P8119Common use of prescription off-label therapy for acne in the pediatricpopulation <12 years old

Sonal Parikh, Wake Forest School of Medicine, Winston-Salem, NC, United States;Scott Davis, Wake Forest School of Medicine, Winston-Salem, NC, United States;Steven Feldman, MD, PhD, Wake Forest School of Medicine, Winston-Salem, NC,United States

Background: Acne is occurring more frequently in younger age groups, but mostavailable treatments are considered ‘‘off-label’’ in young children. Regulators havebeen slow to adapt to the changing epidemiology of acne and expand the indicationto include younger age groups.

Objective: To analyze the frequency of off-label acne treatment by age and otherdemographic factors.

Methods: We searched the National Ambulatory Medical Care Survey (NAMCS) for1993-2010 for visits in children aged under 12 for the diagnosis of ICD-9 code 706.1.We tabulated leading acne treatments and assessed factors associated with off-labelprescribing.

Results: Off-label but appropriate acne treatmentswere used in 29% of acne visits forchildren under 12. Dermatologists were more likely to prescribe off-label treatmentthan pediatricians (P\.0001). The most frequent off-label treatments used weretopical retinoids, followed by oral antibiotics. There was no significant trend in therate of off-label prescribing over time (P ¼ .4).

Limitations: The data reflect numbers of visits and not a direct measure of incidenceor prevalence.

Conclusions: Off-label treatment is well within the standard of care for youngchildren with acne. More data on the use of topical retinoids in young children mayhelp optimize treatment outcomes.

MAY 201

r for Dermatology Research is supported by an unrestricted edum Galderma Laboratories, L.P.

The Cente cationalgrant fro

P8662Effectiveness of adapalene/BPO gel in the first 4 weeks of treatment inacne patients

Linda Stein Gold, MD, Dermatology Clinical Research, Henry Ford Health System,West Bloomfield, MI, United States

Background: A fixed dose of adapalene/benzoyl peroxide (stabilized in the Simulgelvehicle) Gel 0.1%/2.5% has been shown in previous studies to be efficacious in thetreatment of acne vulgaris. To help physicians and patients establish a realistictreatment expectation for the first 4 weeks of therapy, a pooled analysis wasconducted to specifically evaluate the effectiveness and tolerability achieved in thistime frame.

Methods: Data from 14 studies, including 4 large vehicle-controlled studies (onewith patients as young as 9 years of age), were pooled to evaluate the effectivenessand tolerability of adapalene/benzoyl peroxide gel 0.1%/2.5% among acne subjectsduring the first 4 weeks of treatment. A total of 2,358 subjects between 9 years and61 years old were treated with adapalene/BPO gel 0.1%/2.5%. In most of thesestudies, adapalene/BPO gel 0.1%/2.5% was used for 12 weeks. Inflammatory lesioncounts, noninflammatory lesion counts, total lesion counts, and IGA scores were theendpoints.

Results: Inflammatory, noninflammatory, and total lesion counts decreased withadapalene/BPO gel 0.1%/2.5% use, showing a 40-50% reduction from baseline afterthe first 4 weeks of use. Adapalene/BPO gel 0.1%/2.5% was well tolerated amongdifferent skin types, ages, and genders, with most of the worst tolerabilityassessments being none or mild.

Discussion: Adapalene/BPO gel 0.1%/2.5% was well tolerated and reducedapproximately half of the inflammatory and noninflammatory lesion counts at 4weeks. The effects seen in the first 4 weeks from these studies are consistent withthose already demonstrated in individual vehicle-controlled studies. These observa-tions provide a framework of expectations for adapalene/BPO gel 0.1%/2.5%treatment during the first 4 weeks of treatment for clinicians to discuss with theirpatients.

d by Galderma Laboratories, L.P.

Supporte

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P8669Efficacy and safety of subantimicrobial dose, modified release doxycy-cline 40 mg vs doxycycline 100 mg vs placebo in the treatment of severeacne

Angela Moore, MD, Arlington Center for Dermatology, Arlington, TX, UnitedStates; Alicia D. Bucko, DO, Academic Dermatology Associates, Albuquerque,NM, United States; Joyce Hwa, RN, Galderma R&D, Inc, Cranbury, NJ, UnitedStates; Mark R. Ling, MD, PhD, Newnan Deramtology, Newnan, GA, UnitedStates; Susan Qi, MS, Galderma R&D, Inc, Cranbury, NJ, United States; VasantManna, MD, Galderma R&D, Inc, Cranbury, NJ, United States

Background: Doxycycline (DC) 100 mg is used in the treatment of moderate tosevere acne vulgaris, although routine use may be associated with patient safety andpublic health issues, such as antibiotic resistance. Recent clinical data havesuggested that the use of subantimicrobial doses of DC may have the potential totreat inflammatory lesions of acne with a lower risk of adverse events (AEs)compared to antibiotic doses of DC.

Objective: Evaluate the safety and efficacy of subantimicrobial dose, modifiedrelease DC 40 mg in the treatment of inflammatory lesions of acne compared to 100mg DC (vs placebo).

Methods: This multicenter, randomized study included a total of 662 patients aged12 years or older with moderate to severe acne and facial involvement (25-75inflammatory lesions). Patients received DC 40 mg tablets (n ¼ 216), DC 100 mgcapsules (n ¼ 224), or placebo (n ¼ 222) once daily for 16 weeks. Efficacyassessments included lesion counts (inflammatory, noninflammatory, and total) andsuccess rate (percentage of patients who achieved ‘‘clear’’ or ‘‘almost clear’’ score)based on investigator global assessment (inflammatory).

Results: DC 40 mg was statistically superior to placebo in the reduction of thenumber of inflammatory lesions (16.1 vs 12.6; P ¼ .006), percent reduction ininflammatory lesions (51.6% vs 44.3%; P¼.003) and total lesions (41.7% vs 34.1%; P¼ .004), and success rate (14.4% vs 7.7%, respectively; P ¼ .025). A reduction innoninflammatory lesions was observed vs placebo, but was not statisticallysignificant (10.0 vs 5.8, respectively; P ¼ .445). DC 40 mg showed superioritycompared to DC 100 mg in the reduction of the number of inflammatory lesions(16.1 vs 12.9; P¼.024), and percent reduction of total lesions (41.7% vs 35.9%; P¼.026), with nonsignificant numerical differences observed for percent reduction ininflammatory lesions (51.6% vs 47.3%; P ¼.106), success rate (14.4% vs 13.8%; P ¼.877), and reduction of noninflammatory lesions (10.0 vs 5.2, respectively; P ¼.079). The incidence rate of drug-related AEs for DC 40 mg was similar to placebo(3.7% vs 4.1%, respectively). The number of drug-related AEs was markedly smallerfor DC 40 mg compared to DC 100 mg (11 vs 50, respectively; nausea [3 vs 12],vomiting [0 vs 14]).

Conclusions: DC 40 mg demonstrated comparable efficacy and superior safetyprofile to DC 100mg, with a comparable safety profile to placebo in the treatment ofmoderate to severe acne.

d by Galderma Research & Development, SNC.

Supporte

P8441Efficacy and tolerability of a topical treatment in adult female subjectswith mild to moderate facial acne and postinflammatory lesions

Elizabeth Makino, MBA, SkinMedica, Inc, an Allergan Company, Carlsbad, CA,United States; Rahul Mehta, PhD, SkinMedica, Inc, an Allergan Company,Carlsbad, CA, United States

Dryness and irritation are common side effects associated with topical acnetreatments due to the presence of keratolytic ingredients such as tretinoin, benzoylperoxide, or salicylic acid. Although effective when consistently applied, tolerabilityconcerns linked to these ingredients may compromise patient compliance. Acnelesions are also associated with the development of postinflammatory changes (ie,postinflammatory hyperpigmentation [PIH] or postinflammatory erythema [PIE])further aggravating the aesthetic concerns linked to this skin pathology. Therefore,in an attempt to minimize unwanted acne-associated side effects, withoutcompromising efficacy, we have created a new topical formulation that containsstrong antioxidant and antiinflammatory ingredients as well as salicylic acid (2%)and 4-ethoxybenzaldehyde. Tolerability and efficacy were evaluated by a 12 weekopen-label, single-center clinical study. Female subjects aged 25 years and older withmild to moderate facial acne and Fitzpatrick skin types I-V were included in thisstudy. Subjects were instructed to apply the acne lotion twice daily (morning andevening) after cleansing. A target inflammatory lesion (TIL) and a target post-inflammatory lesion (TPIL) were selected at baseline for further evaluation.Investigator’s global assessment of acne severity (IGA), acne lesion counts, andtolerability assessments (erythema, burning/stinging, dryness/scaling and itching)were conducted at baseline, 24 and 48 h and at weeks 4, 8 and 12. The TIL wasassessed at baseline, 24 and 48 hours, while the TPIL was assessed at baseline and atweeks 4, 8 and 12. Standardized digital photographywere taken at all visits and a self-assessment questionnaire was performed at weeks 4, 8 and 12. Twenty-three femalesubjects completed the 12-week study. Significant reductions in mean scores for IGAand inflammatory lesion counts were observed at 48 h and weeks 4, 8 and 12 (P\.02). Significant reductions in the TIL and TPIL occurred at all visits (P\.001). Theacne lotion was very well-tolerated with mean tolerability scores remaining belowmild. The study suggests that our new acne lotion may provide a comprehensivesolution for patients seeking an effective, nondrying treatment for mild to moderateacne as well as postinflammatory lesions.

d 100% by SkinMedica, Inc, an Allergan Company.

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J AM ACAD DERMATOL AB7