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Evaluation of a sonic skin care brush on the reduction of shaving-induced irritation
P119
P121
An open-label, community-based, phase IV study to assess facial acne improvement with the use of tretinoin gel microsphere in a pump dispenser Lawrence Eichenfield, MD, San Diego, CA, United States; Marge Nighland, MS, Johnson & Johnson, Skillman, NJ, United States; The PUMP Study Research Group, MD, PUMP Study Investigators, Skillman, NJ, United States Acne vulgaris is a follicular disorder occurring in specialized pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface, carrying along with it desquamated cells from follicular epithelium. Acne develops when these specialized follicles undergo pathologic alterations that result in the formation of noninflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules). Reported here are the efficacy findings of this open-label, nonrandomized, multicenter, community-based phase IV study of acne patients who at study entry are dissatisfied with their current acne treatment. Qualified patients received either tretinoin gel microsphere (TGM) 0.04% or 0.01% in a pump dispenser. The primary objective was to assess the degree of improvement of facial acne vulgaris following a treatment with TGM in a pump dispenser for 12 weeks. In addition, at the investigator’s discretion, patients could be treated with up to 2 other concurrent acne therapies. Additional concurrent therapies could not include another retinoid. If two additional concurrent therapies were used during the treatment period, only one of these additional treatments could be a topical therapy (eg, a topical concurrent therapy and an oral concurrent therapy are acceptable). Efficacy parameters included assessment of the Modified Global Acne Grade (mGAGS) score from baseline to week 12 and in the Investigator’s Global Evaluation (IGE) of treatment response at week 12. A total of 537 subjects (male or female, ages 12 yrs and older) were enrolled: 358 received the TGM 0.04% pump and 179 received the TGM 0.1% pump. After 12 weeks of treatment, a significant improvement was shown in both the mGAGS and the IGE (P \.0001, week 1 vs. week 12 of either 0.04% or 0.1%). Moderate, marked, cleared, or almost cleared improvement was noted in more than 65% of subjects (P \.0001). The majority of side effects were characteristic following the use of topical retinoids and did not affect subject compliance. We conclude that TGM in a pump dispenser is an effective, robust treatment for acne vulgaris in subjects 12 years of age and older.
Acne quality of life and patient satisfaction following treatment with tretinoin gel microsphere in a pump dispenser Richard Fried, MD, PhD, Yardley Dermatology Associates, Yardley, PA, United States; Marge Nighland, MS, Johnson & Johnson, Skillman, NJ, United States; The PUMP Study Research Group, MD, Johnson & Johnson, Skillman, NJ, United States
Support provided by OrthoNeutrogena, a member of the Johnson & Johnson Group of Consumer Companies.
Support provided by OrthoNeutrogena, a member of the Johnson & Johnson Group of Consumer Companies.
P122
P120 Evaluation of a sonic skin care brush on the reduction of shaving-induced irritation Katherine Ortblad, MPA, Pacific Bioscience Laboratories, Bellevue, WA, United States; Emily Henes, Pacific Bioscience Laboratories, Bellevue, WA, United States; Gregory Peterson, PhD, Pacific Bioscience Laboratories, Bellevue, WA, United States; Robert Akridge, PhD, Pacific Bioscience Laboratories, Bellevue, WA, United States Pseudofolliculitis barbae (PFB), or razor bumps, is an inflammatory condition characterized by red, itchy skin with papules or pustules similar in appearance to acne. PFB is most prevalent on the face of men of African descent or men with curly hair, occurring in up to 60% to 80% of men of African descent who shave regularly. PFB occurs with close shaving; closely cut hairs curl back into the skin, resulting in inflammation. Treatment options for PFB are varied and include, but are not limited to, topical treatments (eg, retinoids, glycolic acid, and benzoyl peroxide); reduced shaving frequency (or no shaving); chemical depilatory agents; reduced shaving closeness (eg, use of single-blade or electric razors); and exfoliation and modified shaving techniques. In this study, we evaluate a shaving routine that includes the use of a sonic skin care brush on the reduction of razor bumps and irritation associated with shaving. Men between the ages of 18 and 60 years who exclusively use manual razors for wet shaving were enrolled in this study. Subjects were instructed to apply shaving lubricant with the sonic skin care brush for 40 seconds before shaving. Subjects did not otherwise change their shaving routine. Photographic image analysis and subject assessments following 2 and 8 weeks of use were used to evaluate the condition of the skin and severity of razor bumps over the course of the study, with favorable outcomes. Subjects reported a reduction in razor bumps (77%) and irritation. Subject assessment, image analysis, and photographic results will be presented. 100% supported by Pacific Bioscience Laboratories, Inc.
AB16
Patient satisfaction and quality of life are important aspects to assess when utilizing various treatment modalities for the management of acne vulgaris. Patient compliance with treatments that are associated with a high degree of adverse effects or are complicated to use can be very low. In addition, the use of a product that is hard to measure or apply can also negatively affect not only treatment outcomes, but also the overall effectivness of the product. During a community assessment trial of more than 500 subjects (age 12 years and older), an assessment of patient improvement in Acne Quality of Life Index (Acne-QOLI) and an assessment of patient’s satisfaction was conducted. The Acne-QOLI consists of 21 questions, each rated on a 7-point scale. Three subscales (7 questions each) represent the social, psychological, and mood aspects of the instrument. The subscale mean was used to summarize each subscale score, and the average over subscales defined the total score. A 1-sample t test was used to evaluate changes in Acne-QOLI and VAS satisfaction scores. All subjects were previously dissatisfied with their current treatment and agreed to receive either 0.04% or 0.1% tretinoin gel microsphere in a pump dispenser (TGMP) for 12 weeks. Patients completed the Acne-QOLI questionnaire and with the aid of a VAS at baseline and at week 12 of treatment. In addition, at the investigator’s discretion, patients could be treated with up to 2 other concurrent acne therapies. Additional concurrent therapies could not include another retinoid. If two additional concurrent therapies were used during the treatment period, only one of these additional treatments could be a topical therapy (eg, a topical concurrent therapy and an oral concurrent therapy are acceptable). A total of 537 were enrolled in the 12-week study. Approximately 30% of participants were male (70% female) and the average age was 22 years. The majority of subjects were white, African American, and Hispanic (total of all groups, 95.8%). Regardless of the strength of TGMP, subjects reported a significant increase in their quality of life (P \.0001) following 12 weeks of treatment. In addition, subjects noted a significant increase in their satisfaction with their acne treatment (P \.0001). We conclude that the use of TGMP in patients with acne vulgaris is associated with significant increases in both quality of life and patient satisfaction.
J AM ACAD DERMATOL
Methylaminolevulinate-photodynamic therapy for treatment of inflamatory acne vulgaris—Brazilian experience Macedo Otavio, MD, Consultorio Clinico Dr. Otavio R. Macedo, S~ao Paulo, Brazil; Cristine Wippel, MD, Consultorio Clinico Dr. Otavio R. Macedo, S~ao Paulo, Brazil; Adriana Salgado, Consultorio Clinico Dr. Otavio R. Macedo, S~ao Paulo, Brazil; Marisa Fugimura, MD, Consultorio Clinico Dr. Otavio R. Macedo, S~ao Paulo, Brazil Background: Inflamatory acne vulgaris is a common dermatosis affecting the pilosebaceous units. The predominant organism in the follicular flora is Propionibacterium acnes, which is known to produce intracellular porphyrins. Objective: Methylaminolevulinate (MAL) and blue light destroys P acnes by targeting the porphyrins. Reactive oxygen species, generated by excited porphyrin molecules, can destroy P acnes. MAL-photodynamic therapy is emerging as an alternative option to treat acne vulgaris with a marked effect on inflammatory lesions. Methods: Ten patients with mild to moderate inflammatory acne vulgaris were treated with one session of thick layer topical MAL cream on the whole face for 30 minutes with occlusive dressing, followed by washing and blue light exposure. Porphyrin fluorescence photographs were taken with a Canfield Visia CR System before the first session and at follow-up visits. Inflammatory and noninflammatory acne elements were counted and the bacterial fluorescence emission was measured. Results: All patients reported burning, erythema, edema, crusting, and pustular eruptions, which mostly resolved within 1 week. Four weeks after the treatment, we found a reduction from inflammatory and noninflammatory lesions and also the fluorescence related to P acnes. Conclusions: Short MAL incubation time and blue light proved to be an efficient treatment for inflammatory acne. Commercial support: None identified.
FEBRUARY 2008
P121
An open-label, community-based, phase IV study to assess facial acne improvement with the use of tretinoin gel microsphere in a pump dispenser Lawrence Eichenfield, MD, San Diego, CA, United States; Marge Nighland, MS, Johnson & Johnson, Skillman, NJ, United States; The PUMP Study Research Group, MD, PUMP Study Investigators, Skillman, NJ, United States Acne vulgaris is a follicular disorder occurring in specialized pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface, carrying along with it desquamated cells from follicular epithelium. Acne develops when these specialized follicles undergo pathologic alterations that result in the formation of noninflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules). Reported here are the efficacy findings of this open-label, nonrandomized, multicenter, community-based phase IV study of acne patients who at study entry are dissatisfied with their current acne treatment. Qualified patients received either tretinoin gel microsphere (TGM) 0.04% or 0.01% in a pump dispenser. The primary objective was to assess the degree of improvement of facial acne vulgaris following a treatment with TGM in a pump dispenser for 12 weeks. In addition, at the investigator’s discretion, patients could be treated with up to 2 other concurrent acne therapies. Additional concurrent therapies could not include another retinoid. If two additional concurrent therapies were used during the treatment period, only one of these additional treatments could be a topical therapy (eg, a topical concurrent therapy and an oral concurrent therapy are acceptable). Efficacy parameters included assessment of the Modified Global Acne Grade (mGAGS) score from baseline to week 12 and in the Investigator’s Global Evaluation (IGE) of treatment response at week 12. A total of 537 subjects (male or female, ages 12 yrs and older) were enrolled: 358 received the TGM 0.04% pump and 179 received the TGM 0.1% pump. After 12 weeks of treatment, a significant improvement was shown in both the mGAGS and the IGE (P \.0001, week 1 vs. week 12 of either 0.04% or 0.1%). Moderate, marked, cleared, or almost cleared improvement was noted in more than 65% of subjects (P \.0001). The majority of side effects were characteristic following the use of topical retinoids and did not affect subject compliance. We conclude that TGM in a pump dispenser is an effective, robust treatment for acne vulgaris in subjects 12 years of age and older.
Acne quality of life and patient satisfaction following treatment with tretinoin gel microsphere in a pump dispenser Richard Fried, MD, PhD, Yardley Dermatology Associates, Yardley, PA, United States; Marge Nighland, MS, Johnson & Johnson, Skillman, NJ, United States; The PUMP Study Research Group, MD, Johnson & Johnson, Skillman, NJ, United States
Support provided by OrthoNeutrogena, a member of the Johnson & Johnson Group of Consumer Companies.
Support provided by OrthoNeutrogena, a member of the Johnson & Johnson Group of Consumer Companies.
P122
P120 Evaluation of a sonic skin care brush on the reduction of shaving-induced irritation Katherine Ortblad, MPA, Pacific Bioscience Laboratories, Bellevue, WA, United States; Emily Henes, Pacific Bioscience Laboratories, Bellevue, WA, United States; Gregory Peterson, PhD, Pacific Bioscience Laboratories, Bellevue, WA, United States; Robert Akridge, PhD, Pacific Bioscience Laboratories, Bellevue, WA, United States Pseudofolliculitis barbae (PFB), or razor bumps, is an inflammatory condition characterized by red, itchy skin with papules or pustules similar in appearance to acne. PFB is most prevalent on the face of men of African descent or men with curly hair, occurring in up to 60% to 80% of men of African descent who shave regularly. PFB occurs with close shaving; closely cut hairs curl back into the skin, resulting in inflammation. Treatment options for PFB are varied and include, but are not limited to, topical treatments (eg, retinoids, glycolic acid, and benzoyl peroxide); reduced shaving frequency (or no shaving); chemical depilatory agents; reduced shaving closeness (eg, use of single-blade or electric razors); and exfoliation and modified shaving techniques. In this study, we evaluate a shaving routine that includes the use of a sonic skin care brush on the reduction of razor bumps and irritation associated with shaving. Men between the ages of 18 and 60 years who exclusively use manual razors for wet shaving were enrolled in this study. Subjects were instructed to apply shaving lubricant with the sonic skin care brush for 40 seconds before shaving. Subjects did not otherwise change their shaving routine. Photographic image analysis and subject assessments following 2 and 8 weeks of use were used to evaluate the condition of the skin and severity of razor bumps over the course of the study, with favorable outcomes. Subjects reported a reduction in razor bumps (77%) and irritation. Subject assessment, image analysis, and photographic results will be presented. 100% supported by Pacific Bioscience Laboratories, Inc.
AB16
Patient satisfaction and quality of life are important aspects to assess when utilizing various treatment modalities for the management of acne vulgaris. Patient compliance with treatments that are associated with a high degree of adverse effects or are complicated to use can be very low. In addition, the use of a product that is hard to measure or apply can also negatively affect not only treatment outcomes, but also the overall effectivness of the product. During a community assessment trial of more than 500 subjects (age 12 years and older), an assessment of patient improvement in Acne Quality of Life Index (Acne-QOLI) and an assessment of patient’s satisfaction was conducted. The Acne-QOLI consists of 21 questions, each rated on a 7-point scale. Three subscales (7 questions each) represent the social, psychological, and mood aspects of the instrument. The subscale mean was used to summarize each subscale score, and the average over subscales defined the total score. A 1-sample t test was used to evaluate changes in Acne-QOLI and VAS satisfaction scores. All subjects were previously dissatisfied with their current treatment and agreed to receive either 0.04% or 0.1% tretinoin gel microsphere in a pump dispenser (TGMP) for 12 weeks. Patients completed the Acne-QOLI questionnaire and with the aid of a VAS at baseline and at week 12 of treatment. In addition, at the investigator’s discretion, patients could be treated with up to 2 other concurrent acne therapies. Additional concurrent therapies could not include another retinoid. If two additional concurrent therapies were used during the treatment period, only one of these additional treatments could be a topical therapy (eg, a topical concurrent therapy and an oral concurrent therapy are acceptable). A total of 537 were enrolled in the 12-week study. Approximately 30% of participants were male (70% female) and the average age was 22 years. The majority of subjects were white, African American, and Hispanic (total of all groups, 95.8%). Regardless of the strength of TGMP, subjects reported a significant increase in their quality of life (P \.0001) following 12 weeks of treatment. In addition, subjects noted a significant increase in their satisfaction with their acne treatment (P \.0001). We conclude that the use of TGMP in patients with acne vulgaris is associated with significant increases in both quality of life and patient satisfaction.
J AM ACAD DERMATOL
Methylaminolevulinate-photodynamic therapy for treatment of inflamatory acne vulgaris—Brazilian experience Macedo Otavio, MD, Consultorio Clinico Dr. Otavio R. Macedo, S~ao Paulo, Brazil; Cristine Wippel, MD, Consultorio Clinico Dr. Otavio R. Macedo, S~ao Paulo, Brazil; Adriana Salgado, Consultorio Clinico Dr. Otavio R. Macedo, S~ao Paulo, Brazil; Marisa Fugimura, MD, Consultorio Clinico Dr. Otavio R. Macedo, S~ao Paulo, Brazil Background: Inflamatory acne vulgaris is a common dermatosis affecting the pilosebaceous units. The predominant organism in the follicular flora is Propionibacterium acnes, which is known to produce intracellular porphyrins. Objective: Methylaminolevulinate (MAL) and blue light destroys P acnes by targeting the porphyrins. Reactive oxygen species, generated by excited porphyrin molecules, can destroy P acnes. MAL-photodynamic therapy is emerging as an alternative option to treat acne vulgaris with a marked effect on inflammatory lesions. Methods: Ten patients with mild to moderate inflammatory acne vulgaris were treated with one session of thick layer topical MAL cream on the whole face for 30 minutes with occlusive dressing, followed by washing and blue light exposure. Porphyrin fluorescence photographs were taken with a Canfield Visia CR System before the first session and at follow-up visits. Inflammatory and noninflammatory acne elements were counted and the bacterial fluorescence emission was measured. Results: All patients reported burning, erythema, edema, crusting, and pustular eruptions, which mostly resolved within 1 week. Four weeks after the treatment, we found a reduction from inflammatory and noninflammatory lesions and also the fluorescence related to P acnes. Conclusions: Short MAL incubation time and blue light proved to be an efficient treatment for inflammatory acne. Commercial support: None identified.
FEBRUARY 2008