Poster 101 Moisturizer Use Enhances Facial Tolerability of Tazarotene 0.1% Cream Without Compromising Efficacy in Patients With Acne Vulgaris Emil Tanghetti,1 Zoe Draelos,2 Pearl Grimes,3 Sunil Dhawan,4 Michael Gold,5 Leon Kircik,6 Lawrence Green,7 Angela Moore,8 Fran Cook-Bolden9 1Center for Dermatology and Laser Surgery, Sacramento, CA; 2Dermatology Consulting Services, High Point, NC; 3Vitiligo & Pigmentation Institute of Southern California, Los Angeles, CA; 4Center for Dermatology, Cosmetic and Laser Surgery, Fremont, CA; 5Tennessee Clinical Research Center, Nashville, TN; 6Physicians Skin Care PLLC, Louisville, KY; 7The George Washington University, Washington, DC; 8Arlington Center for Dermatology, Arlington, TX; 9The Skin Specialty Group, New York, NY • 6 months for systemic retinoids Table 1. Scale used to assess overall disease severity. • Mean levels of compliance were between “mostly compliant” and Efficacy Tolerability INTRODUCTION “very compliant” in both groups throughout the study. There were Score Overall disease severity no significant between-group differences in the degree of • The reduction in lesion counts with tazarotene + moisturizer was at • No adverse events considered probably or definitely related to treatment The use of any topical retinoid can involve a period of “retinization” in the first Treatment regimen 0 None—clear, no inflammatory lesions compliance. least as great as that with tazarotene alone at week 16: were reported. few weeks of treatment while the skin is adapting to the retinoid. During this • Patients were randomly assigned (on a 1:2 basis) to one of the following 1 Sparse comedones, with very few or no inflammatory lesions present period of acclimatization, some patients transiently experience dryness, – 57% vs. 46%, respectively, for papules plus pustules (Figure 1) regimens* for 16 weeks: 2 Mild comedones, with some small inflammatory lesions present; minimal • Moisturizer use was significantly greater in the tazarotene + • Mean scores for dryness were consistently lower with tazarotene + erythema, stinging, or peeling on treated skin—which potentially reduces erythema moisturizer group than in the tazarotene alone group (P≤.001). – 50% vs. 48%, respectively, for comedones (Figure 2). moisturizer than with tazarotene alone, with the difference being 1 – Once-daily tazarotene 0.1% cream ≤ patient compliance and, ultimately, efficacy. Importantly, retinization effects can 3 Comedones with an increasing number of inflammatory lesions compared to At week 2, mean levels of use were between “frequently” and significant at week 2 (P .01; Figure 3). The mean level of dryness at 1,2 be avoided or minimized by using a moisturizer, applying the retinoid sparingly, – Once-daily tazarotene 0.1% cream plus twice-daily moisturizing cream.† grade 2 “always” in the tazarotene + moisturizer group and between • Both regimens were associated with a comparable reduction in week 2 was “none to trace” with tazarotene + moisturizer and mean overall disease severity score. and initiating therapy slowly (for example, by using the retinoid in the lowest 4 Moderate comedones, a moderate number of small inflammatory lesions “a little” and “occasionally” in the tazarotene alone group. “trace to mild” with tazarotene alone. concentration available and/or by starting with applications every 2 or 3 days • In the tazarotene plus moisturizer group, the use of moisturizer was extending over a wide area of the face; erythema is increasing 1,3,4 before gradually increasing to once-daily applications). It is also important mandatory. In the tazarotene alone group, patients were allowed to use a 5 Comedones, an increasing number of inflammatory lesions compared to • Mean scores for peeling and erythema were also consistently lower with † that the patient uses a gentle skin care regimen. For example, they should use moisturizing lotion but only if absolutely necessary. grade 4, with some larger inflamed lesions Tazarotene 0.1% cream Tazarotene 0.1% cream tazarotene + moisturizer than with tazarotene alone, although there Tazarotene 0.1% cream + moisturizer only non-soap-based cleansers and avoid the use of abrasive products, peeling 6 Severe, numerous comedones, papules and pustules with larger inflamed Tazarotene 0.1% cream + moisturizer were no significant between-group differences (Figures 4 and 5). • All subjects were instructed to wash their face twice daily with a hydrating agents, astringents, and other drying products including salicylic acid lesions extending over much of the face; erythema may be pronounced Week cleanser† and then to rinse it thoroughly with warm water and to pat it dry 3 Moderate • Mean scores for burning (Figure 6) were almost identical with both preparations and harsh soaps and gels.3-5 024 6 8 10 12 14 16 gently with a soft towel before applying their assigned study product(s). 0 regimens and remained at “none to trace” throughout the study. Table 2. Scales used to assess dryness, peeling, erythema, burning, and perception of oiliness. Some patients use a moisturizer in conjunction with topical retinoid treatment -10 • Tazarotene was applied only in the evening and patients were instructed to Score Dryness Peeling Erythema Burning (since Perception • Mean scores for perception of oiliness were reduced similarly with both and yet, to our knowledge, there has been little or no research evaluating 2 Mild wait at least 5 minutes for it to dry before retiring to bed. the last visit) of oiliness -20 regimens from “trace” at baseline to “none to trace” at all subsequent whether this has any impact on efficacy. From a theoretical perspective, it could Mean Mean 0 Absent Absent Absent Absent Normal reduction peeling timepoints. be argued that the adjunctive use of a moisturizer might impair the absorption • In the tazarotene plus moisturizer group, patients were instructed to apply the None Smooth No redness Normal, in papule -30 score no discomfort plus pustule of a topical retinoid and therefore reduce its efficacy. However, it could also be evening dose of moisturizer approximately 20 minutes before the tazarotene. 1 Trace Both regimens showed comparable improvements in skin comfort. 1 Trace Trace Trace Trace Mild and count -40 • argued that, by enhancing tolerability, the moisturizer promotes optimal patient Barely perceivable dryness Fine peeling, Faint red or An awareness, localized (%) compliance and consequently might enhance efficacy. • During the study period, patients were not permitted to use any antibiotic for by palpation with barely pink coloration, but no -50 more than 14 days or to use tetracycline antibiotics. no accentuation of perceptible barely perceptible discomfort and skin markings, skin no intervention -60 CONCLUSIONS We therefore performed a multicenter, investigator-blind, randomized study of desquamation (flakes) required 0 None 024 6 8 10 12 14 16 patients with facial acne vulgaris to compare the efficacy and tolerability of • The use of acne medications, skin cleansers, and moisturizers was restricted to or fissure formation -70 Week Treatment with tazarotene 0.1% cream was generally well tolerated, tazarotene 0.1% cream alone with tazarotene 0.1% cream plus moisturizer. those provided as part of the study. 2 Mild Mild Mild Mild Mild Easily perceptible dryness Slight peeling Light red or Noticeable and diffuse with or without the adjunctive use of a moisturizer. The transient • The use of cosmetics that were not oil-based was permitted although no by palpation with pink coloration discomfort increase in mean dryness levels during the retinization period was small accentuation of skin causing Figure 1. Mean reduction in papule plus pustule count. Figure 4. Mean peeling score. change in cosmetic use was allowed during the study and no facial cosmetics markings but no intermittent (mean levels peaked at “trace” to “mild” in the tazarotene alone group) METHODS skin desquamation awareness and was likely not sufficient to trigger moisturizer use in many patients. were allowed to be applied prior to study visits. (flakes) or fissure formation Indeed, the average usage of moisturizer in the tazarotene alone group Tazarotene 0.1% cream Tazarotene 0.1% cream • Subjects were advised to limit excessive exposure to ultraviolet light and to use 3 Moderate Moderate Moderate Moderate Moderate was reported to be no more than occasional, which appears to confirm Study design Tazarotene 0.1% cream + moisturizer a sunscreen or wide-brimmed hat if exposure was unavoidable. Easily noted dryness Definitely Medium red Noticeable and diffuse Tazarotene 0.1% cream + moisturizer that the patients in this group did not experience troublesome levels with accentuation of noticeable coloration discomfort Week • Multicenter, investigator-blind, randomized, parallel-group study skin markings and peeling causing 3 Moderate of dryness. 024 6 8 10 12 14 16 skin desquamation continuous 0 Outcome measures (small flakes) but no awareness Key inclusion criteria fissure formation Although the increase in dryness was small, the adjunctive use of a -10 moisturizer was effective in helping to prevent it. Importantly, this • Investigator ratings: 4 Severe Severe Severe Marked Prominent 2 Mild • Mild to moderate facial acne vulgaris, defined as: Easily noted dryness Extensive Beet red Definite discomfort and dense enhancement in the tolerability of tazarotene 0.1% cream was achieved – Mean Inflammatory lesion count (papules plus pustules) with accentuation peeling coloration causing continuous Mean -20 erythema