Treatment Compatible Cosmetics

Topically applied tretinoin (a retinoid) has been used for over 25 years to treat acne and disorders of keratinization. Now, tretinoin emollient cream, 0.05% (Renova®), may be prescribed for the treatment of photodamaged and chronologically aged skin, in conjunction with appropriate skin care and sun protection routines. Mild to moderate cutaneous side effects to topical tretinoin, such as xerosis, peeling, erythema and subjective irritation, are experienced by a majority of patients undergoing retinoid therapy. Results of clinical compatibility testing show that concomitant use of effective moisturizers, mild cleansers and daily sunscreens greatly enhance skin tolerance and patient comfort. A frequently prescribed regimen for topical treatment of photodamaged skin includes a combination of tretinoin and glycolic acid. While many clinicians report the use of both these agents for the management of their patients, little information exists in the literature about their compatibility in concomitant use. The results of a double-blind clinical study demonstrate that daytime usage of one of two 8% glycolic acid lotions in addition to nightly applications of Renova was well tolerated as part of a comprehensive skin care and sun protection program. Topically applied retinoic acid (tretinoin) has been used for over 25 years to effectively treat acne and keratinization disorders. More recently, a tretinoin emollient cream (Renova®) has been approved for treatment of photodamage and chronologically aged skin. Despite the long and effective track record of retinoic acid, the irritation intolerance (xerosis, peeling, erythema and subjective irritation) associated with this treatment is still an issue [1]. Often, depending on the degree of photodamage and patient expectations, other treatment modalities are combined with retinoid treatment, which can compound this issue. One frequently prescribed topical treatment regimen includes a combination of tretinoin and glycolic acid [2]. While many clinicians report the use of both agents for improvWash out phase (weeks 1 + 2) 112 Skin Pharmacol Appl Skin Physiol 1999;12:111–119 Appa Table 1. Study 1: design for the Renova compatibility study Test regimen (Neutrogena) Control regimen (subject’s own product) Day cleanser day moisturizer SPF 15 supplemental sunscreen (TiO2) (if outdoors for over 1 h) cleanser moisturizer sunscreen (minimum SPF 15) Night cleanser moisturizer cleanser moisturizer Treatment phase (weeks 1–8) Day cleanser day moisturizer SPF 15 supplemental sunscreen (TiO2) (if outdoors for over 1 h) cleanser moisturizer sunscreen (minimum SPF 15) Night cleanser tretinoin (0.05%) cream night cream cleanser tretinoin (0.05%) cream moisturizer ing photodamage, there is little information in the literature about their compatibility in concomitant use. The paper outlines two studies which demonstrate that retinoic acid dermatitis can be ameliorated by consistent use of appropriate adjunctive cosmetic products, and that excellent skin tolerance can be achieved during concomitant AHA/retinoid therapy by adherence to a comprehensive skin care and standard sun avoidance program. The first study assesses the compatibility of a facial cosmetic regimen with subjects undergoing Renova therapy for photodamage relative to a control group using their own products. Compatibility was determined by demonstrating that the test regimen does not increase the incidence or intensity of dermatitis associated with retinoid therapy. The second study assesses the compatibility of two glycolic acid lotions with Renova treatment similarly in comparison to a comprehensive skin care regimen without glycolic acid. Materials and Methods Study No. 1: Renova Compatibility Fifty-nine female subjects, age 30–55 years, with Fitzpatrick skin types I–III and mild to moderate photodamaged facial skin (Glogau classification I and II) participated in a double-blind, randomized, controlled clinical study. Subjects were assigned to one of two groups. One group used their own facial care (cleansing, moisturizing) regimen (n = 28), while the remaining group was assigned a test regimen (n = 31) detailed below. All subjects were assigned Renova (0.05% tretinoin emollient cream) for nightly use. The study consisted of a washout phase and a treatment phase, as detailed in table 1. In order to qualify for this study, subjects did not use topical retinoids for at least 3 months and systemic retinoids for more than 6 months prior to the start of the study. Test Regimen. Subjects assigned to the test regimen used four blind-labeled Neutrogena products designed for use with tretinoin therapy. The regimen consisted of an ultra-mild, soap-free cleanser based on an acyl glutamate surfactant system (Neutrogena® Non-Drying Cleanser), a daily moisturizing lotion with UVA and UVB sunscreen (Neutrogena Moisture SPF 15), a night cream (Neutrogena Light Night Cream) and a titanium dioxide sunscreen (Neutrogena Sensitive Wash out phase (weeks 1 + 2) Retinoid Therapy: Compatible Skin Care Skin Pharmacol Appl Skin Physiol 1999;12:111–119 113 Table 2. Study 2: design for the concomitant Renova and glycolic acid therapy study Test regimen 1 Test regimen 2 Control regimen Day cleanser glycolic acid lotion SPF 15 supplemental sunscreen (TiO2) (if outdoors for over 1 h) cleanser glycolic acid lotion day moisturizer SPF 15 supplemental sunscreen (TiO2) (if outdoors for over 1 h) cleanser day moisturizer SPF 15 supplemental sunscreen (TiO2) (if outdoors for over 1 h) Night cleanser night cream cleanser night cream cleanser night cream Treatment phase (weeks 1–8) Day cleanser glycolic acid lotion SPF 15 supplemental sunscreen (TiO2) (if outdoors for over 1 h) cleanser glycolic acid lotion day moisturizer SPF 15 supplemental sunscreen (TiO2) (if outdoors for over 1 h) cleanser day moisturizer SPF 15 supplemental sunscreen (TiO2) (if outdoors for over 1 h) Night cleanser tretinoin (0.05%) cream night cream cleanser tretinoin (0.05%) cream night cream cleanser tretinoin (0.05%) cream night cream Skin Sunblock 17) for use during periods of sun exposure greater than 60 min. Evaluations. Subjective (erythema, edema, scaling) and objective (pruritus, burning/stinging, tightness) measures of irritation were evaluated at weeks 0, 2, 4, 6 and 8 of the study treatment phase. All irritation parameters were measured on a 5-point scale (0–4), where 0 indicates absence of condition and 4 indicates severe condition. D-Squame® disk sampling was also done at each time point to determine the intensity and extent of skin scaling. Study No. 2: Concomitant Renova and Glycolic Acid Therapy Subjects were recruited according to the same criteria as study No. 1. Ninety-nine female subjects participated in the clinical study, which was of a doubleblind, randomized, controlled design. Subjects were assigned to one of three groups. One group (n = 32), designated as the control, was assigned the four blindlabeled Neutrogena products used in study No. 1. The second group (n = 33) used, in addition to the cleanser, night cream and the titanium dioxide sunscreen from the aforementioned regimen, an 8% glycolic acid face lotion (pH 3.5) with UVA and UVB sunscreens (SPF 15) and antioxidants. The third group (n = 34) used the main four-product regimen and an 8% glycolic acid face lotion (pH 3.5, without sunscreen) with antioxidants. All subjects applied Renova (0.05% tretinoin emollient cream) nightly. Similar to study No. 1, this study incorporated a preconditioning phase and a treatment phase (table 2). Both glycolic acid products were previously established to be clinically safe and effective in improving the appearance of photodamage [data on file]. Objective and subjective irritation evaluations, as described in study No. 1, along with DSquame sampling, was performed at weeks 0, 2 and 4 of the study treatment phase. Results and Discussion Study No. 1: Renova Compatibility Dermatologist (objective) evaluation of irritation showed only minor and sporadic signs of irritation equivalently for both treatment groups. A greater frequency of subjective irritation symptoms was reported for the control group as compared to the test regimen group. As in previously published Renova studies [3, 4], most measures of irritation peaked within the first 2 weeks of treatment (fig. 1, 2). D-Squame disk analysis showed that fine flaking increased significantly, indicative of increased cell turnover, compared to baseline for both treatments at weeks 4 and 8.