ACNE

P6273A double-blind, placebo-controlled evaluation of a 2% salicylic acidcleanser for improvement of acne vulgaris

Jacqueline Woodruff, Johnson & Johnson Consumer Companies, Inc, Skillman,NJ, United States; Yohini Appa, PhD, Neutrogena Corporation, Los Angeles, CA,United States

Acne is a persistent condition that is seen in the dermatology office on a daily basisand is a significant cause of concern for many patients. Practicing dermatologistshave recognized that patient compliance often becomes an issue with acnetreatments because of the dryness and flaking associated with many effectivetopical products. In addition, some patients are unwilling to embrace a treatmentregimen with multiple steps. Both of these issues can be addressed through thecommon daily ritual of facial cleansing with a gentle but effective cleansingformulation that can deposit topical acne medication. In this way, patients caneffectively treat their mild to moderate acne during the cleansing process. This is anexcellent option for teens and adults who have oily, acne prone skin, because thecleansing regimen is a key component in their daily routine. A double-blind, placebo-controlled clinical study (N ¼ 30 patients per cell) was initiated to evaluate thebenefits of a 2% salicylic acid facial cleanser for acne. Patients were between 12 and30 years of age and presented withmild to moderate acne vulgaris. Expert grading oflesions was performed at multiple time points throughout the 8 week usage period.Follicular biopsies were obtained at the 2-week time point and were analyzed forsalicylic acid deposition. This 2% salicylic acid cleansing formulationwas found to bewell-tolerated and provided significant reductions in acne lesion counts throughoutthe entire product usage interval. This gentle, nondrying cleanser provides a newoption for patients who are best suited for a simple daily approach to treating theiracne, which is both effective and well tolerated.

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d by Johnson & Johnson Consumer Companies, Inc

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P6021A metaanalysis to investigate the relationship between Fitzpatrick skintypes and tolerability of adapaleneebenzoyl peroxide topical gel inpatients with mild or moderate acne

Valerie D. Callender, MD, Callender Skin and Laser Center, Bowie, MD, UnitedStates; Lori A. Johnson, PhD, Galderma Laboratories, L.P., Fort Worth, TX, UnitedStates; Norman Preston, PhD, Galderma Laboratories, L.P., Fort Worth, TX,United States; Ronald W. Gottschalk, MD, Galderma Laboratories, L.P., FortWorth, TX, United States

Acne therapy in darker skin patients may present unique concerns because of therisk of postinflammatory hyperpigmentation. One combination treatment currentlyavailable is a gel formulation containing a retinoid (adapalene 0.1%) in fixedcombination with an antimicrobial (benzoyl peroxide 2.5%). Results from 3randomized, double-blind, vehicle-controlled, clinical trials of adapaleneebenzoylperoxide (A-BPO) gel were combined in a retrospective metaanalysis that included909 patients treated for 12 weeks and assessed at each visit for erythema, scaling,dryness, and stinging/burning. Only week 1 results were included in the metaanal-ysis because the worst severity of cutaneous irritation was found to occur at thistime point in all 3 trials. There were no statistically significant differences in dryness,scaling, and stinging/burning with A-BPO gel treatment when patients withFitzpatrick skin types I to III were compared to patients with Fitzpatrick skin typesIV to VI. Erythema assessments were statistically different based on skin types,because patients with Fitzpatrick skin types IV to VI were rated as having noerythema more often than those with Fitzpatrick skin types I to III (P\.001). Acnepatients with Fitzpatrick skin types IV to VI were not found to be more susceptibleto cutaneous irritation from treatment with the A-BPO gel than patients withFitzpatrick skin types I to III.

d by Galderma Laboratories, L.P.

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J AM ACAD DERMATOL

P6108A phase IV, open label study evaluating the use of minocycline HClextended release tablets with topical bactericidal and antibiotic/retinoidpreparations as a triple combination acne therapy for potential isotreti-noin candidates

Andrea Zaenglein, MD, The Pennsylvania State University College of Medicine,Division of Dermatology, Hershey, PA, United States; Diane Thiboutot, MD, ThePennsylvania State University College of Medicine, Hershey, PA, United States;Xiaoming Lin, MS, RN, Medicis Pharmaceutical Corporation, Scottsdale, AZ,United States

Patients with moderate/severe acne vulgaris may be candidates for oral isotretinoin,a highly regulated therapy associated with controversial adverse events (AEs). Anoral antibiotic, topical antibiotic/retinoid, and benzoyl peroxide (BPO) combinationis often used in patients with moderate/severe acne, but data are limited on thisregimen’s efficacy. This study assessed the efficacy and safety of a triple combinationtherapy in patients with moderate/severe facial acne to determine if such therapycould avoid the need for isotretinoin. Patients (N ¼ 97) aged 12 to 29 years withsevere acne (grades 3-4 acne, Investigator’s Global Assessment [IGA]) who werepotential candidates for isotretinoin were given triple combination therapy (min-ocycline HCl extended release z1 mg/kg QD, clindamycin phosphate 1.2%/treti-noin 0.025% gel, 6% BPO foaming cloths). Patients were evaluated at baseline (BL)and weeks 2, 4, 8, and 12. At week 12, 89% and 96% of patients had at least a 1-gradeimprovement from BL by IGA and Global Aesthetic Improvement Scale. Mean (SD)inflammatory, noninflammatory, and total lesion counts decreased by 61.8%(38.3%), 48.8% (34.5%), and 56.5% (29.9%) from BL. Of 90 patients for whomphotographs were available at BL and week 12, 69 (77%) were candidates forisotretinoin at BL, as judged by independent photographic reviewers. At week 12, 76(84%) patients were no longer considered candidates for isotretinoin therapy.Treatment-emergent AEs occurred in 18 of 97 (19%) patients, all deemedmild/moderate and most were not treatment related. Related AEs (8/97) wereconsistent with those reported for individual medications. Triple combinationtherapy was not associated with any serious AEs or AEs leading to discontinuation.Investigator assessments generally indicated that small increases from BL inmild/moderate irritation at weeks 2 and 4 decreased by weeks 8 and 12. Rednesswas the most common symptom reported by patients (57% by week 2, 45% by week12; most were mild). Most patients reported no itching, burning, or stinging. Triplecombination therapy was well tolerated and substantially reduced facial acne lesioncounts and number of candidates for isotretinoin. These data support the clinicalobservation that a triple combination regimen of an extended release oral antibiotic,topical antibiotic/retinoid, and BPO foaming cloths improves moderate/severe acnewith[80% of patients judged to no longer be candidates for isotretinoin therapy bystudy end.

nsored by Medicis Pharmaceutical Corporation.

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P7144A single-center, prospective study on the efficacy and safety of micro-focused ultrasound for the noninvasive treatment of moderate to severefacial acne

Girish (Gilly) Munavalli, MD, MHS, Dermatology, Laser, and Vein Specialists of theCarolinas, PLLC, Charlotte, NC, United States

Background: Acne is a very prevalent skin disorder, affecting[85% of adolescentsand often continuing into adulthood. The objective of this pilot study was toevaluate microfocused ultrasound (MFU) for the efficacy and safety for noninvasivetreatment of moderate to severe combination inflammatory and comedonal facialacne.

Methods: Ten subjects, at least 18 years of age with moderate to severe acne (at least20 each of inflammatory papulopustular and comedonal lesions), were treated withMFU on the forehead, temples, medial cheek, and chin regions. Subjects received 3treatments approximately 14 days apart with both a 1.5-mm/10-MHz and 1.0-mm/10-MHz transducer. Subject’s pain was measured immediately posttreatment.Photographswere taken before and immediately posttreatment and at 14, 30, 60, 90,and 180 days. The primary efficacy endpoint was measured by reduction in totallesion count of inflammatory and noninflammatory lesions at 60 days after the thirdtreatment compared to baseline. Other secondary efficacy endpoint measuresincluded improvement in skin clarity based on evaluation of standardized images,modified Global Acne Grade score (mGAGS), and sebumeter measurement ofmultiple sites in the treatment zone. Subject satisfaction was collected at 60 and 180days posttreatment 3. Safety, based on AE incidence, was assessed.

Results: Ten subjects, ranging from 18 to 26 years of age (mean 21) with a meanpretreatment BMI of 24.8 kg/m2 (range, 18.1-34.1) were treated. At interim analysistime point, 57.1% of subjects had a decrease in noninflammatory lesions and 85.7%in inflammatory lesions and total lesion count at 60 days compared to baseline. Theaverage global reduction in sebum production, as assessed by sebumeter measure-ment (Courage-Khazaka, Koln, Germany) was 70.6%. All subjects noticed animprovement at 60 and 180 days with a ‘‘reduction in number of acne lesions’’and ‘‘clearer skin’’ the most reported improvements at both follow-up time points.All subjects were satisfied or very satisfied at 60 days and 180 days. No seriousadverse events were reported. No treatment-related adverse events were reported.

Conclusion: Data from this pilot study suggests that MFU technology could be apromising novel treatment option for the reduction of acne lesions in subjects withmoderate to severe combination inflammatory papulopustular and comedonal acne.

nsored by Ulthera.

100% spo

APRIL 2013