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Long-term efficacy and tolerance of a sonic brush and salicylic acid cleanser for cleansing acneic skin
P7748
P8383
Efficacy and tolerance of a novel topical composition on persistent redness observed in patients treated with topical or oral therapy for papulopustular rosacea Hilary Baldwin, Sunny Downstate Medical Center, New York, NY, United States; Christian Oresajo, L’Oreal Res. & Innovation, Clark, NJ, United States; Diane Berson, New York - Presbyterian/Well Cornell, New York, NY, United States; Margarita Yatskayer, L’Oreal Res. & Innovation, Clark, NJ, United States; Nannan Chen, L’Oreal Res. & Innovation, Clark, NJ, United States; Yevgeniy Krol, Skinceuticals Inc, New York, North Dakota, United States
Long-term efficacy and tolerance of a sonic brush and salicylic acid cleanser for cleansing acneic skin Katherine Ortblad, MHS, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Greg Peterson, PhD, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Robb Akridge, PhD, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Zoe Draelos, PA, MD, Dermatology Consulting Services, High Point, NC, United States Introduction: The delicate, compromised skin found with specific skin conditions presents cleansing challenges. Removal of dirt, oil, & bacteria without harming the function of the skin barrier are important when cleansing the skin. Objective: To evaluate the safety & efficacy of an acne cleansing regimen (sonic skin care brush, brush head designed for cleansing acneic skin, & 2% salicylic acid cleanser).
Purpose of study: Objective was to determine the efficacy and tolerance of a novel topical composition in patients who had been successfully treated with topical or oral therapy for papulopustular rosacea but returned unsatisfied with their persistent erythema. Method: 25 subjects (23 women and 2 men) with papulopustular rosacea were enrolled in this 8 week multicenter, open-label study. 24 completed the study. All had been successfully treated for at least 6 weeks with at least one topical or oral rosacea medication but were unsatisfied due to persistent moderate-severe facial erythema. Subjects were asked to continue their previous rosacea medication and to commence twice daily application of the study lotion. Cleanser was provided for twice daily use before lotion application. Subjects were allowed to continue their normal sunscreen and cosmetic use. They were asked not to change or add skin care products during the course of the study. Clinician objective assessments of efficacy and tolerability and patient subjective assessments were conducted at baseline (before and after product application), and at weeks 4 and 8. Self assessment questionnaires were distributed after in-office product application at baseline and again at weeks 4 and 8. Clinician efficacy assessment included evaluation of persistent redness (erythema), flushing during the visit, skin texture, radiance, skin tone (evenness), overall rosacea severity and overall appearance on a 9 point scale (0-4 with ½ point increments). Clinician tolerability assessment included evaluation of dryness, edema, peeling and erythema on a 5 point scale (0-4). Patient subjective assessments of tolerability included stinging, burning, tingling and itching. Additionally, a self assessment questionnaire evaluated perceived improvement in erythematic and rosacea symptomatology, overall skin quality and satisfaction with the product. Digital photographs were captured on patients at baseline, week 4 week 8 for documentation purposes. Results: Results demonstrated that the facial product was well tolerated and significantly improved redness, flushing, overall papulopustular rosacea severity, skin texture, radiance, skin tone evenness, and overall appearance. Sponsored 100% by L’Oreal.
Methods: 50 subjects between the ages of 18 & 60 with mild to moderate acne were enrolled in this 12-wk study. Subjects using prescription acne medications for a minimum of 6 months were enrolled as long as they continue to use the acne medications for the duration of the study; had mild to moderate acne; & had oily &/or acne prone skin. Subjects were instructed to use the cleansing regimen whenever they cleansed their skin (morning &/or bedtime), not exceeding 2X/ day. Safety was assessed before & after 2 wks of product use via investigator assessments & measurements of Transepidermal Water Loss (TEWL), Erythema (E), & Hydration [(H) Corneometry]. Efficacy & long-term safety were evaluated through investigator assessments (global acne scale, 5 point ranking scale, 0 ¼ None & 4 ¼ Severe), & user perception. Results: Part I (safety): After 2 weeks of product use, TEWL measurements remained in the range for healthy skin (10-15 g/m2/h) & no significant change in E & H were measured (P ¼.77 & P ¼.28, respectively). Part II (efficacy & long-term safety): After 12 wks of product use, 92% of participants perceived the cleanser to be gentle on their skin for daily use, 80% felt their skin was hydrated after use, & 88% saw a reduction in the appearance of excess oil by at least 60%. Subjects additionally reported decreased frequency, duration & severity of their breakouts (89%, 88%, & 80%, respectively). Wilcoxon signed-rank test of the investigator acne assessment scores showed statistically significant improvement at 2 wks (average score of 1.8; P \ .001), 6 wks (average score of 1.42; P \.001), 12 wks (average score of 1.24; P \ .001) when compared to baseline (average score of 2.4).Conclusions: The acne cleansing regimen (sonic brush, acne brush head, & salicylic acid cleanser) is safe & effective for daily cleansing of acneic skin. Sponsored 100% by Pacific Bioscience Laboratories, Inc.
P8622 Improvement in atrophic acne scars by topical adapalene (0.3% gel) Manisha J. Patel, MD, John Hopkins University School of Medicine, Department of Dermatology, Baltimore, MD, United States; Anna L. Chien, MD, John Hopkins University School of Medicine, Department of Dermatology, Baltimore, MD, United States; Fabien Audibert, MMSc, Galderma R&D, SNC, Sophia Antipolis, France; Marie-Jos e Rueda, MD, Galderma R&D, SNC, La Defense, France; Nabil Kerrouche, MMSc, Galderma R&D, SNC, Sophia Antipolis, France; Sewon Kang, MD, Department of Dermatology, Johns Hopkins School of Medicine, Baltimore, MD, United States; Sherry Leung, RN, Johns Hopkins School of Medicine, Baltimore, MD, United States Background: Facial scarring is the most unfortunate and undesirable sequela of acne which can greatly impact quality of life. Current treatment modalities for atrophic acne scars are limited and require invasive procedures to improve appearance. Studies on wrinkles have shown that topical retinoids stimulate collagen production and increase epidermal thickness. Adapalene gel 0.3% e an effective agent for the treatment of acne e has been shown to reduce fine and coarse wrinkles and may potentially exert a beneficial effect in the treatment of atrophic acne scars. Objective: Investigate the efficacy of adapalene gel 0.3% in the treatment of atrophic acne scars. Methods: This open-label, pilot study involved 20 patients aged 18 to 50 years with moderate or severe facial atrophic acne scars. All patients received topical treatment with adapalene gel 0.3% once daily for the first 4 weeks and twice daily for the following 20 weeks. Assessment included global scarring grade, investigator (IGA) and patient global assessment (PGA) for improvement in skin texture and atrophic acne scars on the full face, atrophic acne scar counts on the skin surface area of interest (SSAOI) e a 3-by-3 cm area containing at least 5 acne scars e as well as local tolerability and Dermatology Life Quality Index (DLQI) questionnaire. Results: According to full-face global scarring grade at baseline, the majority of patients (60%) had moderate disease. At week 24, more than half of those (55.6%) achieved 1-grade or 2-grade change from baseline (38.9% and 16.7%, respectively). In addition, full-face IGA at week 24 showed at least marked improvement in skin texture and atrophic acne scars in 50% of patients. Similarly, PGA for skin texture and atrophic acne scars reported improvement in 83% and 89% of cases, respectively. In the SSAOI, patients had an average of 19 atrophic acne scars at baseline. Atrophic acne scar counts in the SSAOI at week 24 showed a 21.6% reduction from baseline. Moreover, DLQI at baseline and week 24 revealed improvement, with all patients experiencing little or no impairment on quality of life by the end of treatment (DLQI mean score: 4.3 versus 1.3, respectively). Treatment was well tolerated. Conclusions: Daily use of adapalene gel 0.3% for the treatment of atrophic acne scars showed promising efficacy and improvement in quality of life. Further clinical investigation is warranted to corroborate these findings. Supported by Galderma R&D, SNC. Poster/editorial support provided by Galderma Laboratories, L.P.
AB8
J AM ACAD DERMATOL
P8342 Minocycline weight-based dosing patterns and adverse event rates in patients with acne vulgaris Christina Cognata Smith, PharmD, MBA, Medicis Pharmaceutical Corporation, Scottsdale, AZ, United States; Mandeep Kaur, MD, MS, Medicis Pharmaceutical Corporation, Scottsdale, AZ, United States; Sham Chaudhari, MS, Xcenda, LLC, Palm Harbor, FL, United States; Thomas J. Bramley, PhD, Xcenda, LLC, Palm Harbor, FL, United States Background: Minocycline is a common treatment for patients with acne vulgaris, but it is associated with several adverse events. Appropriate weight-based dosing of minocycline may minimize the frequency of adverse events. The primary purpose of this study was to evaluate the relationship of average daily dose (ADD) and adverse events for 3 minocycline products. Methods: Patients aged 12e64 years with acne and treated with minocycline were identified from a large electronic medical record database between January 2007 and August 2012. Patients were required to be continuously eligible for follow-up 6 months prior to and 6 months following the date of the first prescription for minocycline (index date), have at least 1 ordered prescription for minocycline within the enrollment period, and have at least 1 recorded diagnosis of acne within 1 month of the pre- or post-index date. ADD was calculated for each patient based on strength, quantity supplied, days’ supply, and weight of patient. Patients with an ADD between 0.9 and 1.1 mg/kg per day were deemed to be within the target dosing range. In addition, 3 treatment groups were identified: minocycline IR (MIR), generic minocycline ER (MER), and branded MER. Branded MER was distinguished from generic MER, as there are more dosage strengths for branded MER than for generic MER. Logistic regression was used to model the association between ADD and several adverse events associated with minocycline (inflammatory bowel disease, headache, fatigue, dizziness, rash, and diarrhea). Results: There were 3,397 patients who qualified for study inclusion; 60 patients received generic MER, 3,029 patients received MIR, and 308 patients received branded MER. Overall, 10.8% of patients were within the target ADD range. Patients receiving branded MER (45.8%) were significantly more likely to be within the target ADD range than patients receiving MIR (7.2%) and generic MER (16.7%) (P\.0001). Patients within the target ADD range were significantly less for headache (OR ¼ 2.71; 95% CI: 1.17, 6.26) and fatigue (OR ¼ 1.81; 95% CI: 1.02, 3.20). Other investigated adverse events did not meet statistical significance. Conclusions: Minocycline dosed within the range of 0.9e1.1 mg/kg per day is associated with a lower incidence of headache and fatigue. Greater variability in dosage strengths seems to allow for better calibration of dosing based on patient weight. Supported by Medicis Pharmaceutical Corporation.
MAY 2014
P8383
Efficacy and tolerance of a novel topical composition on persistent redness observed in patients treated with topical or oral therapy for papulopustular rosacea Hilary Baldwin, Sunny Downstate Medical Center, New York, NY, United States; Christian Oresajo, L’Oreal Res. & Innovation, Clark, NJ, United States; Diane Berson, New York - Presbyterian/Well Cornell, New York, NY, United States; Margarita Yatskayer, L’Oreal Res. & Innovation, Clark, NJ, United States; Nannan Chen, L’Oreal Res. & Innovation, Clark, NJ, United States; Yevgeniy Krol, Skinceuticals Inc, New York, North Dakota, United States
Long-term efficacy and tolerance of a sonic brush and salicylic acid cleanser for cleansing acneic skin Katherine Ortblad, MHS, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Greg Peterson, PhD, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Robb Akridge, PhD, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Zoe Draelos, PA, MD, Dermatology Consulting Services, High Point, NC, United States Introduction: The delicate, compromised skin found with specific skin conditions presents cleansing challenges. Removal of dirt, oil, & bacteria without harming the function of the skin barrier are important when cleansing the skin. Objective: To evaluate the safety & efficacy of an acne cleansing regimen (sonic skin care brush, brush head designed for cleansing acneic skin, & 2% salicylic acid cleanser).
Purpose of study: Objective was to determine the efficacy and tolerance of a novel topical composition in patients who had been successfully treated with topical or oral therapy for papulopustular rosacea but returned unsatisfied with their persistent erythema. Method: 25 subjects (23 women and 2 men) with papulopustular rosacea were enrolled in this 8 week multicenter, open-label study. 24 completed the study. All had been successfully treated for at least 6 weeks with at least one topical or oral rosacea medication but were unsatisfied due to persistent moderate-severe facial erythema. Subjects were asked to continue their previous rosacea medication and to commence twice daily application of the study lotion. Cleanser was provided for twice daily use before lotion application. Subjects were allowed to continue their normal sunscreen and cosmetic use. They were asked not to change or add skin care products during the course of the study. Clinician objective assessments of efficacy and tolerability and patient subjective assessments were conducted at baseline (before and after product application), and at weeks 4 and 8. Self assessment questionnaires were distributed after in-office product application at baseline and again at weeks 4 and 8. Clinician efficacy assessment included evaluation of persistent redness (erythema), flushing during the visit, skin texture, radiance, skin tone (evenness), overall rosacea severity and overall appearance on a 9 point scale (0-4 with ½ point increments). Clinician tolerability assessment included evaluation of dryness, edema, peeling and erythema on a 5 point scale (0-4). Patient subjective assessments of tolerability included stinging, burning, tingling and itching. Additionally, a self assessment questionnaire evaluated perceived improvement in erythematic and rosacea symptomatology, overall skin quality and satisfaction with the product. Digital photographs were captured on patients at baseline, week 4 week 8 for documentation purposes. Results: Results demonstrated that the facial product was well tolerated and significantly improved redness, flushing, overall papulopustular rosacea severity, skin texture, radiance, skin tone evenness, and overall appearance. Sponsored 100% by L’Oreal.
Methods: 50 subjects between the ages of 18 & 60 with mild to moderate acne were enrolled in this 12-wk study. Subjects using prescription acne medications for a minimum of 6 months were enrolled as long as they continue to use the acne medications for the duration of the study; had mild to moderate acne; & had oily &/or acne prone skin. Subjects were instructed to use the cleansing regimen whenever they cleansed their skin (morning &/or bedtime), not exceeding 2X/ day. Safety was assessed before & after 2 wks of product use via investigator assessments & measurements of Transepidermal Water Loss (TEWL), Erythema (E), & Hydration [(H) Corneometry]. Efficacy & long-term safety were evaluated through investigator assessments (global acne scale, 5 point ranking scale, 0 ¼ None & 4 ¼ Severe), & user perception. Results: Part I (safety): After 2 weeks of product use, TEWL measurements remained in the range for healthy skin (10-15 g/m2/h) & no significant change in E & H were measured (P ¼.77 & P ¼.28, respectively). Part II (efficacy & long-term safety): After 12 wks of product use, 92% of participants perceived the cleanser to be gentle on their skin for daily use, 80% felt their skin was hydrated after use, & 88% saw a reduction in the appearance of excess oil by at least 60%. Subjects additionally reported decreased frequency, duration & severity of their breakouts (89%, 88%, & 80%, respectively). Wilcoxon signed-rank test of the investigator acne assessment scores showed statistically significant improvement at 2 wks (average score of 1.8; P \ .001), 6 wks (average score of 1.42; P \.001), 12 wks (average score of 1.24; P \ .001) when compared to baseline (average score of 2.4).Conclusions: The acne cleansing regimen (sonic brush, acne brush head, & salicylic acid cleanser) is safe & effective for daily cleansing of acneic skin. Sponsored 100% by Pacific Bioscience Laboratories, Inc.
P8622 Improvement in atrophic acne scars by topical adapalene (0.3% gel) Manisha J. Patel, MD, John Hopkins University School of Medicine, Department of Dermatology, Baltimore, MD, United States; Anna L. Chien, MD, John Hopkins University School of Medicine, Department of Dermatology, Baltimore, MD, United States; Fabien Audibert, MMSc, Galderma R&D, SNC, Sophia Antipolis, France; Marie-Jos e Rueda, MD, Galderma R&D, SNC, La Defense, France; Nabil Kerrouche, MMSc, Galderma R&D, SNC, Sophia Antipolis, France; Sewon Kang, MD, Department of Dermatology, Johns Hopkins School of Medicine, Baltimore, MD, United States; Sherry Leung, RN, Johns Hopkins School of Medicine, Baltimore, MD, United States Background: Facial scarring is the most unfortunate and undesirable sequela of acne which can greatly impact quality of life. Current treatment modalities for atrophic acne scars are limited and require invasive procedures to improve appearance. Studies on wrinkles have shown that topical retinoids stimulate collagen production and increase epidermal thickness. Adapalene gel 0.3% e an effective agent for the treatment of acne e has been shown to reduce fine and coarse wrinkles and may potentially exert a beneficial effect in the treatment of atrophic acne scars. Objective: Investigate the efficacy of adapalene gel 0.3% in the treatment of atrophic acne scars. Methods: This open-label, pilot study involved 20 patients aged 18 to 50 years with moderate or severe facial atrophic acne scars. All patients received topical treatment with adapalene gel 0.3% once daily for the first 4 weeks and twice daily for the following 20 weeks. Assessment included global scarring grade, investigator (IGA) and patient global assessment (PGA) for improvement in skin texture and atrophic acne scars on the full face, atrophic acne scar counts on the skin surface area of interest (SSAOI) e a 3-by-3 cm area containing at least 5 acne scars e as well as local tolerability and Dermatology Life Quality Index (DLQI) questionnaire. Results: According to full-face global scarring grade at baseline, the majority of patients (60%) had moderate disease. At week 24, more than half of those (55.6%) achieved 1-grade or 2-grade change from baseline (38.9% and 16.7%, respectively). In addition, full-face IGA at week 24 showed at least marked improvement in skin texture and atrophic acne scars in 50% of patients. Similarly, PGA for skin texture and atrophic acne scars reported improvement in 83% and 89% of cases, respectively. In the SSAOI, patients had an average of 19 atrophic acne scars at baseline. Atrophic acne scar counts in the SSAOI at week 24 showed a 21.6% reduction from baseline. Moreover, DLQI at baseline and week 24 revealed improvement, with all patients experiencing little or no impairment on quality of life by the end of treatment (DLQI mean score: 4.3 versus 1.3, respectively). Treatment was well tolerated. Conclusions: Daily use of adapalene gel 0.3% for the treatment of atrophic acne scars showed promising efficacy and improvement in quality of life. Further clinical investigation is warranted to corroborate these findings. Supported by Galderma R&D, SNC. Poster/editorial support provided by Galderma Laboratories, L.P.
AB8
J AM ACAD DERMATOL
P8342 Minocycline weight-based dosing patterns and adverse event rates in patients with acne vulgaris Christina Cognata Smith, PharmD, MBA, Medicis Pharmaceutical Corporation, Scottsdale, AZ, United States; Mandeep Kaur, MD, MS, Medicis Pharmaceutical Corporation, Scottsdale, AZ, United States; Sham Chaudhari, MS, Xcenda, LLC, Palm Harbor, FL, United States; Thomas J. Bramley, PhD, Xcenda, LLC, Palm Harbor, FL, United States Background: Minocycline is a common treatment for patients with acne vulgaris, but it is associated with several adverse events. Appropriate weight-based dosing of minocycline may minimize the frequency of adverse events. The primary purpose of this study was to evaluate the relationship of average daily dose (ADD) and adverse events for 3 minocycline products. Methods: Patients aged 12e64 years with acne and treated with minocycline were identified from a large electronic medical record database between January 2007 and August 2012. Patients were required to be continuously eligible for follow-up 6 months prior to and 6 months following the date of the first prescription for minocycline (index date), have at least 1 ordered prescription for minocycline within the enrollment period, and have at least 1 recorded diagnosis of acne within 1 month of the pre- or post-index date. ADD was calculated for each patient based on strength, quantity supplied, days’ supply, and weight of patient. Patients with an ADD between 0.9 and 1.1 mg/kg per day were deemed to be within the target dosing range. In addition, 3 treatment groups were identified: minocycline IR (MIR), generic minocycline ER (MER), and branded MER. Branded MER was distinguished from generic MER, as there are more dosage strengths for branded MER than for generic MER. Logistic regression was used to model the association between ADD and several adverse events associated with minocycline (inflammatory bowel disease, headache, fatigue, dizziness, rash, and diarrhea). Results: There were 3,397 patients who qualified for study inclusion; 60 patients received generic MER, 3,029 patients received MIR, and 308 patients received branded MER. Overall, 10.8% of patients were within the target ADD range. Patients receiving branded MER (45.8%) were significantly more likely to be within the target ADD range than patients receiving MIR (7.2%) and generic MER (16.7%) (P\.0001). Patients within the target ADD range were significantly less for headache (OR ¼ 2.71; 95% CI: 1.17, 6.26) and fatigue (OR ¼ 1.81; 95% CI: 1.02, 3.20). Other investigated adverse events did not meet statistical significance. Conclusions: Minocycline dosed within the range of 0.9e1.1 mg/kg per day is associated with a lower incidence of headache and fatigue. Greater variability in dosage strengths seems to allow for better calibration of dosing based on patient weight. Supported by Medicis Pharmaceutical Corporation.
MAY 2014