A3-step acne-treatment system has been developed

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2 Evaluatin f a Slubilized Benzyl Perxide Gel: A Pled Analysis Frm Randmized Investigatr-Blinded linical Trials James Q. Del Rss, DO A-step acne-treatment system has been develped utilizing a nvel slubilized 5% benzyl perxide (BPO) gel alng with 2% salicylic acid tner and 2 % salicylic acid cleanser. Accrding t data frm cmparative clinical trials that included actively treated subjects with acne vulgaris, mntherapy with the -step acne-treatment system and mdified regimens f the system that included the slubilized serum gel appear t be mre effective than the cmbinatin BPO and clindamycin gel Qar gel frmulatin) in reducing nninflammatry lesins, and at least as effective as the BPO and clindamycin gel in reducing inflammatry lesins.' Favrable skin tlerability and high levels f patient satisfactin were als bserved in clinical trials with slubilized BPO gel regimens. The -step acnetreatment system is nt available ver the cunter and can be btained nly thrugh a physician. The biavailability f BPO in many cmmercially successful frmulatins may be variable r incnsistent wing t its pr slubility. BPO particulate size may vary markedly, resulting in incnsistent r subptimal fllicular penetratin. These are imprtant characteristics, as a majr gal f BPO therapy is t reduce Prpinibacterium acnes rganisms. A nvel frmulatin f slubilized BPO has been develped that helps maximize the biavailability f 1PO and enhances its penetratin int fllicles. This frmulatin is available Dr. Del Rss is linical Assciate PrfessOl; Dermatlgy, University f Nevada Schl f Medicine, Las Vegas, linical Assciate Prfessr; Dermatlgy, Tur University llege f Ostepathic Medicine, He/1dersn, Nevada, and Dermatlgy Residency DirectOl, Valley Hspital Medical ente1; Las Vegas. D1: Del Rss is a cnsultant, speaker; and researcher fr Allergan, Inc; ria Labratries; Galdenna Labratries, LP; Intendis GmbH; Medicis Pharmaceutical rpratin; Obagi Medical Prducts; OrthNeutrgena; QLT Inc; ShinMedica; and Stiefel Labratries, I/le. as part f a -step acne-treatment system that als incrprates the use f a prprietary tner and cleanser, bth f which cntain 2% salicylic acid.' Methds Treatment Regimens Data were pled frm patients wh participated in 1 f randmized investigatr-blinded trials (Table 1) evaluating the use f slubilized 5% BPO gel alne, the slubilized 5% BPO gel alng with 2% salicylic acid tner and 2 % salicylic acid cleanser (-step acne-treatment system), and a cmbinatin BPO and clindamycin gel prduct (jar gel frmulatin) 2. Depending n the trial, each treatment was applied nce r twice daily fr 2 t 4 weeks. Patients were evaluated at weekly intervals. Inclusin riteria Patients included in the trials were 11 t 45 years f age with mild t mderate acne cnsisting f 17 t 1 inflammatry lesins and 1 t 1 nninflammatry lesins. Descriptins f the tlerability ratings f "nne," "mild," "mderate," and "severe," can be fund in Table 2. Subjects were willing t refrain frm sunbathing and using ther acne medicatins during the study. Exclusin riteria The exclusin criteria fr the trials were allergies t BPO, papulpustular rsacea and ther skin diseases n the face (ther than acne) that might interfere with the study evaluatins, a beard if it might interfere with the study evaluatins, facial sunburn at the screening visit, and uncntrlled systemic diseases as determined by the investigatr. Washut Perids The washut perids required befre enrllment and randmizatin were as fllws: 1 week fr medicated facial cleansers; 2 weeks fr tpical a -hydrxy acids and VOL. 21 NO. 4, APRIL 2H smetic Dermatlgy" 21

3 BENH Tp TO BEDSIDE Patients Evaluated, N. Slubilized 5% BPa Gel + 2% Prescriptin Salicylic Acid BPa/ Tner ± 2% lindamycin Slubilized 5% Salicylic Acid mbinatin Study Treatments Evaluated Regimen BPa Gel leanser Gel Prduct NOA9S*2 Slubilized 5% spa gel Twice daily NA % salicylic acid tner fr 2 wk 5% SPO/clindamycin cmbinatin prduct NOA1A*1 Slubilized 5% spa gel Twice daily Slubilized 5% spa gel + 2% salicylic acid tner + 2% salicylic acid cleanser 5% SPO/clindamycin cmbinatin prduct fr 4 wk NOA1Y Slubilized 5% spa gel Once r NA % salicylic acid tner twice daily + 2% salicylic acid fr wk cleanser Ttal Abbreviatins: BPO, benzyl perxide; NA. nt applicable. ' All r sme patients treated in split-face manner. Such patients prvide 2 sets f treatment data (ne fr the left facial side and ne fr the right facial side). antiacne medicatins (except tpical retinids and antibitics); and 4 weeks fr tpical retinids, tpical and systemic antibitics, and tpical and systemic crticsterids. Outcme Measures Efficacy Outcme measures related t efficacy were changes in nninflammatry lesin cunt (mean percent reductin) and inflammatry lesin cunt (mean percent reductin). Lcal Tlerability Lcal tlerability was assessed by capturing ptential reactins, including stinging and burning, erythema, dryness. and itching. The rating scale definitins fr these specific findings are included in Table 2. Patient Satisfactin Assessment Patient satisfactin was evaluated in 2 f the trials, NOA1 and NOAOlOA, and was nt assessed in study NOA9B. Parameters were evaluated separately in studies NOA1A and NOA1 wing t differences in the scales used. Bth studies assessed satisfactin with the imprvement in acne (rated as "very satisfied," "satisfied," "smewhat satisfied," "neutral/indifferent," r "di,satisfied"). In the NOA1 study, the fllwing assessment was included: prducts leave the skin feeling refreshed and have acceptable tlerability (rated as "agree cmpletely," "smewhat agree," "neither agree nr disagree," "smewhat disagree," r "disagree cmpletely"). In the NOAOlOA study, the fllwing assessment was included: prducts leave the skin feeling refreshed and feel like 22 smetic Dermatlgy@ APRIL 28 Val.. 21 NO.4

BENH Tp TO BEDSIDE Scre StininBurnins Erl:thema Drl:ness Itchins Nne Nne-n erythema Nne Nne (may be minr disclratin) Mild-light, warm tingling Mild-light pink, Mild-slight but Mild-ccasinal,

4 BENH Tp TO BEDSIDE Scre StininBurnins Erl:thema Drl:ness Itchins Nne Nne-n erythema Nne Nne (may be minr disclratin) Mild-light, warm tingling Mild-light pink, Mild-slight but Mild-ccasinal, sensatin, nt really nticeable definite rughness slight itching bthersme 2 Mderate-definite warmth, Mderate-pink-red, Mderate-mderate Mderate-cnstant r tingling/stinging sensatin nticeable rughness intermittent itching that is smewhat bthersme that is smewhat bthersme Severe-ht tingling/stinging Severe-deep r Severe-marked Severe-bthersme sensatin that is disturbing bright red, may be rughness itching that is 'nrmal activity warm t the tuch disturbing nrmal activity they are wrking (rated as "excellent," "gd," "fair," r "pr"), Patient Demgraphics The mean age f included subjects was 2 years. Mst were white (82.7%), and the remainder were African American (157%) and Asian American (16%).2. The distributin f females and males was prprtinally cmparable (52% vs 48%, respectively). Half f the subjects were Fitzpatrick skin type. Statistical Analysis Intent-t-treat analyses were used fr statistical evaluatin f study results. A P value f :5.5 was cnsidered t signify statistical Significance. Efficacy data are reprted here; hwever, wing t the differing designs f the studies in this pled analysis (split-face versus full-face), the statistical Significance f between-grup differences in efficacy and tlerability parameters culd nt be reliably evaluated. Patient satisfactin data did allw fr betweengrup differences t be evaluated using the Wilcxn rank-sum test. Efficacy Results Nninflammatry Lesins The mean percent reductin in nninflammatry lesin cunt was greater with the slubilized 5% BPO regimens than with BPO and clindamycin gel at bth week 2 and week 4 (Figure 1). Mean reductins were as fllws: 7% with the -step acne-treatment system, 29% with slubilized BPO gel, and 16% with BPO and clindamycin gel at week 2. The results at week 4 were 47%, 42%, and 28%, respectively. Inflammatry Lesins The mean reductin in inflammatry lesin cunt was cmparable acrss all regimens at week 2, exhibiting a range f 48% t 52% (Figure 2). At week 4, the mean reductin in inflammatry lesins was 65% with the -step acne-treatment system, 7% with slubilized BPO gel, and 61 % with BPO and clindamycin gel. Patient Satisfactin Data frm the NOA1 study demnstrated gd patient satisfactin with the -step acne-treatment system. At week, yerall mean scres shwed that patients were "satisfied" t "very satisfied" with the imprvement in their acne, "smewhat agreed" t "cmpletely agreed" that bth the tner and the cleanser in the system leave the skin feeling refreshed, and "smewhat agreed" t "cmpletely agreed" that each f the cmpnent parts f the acne system (the slubilized 5% BPO gel, the tner, and the cleanser) have acceptable tlerability. Additinally, in the NOAOlOA study, the slubilized VOL 21 NO. 4 ' APRIL 28' smetic Dermatlgy"' 2

BENH Tp TO BEDSIDE BPO/lindamycin Gel (N s7).. Slubilized 5% BPO Gel + 2% Salicylic Acid Tner:!: 2% Salicylic Acid Slubilized 5% BPO Gel (N=2) leanser (N 88) +- BPO/lindamycin Gel (N = s7).

5 BENH Tp TO BEDSIDE BPO/lindamycin Gel (N s7).. Slubilized 5% BPO Gel + 2% Salicylic Acid Tner:!: 2% Salicylic Acid Slubilized 5% BPO Gel (N=2) leanser (N 88) +- BPO/lindamycin Gel (N = s7).. Slubilized 5% BPO Gel + 2% Salicylic Acid Tner :!: 2% Salicylic Acid Slubilized S% BPO Gel (N = 2) leanser (N=88) Q _.-... II ::I :;8 c r:c._ E -'... >... II I'" u c;;:: c II.- E.c E :::e 5 z 2 4 O t "'''<: t------''r =:.,- - t-----:::s...,_ t '>.,--=,...-_.;:;;:: \ ''''''"'::::::=_ -=- -6 -' !:?f , II g :au r:c c , E I------_ ' II >- g'.s '>O";:---'!'l< c U E ""'Ii''<-: lij,! ] L ==:; Figure 1. Mean reductin in nninflammatry acne lesin cunt. Figure 2. Mean reductin in inflammatry acne lesin cunt.... BPO/Iindamycin Gel (N=2). Slubilized 5% BPO Gel (N=2).. Slubilized 5% BPO Gel + 2% Salicylic Acid Tner + 2% Salicylic Acid leanser (N = 1) 8 VI c.;::: v.. VI II :::e 4, :j: 2 t 2 4 Figure. Patient satisfactin that benzyl perxide (BPO)/clindamycin gel, slubilized 5% BPO gel, and slubilized 5% BPO gel with 2% salicylic acid tner and 2% salicylic acid cleanser leave the skin feeling refreshed and that the prducts feel like they are wrking. Asterisk indicates scale where 1 = pr, 2= fair, =gd, 4 = excellent; dagger, P$.Ol vs BPO/ciindamycin gel; duble dagger, P$.5 vs BPO/ciindamycin gel. 5% BPO gel alng with 2% salicylic acid tner and 2 % salicylic acid cleanser (-step acne-treatment system) was significantly superir t BPO and clindamycin gel fr satisfactin with the imprvement in acne (P.5 at week 2) and satisfactin that the prducts leave the skin feeling refreshed and feel like they are wrking (P.O l at week 1, P.5 at week ; Figure ). Tlerability Imprtantly, the mean levels f stinging and burning, erythema, dryness, and itching remained less than mild with all regimens at all time pints (Figures 4-7). The mean level f stinging and burning was slightly higher with the slubilized 5% BFO regimens than with BFO and clindamycin gel at week 1. Hwever, by week 4, stinging and burning were cmpletely absent in all grups (Figure 4). In the first 2 weeks, the mean levels f erythema and dryness were slightly higher with slubilized 5% BFO alne than with BFO and clindamycin gel (Figures 5 and 6). nclusin A -step acne-treatment system has been develped utilizing a nvel slubilized 5% BFO gel alng with 2% salicylic 24 smetic Dermatlgy@ APRlL 28' VOL. 21 NO. 4

6 BENH Tp TO BEDSIDE BPO/ Iindamycin Gel (N=57) ",Slubilized 5% BPO Gel (N - 2).. Slubilized 5% BPO Gel + 2% Salicylic Acid Tner:!: 2% Salicylic Acid leanser (N = 88) -, r Figure 4. Mean scre fr stinging/burning in patients using benzyl perxide (BPO)/clindamycin gel, slubilized 5% BPO gel, and slubilized 5% BPO gel with 2% salicylic acid tner and 2% salicylic acid cleanser. Asterisk indicates scale where O= nne, 1 = mild, 2 = mderate, = severe. BPO/ lindamycin Gel (N = 57) "'Slubilized S% BPO Gel (N= 2).. Slubilized 5% BPO Gel + 2% Salicylic Acid Tner:!: 2% Salicylic Acid leanser (N=88) 8 2 VI E II.c w s: II :::!E... I -_T 4 I I I 2 4 Figure 5. Mean scre fr erythema in patients using benzyl perxide (BPO)/clindamycin gel, slubilized 5% BPO gel, and slubilized 5% BPO gel with 2% salicylic acid tner and 2% salicylic acid cleanser. Asterisk indicates scale where = nne, 1 = mild, 2 - mderate, = severe. acid tner and 2 % salicylic acid cleanser. Accrding t data frm cmparative clinical trials that included actively treated subjects, mntherapy with the -step acne-treatment system in patients with acne vulgaris appears t be mre effective than the cmbinatin BPO and clindamycin gel Qar gel frmulatin) in reducing nninflammatry lesins, and at least as effective as the BPO and clindamycin gel in reducing inflammatry lesins 2. The slubilized BPO gel-used alne r as part f the -step acne-treatment system- ffers an effective and well-tlerated apprach t treating acne vulgaris, demnstrating enhanced fllicular penetratin f BPO and rapid reductin in acne lesin cunts. Favrable skin tlerability and high levels f patient satisfactin were als bserved in clinical trials with slubilized BPO gel regimens. This branded -step acne-treatment VOL. 21 NO. 4 ' APRIL 28 smetic Dermatlgy<i> 25

$BENH Tp TO BEDSIDE BPO/ Ii[ldamycin Gel (N = 57) + Slubilized 5% BPO Gel (N=2)... Slubilized 5% BPO Gel + 2% Salicylic Acid Tner ± 2% Salicylic Acid leanser (N=88) 8 2 11\ QI QI :i!: - I... -- '!$

7 BENH Tp TO BEDSIDE BPO/ Ii[ldamycin Gel (N = 57) + Slubilized 5% BPO Gel (N=2)... Slubilized 5% BPO Gel + 2% Salicylic Acid Tner ± 2% Salicylic Acid leanser (N=88) \ QI QI :i!: - I '!" * - -- I I I 2 4 r. Figure 6. Mean scre fr dryness in patients using benzyl perxide (BPO)/ciindamycin gel, slubilized 5% BPO gel, and slubilized 5% BPO gel with 2% salicylic acid tner and 2% salicylic acid cleanser. Asterisk indicates scale where O= nne, 1 =mild, 2=mderate, =severe.... BPO/lindamyci Gel (N = 57) + Slubilized 5% BPO Gel (N = 2)... Slubilized 5% BPO Gel + 2% Salicylic Acid Tner ± 2% Salicylic Acid leanser (N - 88).. 2 * QI... 11\ 1 :c...!:: c QI :i!: I 1 T, Figure 7. Mean scre fr itching in patients using benzyl perxide (BPO)/clindamycin gel, slubilized 5% BPO gel, and slubilized 5% BPO gel with 2% salicylic acid tner and 2% salicylic acid cleanser. Asterisk indicates scale where = nne; 1 = mild, 2 = mderate, = severe. system is nt available ver the cunter and can nly be btained thrugh the ffice f a physician. References 1. Tanghetti E, Kircik L, Dhawan S, et al. A multi-center, investigatrblinded, randmized study t evaluate the efficacy and tlerability f a slubilized 5% benzyl perxide cmpated t a 5% benzyl perxide/clindamycin gel in the treatment f mderate facial acne vulgaris (Prtcl 1a). Pster presented at: Winter linical Dermatlgy nference; March 14-18, 28; Maui, Hawaii. 2. Wilsn D, Meadws KP, Ramirez ]. A cmparisn f a nvel benzyl perxide system with a cmbinatin benzyl perxide and dindamycin prduct: a 2-week plit-fac e study f effectiveness and tlerability. Pster presented at: 65th Annual Meeting f the American Academy f Dermatlgy; February 2-6, 27; Washingtn, D.. Wilsn D. Evaluatin f a nvel acne treatment system designed t enhance the efficacy f benzyl perxide treatment: an investigatr-blind, randmized study. Pster presented at: Summer Meeting f the American Academy f Dermatlgy; August 1-5, 27; New Yrk, NY. 4. Obagi Medical. LENZlderm M.D.TM. intrd ucing a breakthrugh acne slutin frm Obagi. Ifrpatients/bagiclenzidermmd/c!enziderm.html. Accessed February 12, smetic Dermatlgy'" APRIL 28 VOL. 21 NO.4

JDDonline.com. Introduction. Methods Study Design Twenty-three patients enrolled in a 4-week, multicenter, investigator-blinded,

JDDonline.com. Introduction. Methods Study Design Twenty-three patients enrolled in a 4-week, multicenter, investigator-blinded, 534 Emil Tanghetti MD, a Leon Kircik MD, b David Wilson MD, c Sunil Dhawan MD d a. Center for Dermatology and Laser Surgery, Sacramento, CA b. Physicians Skin Care PLLC, Louisville, KY c. Education and