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Doxycycline 20-mg tablets administered twice daily as maintenance therapy for the treatment of acne
P122
P124
CONSTANT ATTENUATION OF ACNE BY A TWO–STEP REGIMEN CONTAINING BOTH SALICYLIC ACID AND BENZOYL PEROXIDE TREATMENTS Theresa Chen, PhD, Yohini Appa, PhD, Neutrogena Skincare Institute, Los Angeles, CA, United States; J. H. Herndon, MD, Presbyterian Hospital of Dallas, Dallas, TX, United States; Thomas Stephens, PhD, Thomas J. Stephens and Associates, Carrollton, TX, United States
DOXYCYCLINE 20-MG TABLETS ADMINISTERED TWICE DAILY AS MAINTENANCE THERAPY FOR THE TREATMENT OF ACNE Lawrence Parish, MD, Jefferson Medical College, Philadelphia, PA, United States; Jennifer L. Parish, MD, Jefferson Medical College, Philadelphia, PA, United States; Hirak B. Routh, MBBS, Paddington Testing Company, Inc., Philadelphia, PA, United States Oral antimicrobial therapy has become the mainstay of acne therapy with the tetracyclines, in particular doxycycline, proving highly efficacious. Because full dosing of doxycycline at 100 mg twice daily can be complicated by photosensitivity, gastrointestinal side effects, and vaginal candidosis, lower dosing could be advantageous.
Constant attenuation of acne over time is a challenge in the treatment of acne patients. To achieve persisted clearance, a daily two-step regimen with multiaction formulations was developed. The two-step regimen includes a salicylic acid (SA) acne cleanser that also contains glycolic acid, a benzoyl peroxide (BPO) lotion for nightly use, and a SPF15 lotion with a proprietary blend of synergistic naturals for daytime use. In a double-blind and randomized clinical evaluation, the two-step regimen with SA and BPO was compared with a leading, commercially available, three-step BPObased regimen. The clinical results showed that the two-step regimen with SA and BPO rapidly improved acne within 1 week and continued to further ameliorate over the course of treatment. Target pimple size, edema, and erythema were significantly reduced within 2 days (first time point). Significant reduction of full-face total acne lesion counts was seen as early as day 4. In comparison, the three-step BPO-based regimen showed significant reduction in global acne severity starting at week 4 and full-face acne lesions starting at week 2. Clinical images showed notable improvement in acne and in overall skin condition. Skin appears less red with a calm, smooth, and translucent quality that was absent before the treatment. Also observed was rapid and marked absconding of acne bacteria porphyrin as well as clogged pores, shedding light on the effects of the twostep regimen in reducing acne through shutting down the microcomedones—the invisible time bombs of acne. Drs. Chen, Appa, Herndon, and Stephens are either employed by or under contract to Neutrogena Corporation. 100% sponsored by Neutrogena Corporation
Studies evaluating subantimicrobial doses of doxycycline 20 mg twice daily (SD Doxy) for up to 18 months have demonstrated that this dose regimen maintains plasma concentrations below that required to exert an antimicrobial effect. This dose of doxycycline has been shown to inhibit the various inflammatory processes and to diminish the clinical manifestations of inflammatory acne, while significantly reducing the incidence of side effects, with no evidence of the development of microbial resistance. The objective of this 16-week outpatient study was to evaluate the safety and efficacy of SD Doxy as a maintenance treatment in patients who have obtained initial control of their acne by administration of doxycycline 100 mg daily. At the end of the study, most patients treated with SD Doxy had a similar or lower total lesion count of papules plus pustules from the week-8 visit to the week-16 visit. In addition, the clinician’s global score from week-8 visit to the week-16 visit was similar or improved. No significant adverse events were seen. SD Doxy was able to maintain the improvement initially achieved with a higher antimicrobial dose of doxycycline. SD Doxy should be considered as an option for maintenance therapy in acne. SD Doxy avoids the adverse effects associated with higher doses. Furthermore, longterm use of SD Doxy is not associated with antibiotic resistance because the doxycycline plasma levels do not reach the minimal inhibitory concentration at this dose. A grant for the clinical trial was given to Drs. Lawrence and Jennifer Parrish and Mr. Routh from CollaGenex Pharmaceuticals. One consultant with CollaGenex Pharmaceuticals. 90% supported by CollaGenex Pharmaceuticals
P125 P123 DEFINING CRITERIA USED TO EVALUATE RESPONSE TO TREATMENT OF ACNE VULGARIS: AN APPRAISAL OF PREVIOUSLY USED AND NEWER METHODOLOGIES James Del Rosso, DO, University of Nevada School of Medicine, Las Vegas, NV, United States Results from controlled studies form the basis of overall perceptions regarding the efficacy and safety of specific treatments. In acne vulgaris, determining statistical significance related to mean percentage reduction in inflammatory and noninflammatory lesion counts, investigator global assessment, and patient (subject) global assessment have formed the basis of most studies. Results may be affected by several mitigating factors related to inclusion and exclusion criteria and variations in study ‘‘power.’’ Recently, standards for evaluation of response to acne treatment have been changed, with new methodologies required throughout the approval process. For example, the standard of complete clearance has been introduced. How the newer methodologies compare with previous standards, and how new criteria will impact on the reporting and interpretation of trial results are reviewed in this poster. Specific study outcomes, including those reported in more recent trials with topical adapalene, are utilized as illustrative examples. Galderma, Medicis, Allergan Stiefel, Dermik, Healthpoint, Connetics 100% supported by Galderma
P16
J AM ACAD DERMATOL
EFFICACY ANALYSIS OF METRONIDAZOLE TREATMENT Helen Torok, MD, Trillium Creek Dermatology & Surgery, Medina, OH, United States Rosacea is an inflammatory disorder of the central aspect of the face characterized by various combinations of flushing, erythema, telangiectases, papules and pustules, ocular lesions, and, in severe cases, phymatous changes—typically rhinophyma. It is frequently triggered by highly idiosyncratic factors, including diet, environmental stressors, and topical medications. The pathophysiology of rosacea remains incompletely elucidated. It is believed to have vascular and immune components as well as epidermal barrier dysfunction. Because of the incomplete understanding of its pathophysiology, the management of rosacea has been somewhat empirical. The ‘‘gold standard’’ of rosacea management has been and continues to be topical metronidazole alone or in combination with oral antibiotics followed by metronidazole maintenance. The extreme sensitivity of the skin in rosacea mandates that topical therapy be well tolerated as well as efficacious in treating erythema and inflammatory lesions. Because rosacea is a chronic, recurring disease, maintenance therapy is necessary once lesions have resolved. This poster will review the efficacy and tolerability of metronidazole as monotherapy and in combination in the treatment and maintenance remission phases of rosacea. 100% supported by Galderma
MARCH 2005
P124
CONSTANT ATTENUATION OF ACNE BY A TWO–STEP REGIMEN CONTAINING BOTH SALICYLIC ACID AND BENZOYL PEROXIDE TREATMENTS Theresa Chen, PhD, Yohini Appa, PhD, Neutrogena Skincare Institute, Los Angeles, CA, United States; J. H. Herndon, MD, Presbyterian Hospital of Dallas, Dallas, TX, United States; Thomas Stephens, PhD, Thomas J. Stephens and Associates, Carrollton, TX, United States
DOXYCYCLINE 20-MG TABLETS ADMINISTERED TWICE DAILY AS MAINTENANCE THERAPY FOR THE TREATMENT OF ACNE Lawrence Parish, MD, Jefferson Medical College, Philadelphia, PA, United States; Jennifer L. Parish, MD, Jefferson Medical College, Philadelphia, PA, United States; Hirak B. Routh, MBBS, Paddington Testing Company, Inc., Philadelphia, PA, United States Oral antimicrobial therapy has become the mainstay of acne therapy with the tetracyclines, in particular doxycycline, proving highly efficacious. Because full dosing of doxycycline at 100 mg twice daily can be complicated by photosensitivity, gastrointestinal side effects, and vaginal candidosis, lower dosing could be advantageous.
Constant attenuation of acne over time is a challenge in the treatment of acne patients. To achieve persisted clearance, a daily two-step regimen with multiaction formulations was developed. The two-step regimen includes a salicylic acid (SA) acne cleanser that also contains glycolic acid, a benzoyl peroxide (BPO) lotion for nightly use, and a SPF15 lotion with a proprietary blend of synergistic naturals for daytime use. In a double-blind and randomized clinical evaluation, the two-step regimen with SA and BPO was compared with a leading, commercially available, three-step BPObased regimen. The clinical results showed that the two-step regimen with SA and BPO rapidly improved acne within 1 week and continued to further ameliorate over the course of treatment. Target pimple size, edema, and erythema were significantly reduced within 2 days (first time point). Significant reduction of full-face total acne lesion counts was seen as early as day 4. In comparison, the three-step BPO-based regimen showed significant reduction in global acne severity starting at week 4 and full-face acne lesions starting at week 2. Clinical images showed notable improvement in acne and in overall skin condition. Skin appears less red with a calm, smooth, and translucent quality that was absent before the treatment. Also observed was rapid and marked absconding of acne bacteria porphyrin as well as clogged pores, shedding light on the effects of the twostep regimen in reducing acne through shutting down the microcomedones—the invisible time bombs of acne. Drs. Chen, Appa, Herndon, and Stephens are either employed by or under contract to Neutrogena Corporation. 100% sponsored by Neutrogena Corporation
Studies evaluating subantimicrobial doses of doxycycline 20 mg twice daily (SD Doxy) for up to 18 months have demonstrated that this dose regimen maintains plasma concentrations below that required to exert an antimicrobial effect. This dose of doxycycline has been shown to inhibit the various inflammatory processes and to diminish the clinical manifestations of inflammatory acne, while significantly reducing the incidence of side effects, with no evidence of the development of microbial resistance. The objective of this 16-week outpatient study was to evaluate the safety and efficacy of SD Doxy as a maintenance treatment in patients who have obtained initial control of their acne by administration of doxycycline 100 mg daily. At the end of the study, most patients treated with SD Doxy had a similar or lower total lesion count of papules plus pustules from the week-8 visit to the week-16 visit. In addition, the clinician’s global score from week-8 visit to the week-16 visit was similar or improved. No significant adverse events were seen. SD Doxy was able to maintain the improvement initially achieved with a higher antimicrobial dose of doxycycline. SD Doxy should be considered as an option for maintenance therapy in acne. SD Doxy avoids the adverse effects associated with higher doses. Furthermore, longterm use of SD Doxy is not associated with antibiotic resistance because the doxycycline plasma levels do not reach the minimal inhibitory concentration at this dose. A grant for the clinical trial was given to Drs. Lawrence and Jennifer Parrish and Mr. Routh from CollaGenex Pharmaceuticals. One consultant with CollaGenex Pharmaceuticals. 90% supported by CollaGenex Pharmaceuticals
P125 P123 DEFINING CRITERIA USED TO EVALUATE RESPONSE TO TREATMENT OF ACNE VULGARIS: AN APPRAISAL OF PREVIOUSLY USED AND NEWER METHODOLOGIES James Del Rosso, DO, University of Nevada School of Medicine, Las Vegas, NV, United States Results from controlled studies form the basis of overall perceptions regarding the efficacy and safety of specific treatments. In acne vulgaris, determining statistical significance related to mean percentage reduction in inflammatory and noninflammatory lesion counts, investigator global assessment, and patient (subject) global assessment have formed the basis of most studies. Results may be affected by several mitigating factors related to inclusion and exclusion criteria and variations in study ‘‘power.’’ Recently, standards for evaluation of response to acne treatment have been changed, with new methodologies required throughout the approval process. For example, the standard of complete clearance has been introduced. How the newer methodologies compare with previous standards, and how new criteria will impact on the reporting and interpretation of trial results are reviewed in this poster. Specific study outcomes, including those reported in more recent trials with topical adapalene, are utilized as illustrative examples. Galderma, Medicis, Allergan Stiefel, Dermik, Healthpoint, Connetics 100% supported by Galderma
P16
J AM ACAD DERMATOL
EFFICACY ANALYSIS OF METRONIDAZOLE TREATMENT Helen Torok, MD, Trillium Creek Dermatology & Surgery, Medina, OH, United States Rosacea is an inflammatory disorder of the central aspect of the face characterized by various combinations of flushing, erythema, telangiectases, papules and pustules, ocular lesions, and, in severe cases, phymatous changes—typically rhinophyma. It is frequently triggered by highly idiosyncratic factors, including diet, environmental stressors, and topical medications. The pathophysiology of rosacea remains incompletely elucidated. It is believed to have vascular and immune components as well as epidermal barrier dysfunction. Because of the incomplete understanding of its pathophysiology, the management of rosacea has been somewhat empirical. The ‘‘gold standard’’ of rosacea management has been and continues to be topical metronidazole alone or in combination with oral antibiotics followed by metronidazole maintenance. The extreme sensitivity of the skin in rosacea mandates that topical therapy be well tolerated as well as efficacious in treating erythema and inflammatory lesions. Because rosacea is a chronic, recurring disease, maintenance therapy is necessary once lesions have resolved. This poster will review the efficacy and tolerability of metronidazole as monotherapy and in combination in the treatment and maintenance remission phases of rosacea. 100% supported by Galderma
MARCH 2005