- Email: [email protected]
Single-center, open-label, efficacy and safety study of tazarotene for the treatment of brittle nails
P2105
P2107
The women’s hair growth questionnaire: Development and validation of a patient-reported measure for treatment efficacy in androgenetic alopecia Jane Harness, Pfizer Inc, New London, CT, United States; Carla Mamolo, PhD, Pfizer Inc, New London, CT, United States; Elise Olsen, MD, Department of Medicine/Dermatology, Durham, NC, United States; Vera Price, MD, School of Medicine/Department of Dermatology, San Francisco, CA, United States
Single-center, open-label, efficacy and safety study of tazarotene for the treatment of brittle nails Noelle Sherber, MD, Johns Hopkins Hospital, Department of Dermatology, Baltimore, MD, United States; Ariel Hoch, MPH, Columbia University, Department of Dermatology, New York, NY, United States; Carol Coppola, RN, Columbia University, Department of Dermatology, New York, NY, United States; Julian Mackay-Wiggan, MD, MS, Columbia University, Department of Dermatology, New York, NY, United States; Richard Scher, MD, University of NC, Department of Dermatology, Chapel Hill, NC, United States
Background: New drugs to promote hair growth need to demonstrate efficacy on two primary endpoints, one of which is patient self-assessment, for product efficacy to be approved by the US Food and Drug Administration (FDA). To date, no validated patient-reported outcome (PRO) measure developed specifically to assess the efficacy of treatments of female pattern hair loss/androgenetic alopecia (AGA) in women has been described in the literature. The purpose of this project was to develop and validate a measure of perceived hair growth, the Women’s Hair Growth Questionnaire (WHGQ), in accordance with FDA draft guidance for the use of PROs in clinical trials. Methods: Candidate questionnaire items were generated based on a literature review, patient input collected in multiple focus groups of women with a clinical diagnosis of AGA, and from consultation with expert clinicians. Twenty items were compiled into a draft questionnaire and face to face cognitive interviews were performed with women who demonstrated hair loss in order to assess the comprehension of each item. Patient feedback guided item revision and reduction until 6 items were judged to be clear and comprehensive of patients’ perceptions of hair growth and loss. These items were psychometrically evaluated in the context of a validation study of 151 women with AGA on treatment for their hair loss. The main purpose of the validation study was to perform item- and scale-level analyses (to inform any additional item reduction), and to determine the reliability and validity of the final questionnaire. Results: Based on the results from the validation study analyses, 4 of the 6 items were retained to form the WHGQ. These four items asked the patient to assess, since the start of the treatment: (1) growth of hair, (2) amount of noticeable new hair, (3) visibility of the scalp, and (4) rate of hair loss. The 4-item WHGQ showed acceptable internal consistency (Cronbach a ¼ 0.81) and strong testeretest reliability (ICC ¼ 0.89). The WHGQ was able to discriminate between patient- and physician-reported levels of improvement since the start of treatment. Conclusions: Based on extensive patient input and initial psychometric analyses, the 4-item WHGQ provides a valid patient self-assessment of hair growth, and shows promise as a primary efficacy endpoint for clinical trials evaluating new treatments for women with female pattern hair loss/AGA.
Objective: To determine whether topical tazarotene ameliorates signs and symptoms of brittle nails. Design: A single-center, open-label trial, with a 24-week treatment period and a 12-week follow-up period. Setting: Columbia University Medical Center, Department of Dermatology. Participants: Eighteen females and one male with brittle nails completed the study. Eligible patients needed to be between 18 and 76 years of age and to have evidence of brittle nails at screening. Intervention: Subjects applied tazarotene twice daily to all affected fingernails for 24 weeks. Main outcome measures: The change in the Physician’s Global Improvement Assessment of the two target nails at weeks 12 and 24. Results: Data from the 19 subjects who completed the study were included in the data analysis. One subject was excluded from the analysis of the primary endpoint, the Physician’s Global Improvement Assessment, because baseline photographs were not available. All 18 evaluable subjects achieved the primary endpoint of improvement in the Physician’s Global Improvement Assessment of the target nails at week 12, as did 16 out of 18 subjects at week 24. All 18 subjects had an improvement in Physician’s Global Improvement Assessment 12 weeks posttreatment at week 36. The secondary endpoint, Physician’s Global Assessment, improved for 14 of the 19 subjects (73.7%) at both weeks 12 and 24. At week 36, 17 out of 19 subjects (89.5%) agreed that their nails had improved overall. One subject (5.3%) reported mild local irritation. Conclusions: Tazarotene improves some signs and symptoms of brittle nails with minimal to no irritation. Commercial support: Sponsored by a grant provided by Allergan.
Commercial support: 100% sponsored by Pfizer Inc.
P2106 Study of cardiovascular risk factors in patients with androgenetic alopecia: Metabolic syndrome and carotid atheromatosis Salvador Arias-Santiago, MD, San Cecilio Clinical Hospital, Granada, Spain; Luisa Castellote-Caballero, MD, San Cecilio Clinical Hospital, Granada, Spain; Maria Teresa Gutierrez Salmeron, MD, San Cecilio Clinical Hospital, Granada, Spain; ´ n Naranjo-Sintes, MD, San Cecilio Clinical Hospital, Granada, Spain Ramo Introduction: The link between androgenetic alopecia (AGA) and cardiovascular disease has been studied by several authors in recent decades, with different results in the epidemiologic studies carried out. The purpose of this paper is to determine the prevalence of metabolic syndrome and the degree of carotid arteriosclerosis in patients with early-onset AGA (before the age of 35) treated at our hospital, and make a comparison with a control group of dermatology patients without AGA.
P2108 Semiautomatic handheld videotrichogram Jung Won Shin, Seoul, South Korea; Chang Hun Huh, MD, PhD, Seoul, South Korea; Hee Chul Eun, MD, PhD, Seoul, South Korea; Kyoung Chan Park, MD, PhD, Seoul, South Korea; Sang Woong Youn, MD, PhD, Seoul, South Korea Introduction: For many years, phototrichogram has been a standard and essential tool for hair research. But because of its complexity to perform, phototrichogram is used only in clinical research area rather than practically used. Recently, technological development makes a big advancement in digitalizing system. Semiautomatic handheld videotrichogram is one of the advanced technologies in hair research field. It has a CCD with digitalized ruler, which makes a precise measurement of certain object like hairs. The purpose of this study is to compare semiautomatic handheld videotrichogram and conventional phototrichogram, and probe the effectiveness of videotrichogram.
Methods: Thirty patients (21 males and 9 females) diagnosed with early-onset AGA by the Dermatology Unit at San Cecilio Hospital between November 2007 and May 2008, plus a control group of another 30 patients, divided identically by sex, who were being treated for other pathologies. In both groups the criteria for metabolic syndrome proposed by the ATP-III (obesity, triglyceridemia, HDL-C, blood pressure, and glycemia), and the presence of carotid atheromatous plaque measured by Doppler ultrasound. Other cardiovascular risk factors and hormone studies were also considered. Results: Fifty percent of the AGA patients met metabolic syndrome criteria, compared with 13% in the control group (P \ .05). Of the AGA patients, nine presented with atheromatous plaques, four of them in both carotids, and in two cases the blood flow was affected. In the control group, unilateral carotid plaque was found in two patients (P\.05), without the blood flow being affected. The body mass index) was similar in the two groups (mean value of 27.3 for the control group and 28 for the AGA patients); however, abdominal obesity and hypertriglyceridemia, analyzed separately, reached significantly higher values in the alopecia group. Testosterone levels were similar in the two groups, although sex hormoneebinding globulin was higher in the control group, without being statistically significant. However, insulin and aldosterone levels were higher in the AGA group (P \.05).
Results: It is well correlated within each subject between two methods in terms of all measured parameter including hair density, diameter, and growth rate. But we found some discrepancies between two methods: (1) density measured by semiautomatic handheld videotrichogram shows less (100.0 6 12.3 vs 90.6 6 14.5; P ¼.001) and (2) diameters are thicker (44.1 6 8.0 vs 46.6 6 9.7; P ¼ .005). We think that hair count discrepancy is caused by automatization errors of conventional phototrichogram and measured diameters are differs because of the magnification power. Moreover, there’s another merits using semiautomatic handheld videotrichogram, which is no clipping or dyeing is required for the density or diameter analysis.
Conclusions: The high frequency with which metabolic syndrome and carotid atheromatosis are found in patients with AGA makes it appropriate for this group to be screened with a view to the early detection of individuals at risk, in order that preventive treatment may begin before cardiovascular disease sets in.
Conclusions: We can conclude that semiautomatic handheld videotrichogram can be one of the useful techniques for the hair research. We think its ease of use can make phototrichogram more popular in clinical practice and not only in the research field.
Commercial support: None identified.
Commercial support: None identified.
AB100
J AM ACAD DERMATOL
Methods: Thirteen volunteers with androgenetic alopecia were involved. Measuring points were 15 cm above glabella of the subjects and marked with a tattoo after shaving to ensure reproducibility. Both conventional phototrichogram and semiautomatic handheld videotrichogram were applied at baseline and 2 days later to measure and compare hair density, linear hair growth rate, and hair thickness.
MARCH 2009
P2107
The women’s hair growth questionnaire: Development and validation of a patient-reported measure for treatment efficacy in androgenetic alopecia Jane Harness, Pfizer Inc, New London, CT, United States; Carla Mamolo, PhD, Pfizer Inc, New London, CT, United States; Elise Olsen, MD, Department of Medicine/Dermatology, Durham, NC, United States; Vera Price, MD, School of Medicine/Department of Dermatology, San Francisco, CA, United States
Single-center, open-label, efficacy and safety study of tazarotene for the treatment of brittle nails Noelle Sherber, MD, Johns Hopkins Hospital, Department of Dermatology, Baltimore, MD, United States; Ariel Hoch, MPH, Columbia University, Department of Dermatology, New York, NY, United States; Carol Coppola, RN, Columbia University, Department of Dermatology, New York, NY, United States; Julian Mackay-Wiggan, MD, MS, Columbia University, Department of Dermatology, New York, NY, United States; Richard Scher, MD, University of NC, Department of Dermatology, Chapel Hill, NC, United States
Background: New drugs to promote hair growth need to demonstrate efficacy on two primary endpoints, one of which is patient self-assessment, for product efficacy to be approved by the US Food and Drug Administration (FDA). To date, no validated patient-reported outcome (PRO) measure developed specifically to assess the efficacy of treatments of female pattern hair loss/androgenetic alopecia (AGA) in women has been described in the literature. The purpose of this project was to develop and validate a measure of perceived hair growth, the Women’s Hair Growth Questionnaire (WHGQ), in accordance with FDA draft guidance for the use of PROs in clinical trials. Methods: Candidate questionnaire items were generated based on a literature review, patient input collected in multiple focus groups of women with a clinical diagnosis of AGA, and from consultation with expert clinicians. Twenty items were compiled into a draft questionnaire and face to face cognitive interviews were performed with women who demonstrated hair loss in order to assess the comprehension of each item. Patient feedback guided item revision and reduction until 6 items were judged to be clear and comprehensive of patients’ perceptions of hair growth and loss. These items were psychometrically evaluated in the context of a validation study of 151 women with AGA on treatment for their hair loss. The main purpose of the validation study was to perform item- and scale-level analyses (to inform any additional item reduction), and to determine the reliability and validity of the final questionnaire. Results: Based on the results from the validation study analyses, 4 of the 6 items were retained to form the WHGQ. These four items asked the patient to assess, since the start of the treatment: (1) growth of hair, (2) amount of noticeable new hair, (3) visibility of the scalp, and (4) rate of hair loss. The 4-item WHGQ showed acceptable internal consistency (Cronbach a ¼ 0.81) and strong testeretest reliability (ICC ¼ 0.89). The WHGQ was able to discriminate between patient- and physician-reported levels of improvement since the start of treatment. Conclusions: Based on extensive patient input and initial psychometric analyses, the 4-item WHGQ provides a valid patient self-assessment of hair growth, and shows promise as a primary efficacy endpoint for clinical trials evaluating new treatments for women with female pattern hair loss/AGA.
Objective: To determine whether topical tazarotene ameliorates signs and symptoms of brittle nails. Design: A single-center, open-label trial, with a 24-week treatment period and a 12-week follow-up period. Setting: Columbia University Medical Center, Department of Dermatology. Participants: Eighteen females and one male with brittle nails completed the study. Eligible patients needed to be between 18 and 76 years of age and to have evidence of brittle nails at screening. Intervention: Subjects applied tazarotene twice daily to all affected fingernails for 24 weeks. Main outcome measures: The change in the Physician’s Global Improvement Assessment of the two target nails at weeks 12 and 24. Results: Data from the 19 subjects who completed the study were included in the data analysis. One subject was excluded from the analysis of the primary endpoint, the Physician’s Global Improvement Assessment, because baseline photographs were not available. All 18 evaluable subjects achieved the primary endpoint of improvement in the Physician’s Global Improvement Assessment of the target nails at week 12, as did 16 out of 18 subjects at week 24. All 18 subjects had an improvement in Physician’s Global Improvement Assessment 12 weeks posttreatment at week 36. The secondary endpoint, Physician’s Global Assessment, improved for 14 of the 19 subjects (73.7%) at both weeks 12 and 24. At week 36, 17 out of 19 subjects (89.5%) agreed that their nails had improved overall. One subject (5.3%) reported mild local irritation. Conclusions: Tazarotene improves some signs and symptoms of brittle nails with minimal to no irritation. Commercial support: Sponsored by a grant provided by Allergan.
Commercial support: 100% sponsored by Pfizer Inc.
P2106 Study of cardiovascular risk factors in patients with androgenetic alopecia: Metabolic syndrome and carotid atheromatosis Salvador Arias-Santiago, MD, San Cecilio Clinical Hospital, Granada, Spain; Luisa Castellote-Caballero, MD, San Cecilio Clinical Hospital, Granada, Spain; Maria Teresa Gutierrez Salmeron, MD, San Cecilio Clinical Hospital, Granada, Spain; ´ n Naranjo-Sintes, MD, San Cecilio Clinical Hospital, Granada, Spain Ramo Introduction: The link between androgenetic alopecia (AGA) and cardiovascular disease has been studied by several authors in recent decades, with different results in the epidemiologic studies carried out. The purpose of this paper is to determine the prevalence of metabolic syndrome and the degree of carotid arteriosclerosis in patients with early-onset AGA (before the age of 35) treated at our hospital, and make a comparison with a control group of dermatology patients without AGA.
P2108 Semiautomatic handheld videotrichogram Jung Won Shin, Seoul, South Korea; Chang Hun Huh, MD, PhD, Seoul, South Korea; Hee Chul Eun, MD, PhD, Seoul, South Korea; Kyoung Chan Park, MD, PhD, Seoul, South Korea; Sang Woong Youn, MD, PhD, Seoul, South Korea Introduction: For many years, phototrichogram has been a standard and essential tool for hair research. But because of its complexity to perform, phototrichogram is used only in clinical research area rather than practically used. Recently, technological development makes a big advancement in digitalizing system. Semiautomatic handheld videotrichogram is one of the advanced technologies in hair research field. It has a CCD with digitalized ruler, which makes a precise measurement of certain object like hairs. The purpose of this study is to compare semiautomatic handheld videotrichogram and conventional phototrichogram, and probe the effectiveness of videotrichogram.
Methods: Thirty patients (21 males and 9 females) diagnosed with early-onset AGA by the Dermatology Unit at San Cecilio Hospital between November 2007 and May 2008, plus a control group of another 30 patients, divided identically by sex, who were being treated for other pathologies. In both groups the criteria for metabolic syndrome proposed by the ATP-III (obesity, triglyceridemia, HDL-C, blood pressure, and glycemia), and the presence of carotid atheromatous plaque measured by Doppler ultrasound. Other cardiovascular risk factors and hormone studies were also considered. Results: Fifty percent of the AGA patients met metabolic syndrome criteria, compared with 13% in the control group (P \ .05). Of the AGA patients, nine presented with atheromatous plaques, four of them in both carotids, and in two cases the blood flow was affected. In the control group, unilateral carotid plaque was found in two patients (P\.05), without the blood flow being affected. The body mass index) was similar in the two groups (mean value of 27.3 for the control group and 28 for the AGA patients); however, abdominal obesity and hypertriglyceridemia, analyzed separately, reached significantly higher values in the alopecia group. Testosterone levels were similar in the two groups, although sex hormoneebinding globulin was higher in the control group, without being statistically significant. However, insulin and aldosterone levels were higher in the AGA group (P \.05).
Results: It is well correlated within each subject between two methods in terms of all measured parameter including hair density, diameter, and growth rate. But we found some discrepancies between two methods: (1) density measured by semiautomatic handheld videotrichogram shows less (100.0 6 12.3 vs 90.6 6 14.5; P ¼.001) and (2) diameters are thicker (44.1 6 8.0 vs 46.6 6 9.7; P ¼ .005). We think that hair count discrepancy is caused by automatization errors of conventional phototrichogram and measured diameters are differs because of the magnification power. Moreover, there’s another merits using semiautomatic handheld videotrichogram, which is no clipping or dyeing is required for the density or diameter analysis.
Conclusions: The high frequency with which metabolic syndrome and carotid atheromatosis are found in patients with AGA makes it appropriate for this group to be screened with a view to the early detection of individuals at risk, in order that preventive treatment may begin before cardiovascular disease sets in.
Conclusions: We can conclude that semiautomatic handheld videotrichogram can be one of the useful techniques for the hair research. We think its ease of use can make phototrichogram more popular in clinical practice and not only in the research field.
Commercial support: None identified.
Commercial support: None identified.
AB100
J AM ACAD DERMATOL
Methods: Thirteen volunteers with androgenetic alopecia were involved. Measuring points were 15 cm above glabella of the subjects and marked with a tattoo after shaving to ensure reproducibility. Both conventional phototrichogram and semiautomatic handheld videotrichogram were applied at baseline and 2 days later to measure and compare hair density, linear hair growth rate, and hair thickness.
MARCH 2009