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A single-blinded, randomized, controlled, clinical trial evaluating the effect of face washing on acne vulgaris
P106
P108
A QUALITATIVE AND QUANTITATIVE ASSESSMENT OF THE APPLICATION AND CONSUMPTION OF TOPICAL ACNE MEDICATION BY PATIENTS James Del Rosso, DO, University of Nevada School of Medicine, Las Vegas, NV, United States
A TWO-CENTER PATIENT PREFERENCE STUDY COMPARING TWO ACNE GELS Emil Tanghetti, MD, Center for Dermatology and Laser Surgery, Sacramento, CA, United States; Michael Gold, MD, Tennessee Clinical Research Center, Inc., Nashville, TN, United States; Joanne Fraser, PhD, A. C. Stiefel Research Institute, Inc., Oak Hill, NY, United States A new, topical acne gel containing 1% clindamycin and 5% benzoyl peroxide in a ready-to-dispense formulation was compared to another topical acne gel also containing 1% clindamycin and 5% benzoyl peroxide for local tolerance and efficacy. The new gel is indicated for once-daily treatment of inflammatory acne and is available in a tube. The other gel product is indicated for the twice-daily treatment of acne vulgaris, must be mixed in the pharmacy before dispensing, and comes in a jar. Both products are stored at room temperature after dispensing to the patient.
Management of acne requires proper application and compliance with medication use. In this trial, careful documentation of topical medication consumption and methods of application are completed, with photographic methods used to determining area of medication coverage. Data are collected from study periods both before and after the use of a designated patient instruction program. The poster discusses the implications of vehicle type, application methodologies, and patient education on compliance, efficacy, longevity of use of a fixed amount of product and cost. Stiefel, Galderma, Medicis, Dermik, Healthpoint, Allergan. 100% sponsored by Stiefel
This study explored factors that are influential in determining patient preference in acne medication selection. The study was a crossover design in which subjects with mild to moderate acne vulgaris were assigned to 2 weeks of treatment with each medication randomized to either the first or second period. Treatment periods were separated by a 2-week washout period. Use of topical moisturizers on the face was prohibited during the study. A clinical assessment including inflammatory lesion count, noninflammatory lesion count, peeling, erythema, and dryness was performed at baseline and week 2 of each study period by a blinded evaluator. Subjects completed questionnaires concerning packaging acceptability and safety and efficacy after 2 weeks of treatment. At the end of the study, subjects completed a preference questionnaire concerning safety, efficacy, dosing regimen, and packaging. Dr. Fraser is an employee of the manufacturer. 100% sponsored by Stiefel Laboratories, Inc.
P107 A SINGLE-BLINDED, RANDOMIZED, CONTROLLED, CLINICAL TRIAL EVALUATING THE EFFECT OF FACE WASHING ON ACNE VULGARIS Alexa Kimball, MD, MPH, Joanna Mimi Choi, BS, Vincent Lew, BS, Stanford University, Stanford, CA, United States The relationship between face washing and acne vulgaris is a confusing one. While the general public associates poor hygiene with bad acne, dermatologists also caution that too much face washing can exacerbate the condition. Moreover, the recommendation to wash the face twice daily with a mild cleanser has little supporting evidence. Consequently, we conducted a single-blinded, randomized, controlled, clinical trial to evaluate the effect of face washing on acne vulgaris. Male subjects with mild to moderate acne were recruited for our study and allowed to continue any ongoing acne treatments, except for medicated face wash (n = 34). After an initial 2-week wash-in period of washing the face twice daily with the same mild cleanser, participants were randomized into 3 study groups (n = 9,9,9) and washed their faces once, twice, or four times daily for a 6-week study period. A trained and blinded evaluator graded subjects’ acne every 2 weeks and compliance was recorded on study calendars. The group washing their faces twice daily saw a significant improvement in their noninflammatory acne lesions (P = .03) and open comedones (P = .03) over the study period. During the latter half of the study period, the group washing their faces once daily experienced a significant increase in erythema (P = .05), inflammatory acne lesions (P = .01), and papules (P = .01). However, no statistically significant changes were observed in the study group washing 4 times daily. Additionally, no statistically significant changes were observed between the study groups at any point in the study. The amount of face wash used also did not correlate statistically with any changes in acne condition, although a slight association was found between an increase in erythema and the amount of cleanser used per instance of face washing.
P109 ACNE-QUALITY OF LIFE INVENTORY (ACNE-QOLI): DEVELOPMENT AND VALIDATION Stephen Rapp, PhD, Department of Psychiatry, Wake Forest University School of Medicine, Winston-Salem, NC, United States; Steven Feldman, MD, PhD, Gloria Graham, MD, Alan Fleischer Jr, MD, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, United States
Overall, the effects of face washing on acne vulgaris may be minimal at best. While washing the face once or four times a day does not appear to have a significant impact on acne vulgaris, washing the face twice a day may be optimal, in terms of both efficacy and convenience.
Acne affects most people and can produce psychological, social, and affective problems for patients. Assessing the impact of acne on quality of life has been hampered by the lack of well-validated and reliable measures of acne-specific quality of life that are brief and easy to administer. The poster reports the development and validation of the Acne Quality of Life Index (Acne-QOLI). Systematic focus groups with people from demographically different populations were conducted to identify the relevant domains of functioning and to develop item content. Four hundred eighty persons ranging in age from 12 to 62 years completed a survey that included 58 test items and other measures. Factor analysis was used to reduce the item pool to 21 items. Construct validity, concurrent validity, internal consistency, and test-retest reliability were systematically evaluated. High internal consistency and test-retest reliability were found. Similarly the 21-item Acne-QOLI showed excellent face validity, concurrent validity, and construct validity. Quality of life is increasingly being considered as a primary outcome in health care. The Acne-QOLI is a brief, easily administered measure of acne-related quality of life that can be used in clinical care, research, and product development.
Nothing to disclose.
Supported by Johnson & Johnson
P12
J AM ACAD DERMATOL
MARCH 2005
P108
A QUALITATIVE AND QUANTITATIVE ASSESSMENT OF THE APPLICATION AND CONSUMPTION OF TOPICAL ACNE MEDICATION BY PATIENTS James Del Rosso, DO, University of Nevada School of Medicine, Las Vegas, NV, United States
A TWO-CENTER PATIENT PREFERENCE STUDY COMPARING TWO ACNE GELS Emil Tanghetti, MD, Center for Dermatology and Laser Surgery, Sacramento, CA, United States; Michael Gold, MD, Tennessee Clinical Research Center, Inc., Nashville, TN, United States; Joanne Fraser, PhD, A. C. Stiefel Research Institute, Inc., Oak Hill, NY, United States A new, topical acne gel containing 1% clindamycin and 5% benzoyl peroxide in a ready-to-dispense formulation was compared to another topical acne gel also containing 1% clindamycin and 5% benzoyl peroxide for local tolerance and efficacy. The new gel is indicated for once-daily treatment of inflammatory acne and is available in a tube. The other gel product is indicated for the twice-daily treatment of acne vulgaris, must be mixed in the pharmacy before dispensing, and comes in a jar. Both products are stored at room temperature after dispensing to the patient.
Management of acne requires proper application and compliance with medication use. In this trial, careful documentation of topical medication consumption and methods of application are completed, with photographic methods used to determining area of medication coverage. Data are collected from study periods both before and after the use of a designated patient instruction program. The poster discusses the implications of vehicle type, application methodologies, and patient education on compliance, efficacy, longevity of use of a fixed amount of product and cost. Stiefel, Galderma, Medicis, Dermik, Healthpoint, Allergan. 100% sponsored by Stiefel
This study explored factors that are influential in determining patient preference in acne medication selection. The study was a crossover design in which subjects with mild to moderate acne vulgaris were assigned to 2 weeks of treatment with each medication randomized to either the first or second period. Treatment periods were separated by a 2-week washout period. Use of topical moisturizers on the face was prohibited during the study. A clinical assessment including inflammatory lesion count, noninflammatory lesion count, peeling, erythema, and dryness was performed at baseline and week 2 of each study period by a blinded evaluator. Subjects completed questionnaires concerning packaging acceptability and safety and efficacy after 2 weeks of treatment. At the end of the study, subjects completed a preference questionnaire concerning safety, efficacy, dosing regimen, and packaging. Dr. Fraser is an employee of the manufacturer. 100% sponsored by Stiefel Laboratories, Inc.
P107 A SINGLE-BLINDED, RANDOMIZED, CONTROLLED, CLINICAL TRIAL EVALUATING THE EFFECT OF FACE WASHING ON ACNE VULGARIS Alexa Kimball, MD, MPH, Joanna Mimi Choi, BS, Vincent Lew, BS, Stanford University, Stanford, CA, United States The relationship between face washing and acne vulgaris is a confusing one. While the general public associates poor hygiene with bad acne, dermatologists also caution that too much face washing can exacerbate the condition. Moreover, the recommendation to wash the face twice daily with a mild cleanser has little supporting evidence. Consequently, we conducted a single-blinded, randomized, controlled, clinical trial to evaluate the effect of face washing on acne vulgaris. Male subjects with mild to moderate acne were recruited for our study and allowed to continue any ongoing acne treatments, except for medicated face wash (n = 34). After an initial 2-week wash-in period of washing the face twice daily with the same mild cleanser, participants were randomized into 3 study groups (n = 9,9,9) and washed their faces once, twice, or four times daily for a 6-week study period. A trained and blinded evaluator graded subjects’ acne every 2 weeks and compliance was recorded on study calendars. The group washing their faces twice daily saw a significant improvement in their noninflammatory acne lesions (P = .03) and open comedones (P = .03) over the study period. During the latter half of the study period, the group washing their faces once daily experienced a significant increase in erythema (P = .05), inflammatory acne lesions (P = .01), and papules (P = .01). However, no statistically significant changes were observed in the study group washing 4 times daily. Additionally, no statistically significant changes were observed between the study groups at any point in the study. The amount of face wash used also did not correlate statistically with any changes in acne condition, although a slight association was found between an increase in erythema and the amount of cleanser used per instance of face washing.
P109 ACNE-QUALITY OF LIFE INVENTORY (ACNE-QOLI): DEVELOPMENT AND VALIDATION Stephen Rapp, PhD, Department of Psychiatry, Wake Forest University School of Medicine, Winston-Salem, NC, United States; Steven Feldman, MD, PhD, Gloria Graham, MD, Alan Fleischer Jr, MD, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, United States
Overall, the effects of face washing on acne vulgaris may be minimal at best. While washing the face once or four times a day does not appear to have a significant impact on acne vulgaris, washing the face twice a day may be optimal, in terms of both efficacy and convenience.
Acne affects most people and can produce psychological, social, and affective problems for patients. Assessing the impact of acne on quality of life has been hampered by the lack of well-validated and reliable measures of acne-specific quality of life that are brief and easy to administer. The poster reports the development and validation of the Acne Quality of Life Index (Acne-QOLI). Systematic focus groups with people from demographically different populations were conducted to identify the relevant domains of functioning and to develop item content. Four hundred eighty persons ranging in age from 12 to 62 years completed a survey that included 58 test items and other measures. Factor analysis was used to reduce the item pool to 21 items. Construct validity, concurrent validity, internal consistency, and test-retest reliability were systematically evaluated. High internal consistency and test-retest reliability were found. Similarly the 21-item Acne-QOLI showed excellent face validity, concurrent validity, and construct validity. Quality of life is increasingly being considered as a primary outcome in health care. The Acne-QOLI is a brief, easily administered measure of acne-related quality of life that can be used in clinical care, research, and product development.
Nothing to disclose.
Supported by Johnson & Johnson
P12
J AM ACAD DERMATOL
MARCH 2005