups were not allowed. Physicians recorded subjects’ perceptions of the previous HA filler treatment at baseline, as well as effectiveness and patient satisfaction measures for the 24 mg/mL HA gel at 2 weeks, and 3, 6, and 9 months. We recognize the potential for bias in making direct comparisons based on subjects’ recollections and instead we are focusing on the diminishing effects of both treatments over time in a real-world setting. This interim analysis reports data through 3 months. At baseline, patients reported a mean duration of 4.1 months until no longer satisfied with the effect of the previous HA filler. Although less volume of the 24 mg/mL HA gel was used (mean, 1.41 cc vs. 1.81 cc for the previous filler), 93% of subjects remained satisfied at 3 months. The majority of patients experienced no postinjection pain, bruising, redness, or swelling. Physicians rated the overall appearance as smooth (100%), the overall feel as natural (100%), and NLF severity as none or mild (86.2%) through 3 months. Compared with the previous 20 mg/mL gel particle suspension, patients reported that the new 24 mg/mL gel gave better overall improvement in NLFs (96.6%), lasted longer (82.7%), and was preferred for their next treatment (93%).
Commercial support: None identified.
100% sponsored by Allergan, Inc.
Material and methods: The first study was conducted in Germany by 3 dermatologists and 3 gynecologists together recruiting 30 children (mean age, 22.4 mos) with light to moderate cradle cap (initial score 3.1 on a 10-step scale). The tested product was applied every evening with shampoo every morning on 30% of children and one every other night on the other 70%. The second study took place in Spain with 33 younger babies (mean age, 5.2 mos) affected by more severe cradle cap (initial score 4 to 5) recruited by 8 pediatric nurses. Product was applied every evening. The two studies lasted 15 days with clinical investigations at baseline (day 0) and day 15. Results were analyzed by nonparametric Wilcoxon test for the second study. Results: Results are in the same range for the two studies. Total clearance of the scales: 49% first study/52% second study (mean delay calculated for the second study, 10.4 days); investigator global assessment: 87%/82% (P ¼ .03 vs. day 0) efficacy; scales severity: 81%/73% (P \ .01 vs. day 0) improvement; erythema severity: 100%/85% (P \.01 vs. day 0) improvement; pruritus: 80%/83% (P \.01 vs. day 0) decrease. Parents’ assessments were similar: 63%/75% for the scales elimination. Cosmetics properties were the following: light texture: 97%/97%; easy cleansing: 97%/97%; nonirritating: 93%/97%.
AB64
J AM ACAD DERMATOL
FEBRUARY 2008