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Topical retinoids are one of the most effective classes of topical drugs used to treat acne vulgaris. The effects of the gel formulation of the topical retinoid tazarotene have been widely reported, but few data on the cream formulation are available.The primary aim of the 2 studies reported in this article was to determine the effects of tazarotene 0.1 % cream in patients with facial acne vulgaris.Two randomized, double-blind, parallel-group studies were performed. The first was conducted at 14 investigational sites across the United States, and the second took place at 15 sites, with 5 of these providing blood samples for analysis of tazarotenic acid. In both studies, patients agedor =12 years with facial acne vulgaris were randomized to receive tazarotene or vehicle cream QD for 12 weeks. Lesion counts (noninflammatory, inflammatory, and total) and overall clinical and global assessments were made at weeks 0 (baseline), 4, 8, and 12. Adverse events (AEs) were monitored throughout the study In one of the studies, therapeutic drug monitoring was performed at weeks 4 and 8 in members of the study population who gave consent for blood withdrawal.Eight hundred forty-seven patients were enrolled in the 2 studies (430 males, 417 females; mean age,19 years; age range, 11-52 years [1 patient was entered into the study at age 11 years, in violation of the protocol]). At 12 weeks, the median percentage changes from baseline in all 3 lesion counts were significantly lower with tazarotene than with vehicle (all, P0.001), as were the overall clinical and global responses (both, P0.001). Treatment-related AEs whose incidence was higher with tazarotene than with vehicle included desquamation, dry skin, erythema, a burning sensation on the skin, and skin irritation (all, P0.001) and pruritus (P0.01); most (83%-98%) were mild or moderate. Systemic exposure to tazarotenic acid was limited (mean,0.1 ng/mL) and did not increase with time.In these 2 studies in adolescent and adult patients with facial acne vulgaris, tazarotene 0.1%cream QD for 12 weeks was effective and well tolerated. Systemic exposure to tazarotenic acid was limited.

Background: Tazarotene in a gel formulation is widely used in the treatment of psoriasis. Objective: To determine the efficacy and safety of tazarotene 0.1% and 0.05% creams in the treatment of psoriasis. Methods: A total of 1303 patients participated in 2 clinical trials. Patients applied tazarotene creams 0.1% and 0.05% or vehicle once daily to all psoriatic lesions for 12 weeks followed by a 12-week posttreatment period. Results: Both creams were significantly more effective than vehicle on the basis of an overall assessment of psoriasis, a global response to treatment, and reduction in plaque elevation and scaling. Therapeutic effect was maintained during the posttreatment period. Common adverse events included signs and symptoms of skin irritation. Conclusion: Tazarotene creams were associated with significant reductions in the severity of the clinical signs of psoriasis and were found to be safe with acceptable tolerability. Tazarotene cream 0.1% was generally more effective, although slightly less well tolerated, than the 0.05% cream. (J Am Acad Dermatol 2003;48:760-7.)

Background: Tazarotene, a potent acetylenic retinoid for topical use, might be expected to benefit photodamaged skin, including improving the classical signs of fine wrinkles, mottled hyperpigmentation, and roughness. Objective: Our purpose was to determine the efficacy and safety of tazarotene 0.1% gel in the treatment of photodamaged dorsal forearm skin. Methods: Ten healthy female volunteers, aged 45 to 65 years, with moderately photodamaged forearm skin applied tazarotene 0.1% gel to one arm and vehicle gel to the other once daily for 12 weeks. The study was a double-blind, randomized, paired-comparison evaluation conducted at a single site. Results: Tazarotene showed beneficial effects for several efficacy variables. It was more efficacious than vehicle in reducing skin roughness and fine wrinkling based on objective measurements. Tazarotene also corrected epidermal atrophy and atypia and improved skin hydration properties. Conclusion: In this 12-week pilot study tazarotene redressed abnormalities associated with photo-damaged skin. (J Am Acad Dermatol 2000;43:656-63.)

Topical therapy providing initial improvement and maintenance of effect after treatment of the large majority of patients with limited, mild to moderate psoriasis is not presently available. Previous topical retinoids have generally been either ineffective or too irritating for therapy of psoriasis.Our purpose was to evaluate a new topical retinoid, tazarotene, in the treatment of stable plaque psoriasis during treatment and posttreatment periods.In a double-blind manner, 324 patients were randomly selected to receive tazarotene 0.1% or 0.05% gel, or vehicle control, once daily for 12 weeks and were then followed up for 12 weeks after treatment.Of the total, 318 patients could be evaluated. Tazarotene gels were superior (p0.05) to vehicle, often as early as treatment week 1, in all efficacy measures: plaque elevation, scaling, and erythema; treatment response; percentage treatment success (patients withor = 50% improvement); and time to initial success. Efficacy was equivalent on target lesion sites (trunk or limbs and knees or elbows) and overall. A sustained therapeutic effect was observed for 12 weeks after treatment. Tazarotene gel was cosmetically acceptable. There was low systemic absorption, limiting toxicity to local irritation.Once-daily tazarotene was effective and safe as a topical monotherapy for plaque psoriasis, providing rapid reduction of signs and symptoms.

Background Previous studies indicate that tazarotene is efficacious in reducing signs of photodamage. Objective We sought to confirm the efficacy and tolerability of tazarotene 0.1% cream in the treatment of facial photodamage. Methods A total of 568 patients with at least moderate fine wrinkling or mottled hyperpigmentation applied tazarotene 0.1% cream or vehicle cream to their face once daily for 24 weeks. Results Tazarotene cream was significantly more effective than vehicle in reducing fine wrinkles, mottled hyperpigmentation, lentigines, irregular depigmentation, apparent pore size, elastosis, tactile roughness, and an overall integrated assessment of photodamage. Significance was achieved as early as week 2 for some parameters and had not plateaued by week 24. The majority of patients reported improvements in their photodamage as early as week 4. Adverse events were predominantly mild or moderate signs or symptoms of skin irritation. Conclusion Once-daily tazarotene 0.1% cream is effective in ameliorating multiple signs of facial photodamage.

Objective: To evaluate the safety and pharmacokinetics of tazarotene cream 0.1% under standard (face only) or exaggerated (15% body surface area, including the face) application conditions after a single dose and after repeat topical applications once daily to patients with acne vulgaris or photodamaged skin. Methods: Two separate, randomised, single-centre, nonblinded, parallel-group pharmacokinetic studies were conducted. In one study, tazarotene cream 0.1% was applied either to the face of eight female patients with moderate acne or to 15% body surface area of ten female patients with severe acne. In the other study, tazarotene cream 0.1% was applied either to the face (six females, two males) or to 15% body surface area (8 females, 8 males) of patients with photodamaged skin. In both studies, tazarotene cream 0.1% was applied once daily (except on days 1 and 2) for 30 days. Blood was drawn for measurement of plasma concentrations of tazarotenic acid at defined time intervals after application of the cream. Plasma tazarotenic acid concentrations were determined by a validated gas chromatography-tandem mass spectrometry method with a lower limit of quantification of 0.005 μg/L. Results: At exaggerated application rates in patients with acne vulgaris, the maximum average peak concentration (Cmax) and 24-hour area under the concentration-time curve (AUC) values of tazarotenic acid were (mean ± SD) 1.20 ± 0.41 μg/L (n = 10) and 17.0 ± 6.1 μg · h/L (n = 10), respectively, and occurred on day 15. The single highest Cmax was 1.91 μg/L. At standard application rates in patients with acne vulgaris, the maximum average Cmax and AUC values of tazarotenic acid were 0.10 ± 0.06 μg/L (n = 8) and 1.54 ± 1.01 μg · h/L (n = 8), respectively, and occurred on day 15. At exaggerated application rates in patients with photodamaged skin, the maximum average Cmax and AUC values of tazarotenic acid were (mean ± SD) 1.75 ± 0.53 μg/L (n = 16) and 23.8 ± 7.0 μg · h/L (n = 16), respectively, and occurred on day 22. The single highest Cmax was 3.43 μg/L on day 29. At standard application rates in patients with photodamaged skin, the maximum average Cmax and AUC values of tazarotenic acid were 0.236 ± 0.255 μg/L (n = 8) and 2.44 ± 1.38 μg · h/L (n = 8), respectively, and occurred on day 15. Gender had no influence on the systemic exposure of tazarotenic acid. The most common treatment-related adverse events were signs and symptoms of local irritation, of mild or moderate severity. Conclusion: The pharmacokinetics of tazarotene cream 0.1% in patients with acne vulgaris or photodamaged skin are similar. The maximum average plasma concentrations of tazarotenic acid after topical application of tazarotene cream 0.1% to the face were less than 0.25 μg/L. The maximum average plasma concentrations of tazarotenic acid following application to an exaggerated body surface area (15%) were less than 1.8 μg/L.

To determine the efficacy and safety of 0.1% tazarotene cream for the treatment of photodamage.A 24-week multicenter, double-blind, randomized, vehicle-controlled intervention study followed by a 28-week open-label extension.Ambulatory patients in private and institutional practice.Of 563 patients with facial photodamage, 91% and 86% completed the double-blind and open-label phases, respectively. In the double-blind phase, 20 of 283 tazarotene-treated patients and 1 of 280 vehicle-treated patients discontinued treatment owing to adverse events.Once-daily application of 0.1% tazarotene cream or nonmedicated vehicle cream to the face for 24 weeks. Then, all continuing patients received treatment with 0.1% tazarotene cream for another 28 weeks.Primarily, fine wrinkling and mottled hyperpigmentation. Also, lentigines, elastosis, pore size, irregular depigmentation, tactile roughness, coarse wrinkling, telangiectasia, actinic keratoses, overall integrated assessment of photodamage, global response to treatment, patients' overall assessment of photodamage, and plasma levels of tazarotenic acid.Compared with the vehicle, at week 24 tazarotene resulted in a significantly greater incidence of patients achieving treatment success (or=50% global improvement) and at least a 1-grade improvement in fine wrinkling, mottled hyperpigmentation, lentigines, elastosis, pore size, irregular depigmentation, tactile roughness, coarse wrinkling, and the overall integrated assessment of photodamage (P.01). Additional clinical improvement occurred with continued tazarotene treatment and had not plateaued by week 52. Plasma tazarotenic acid concentrations did not exceed 0.71 ng/mL.Once-daily applications of 0.1% tazarotene cream significantly reduced multiple signs of photodamage. Plasma levels of tazarotenic acid remained below those of endogenous retinoids.

Objective To assess the safety and efficacy of 4 concentrations of tazarotene cream in the treatment of facial photodamage. Design Prospective weekly multicenter, investigator-masked, randomized, parallel-group study. Setting University hospitals and clinical research centers. Patients Three hundred forty-nine subjects with facial photodamage. Intervention Daily topical application of tazarotene cream (0.01%, 0.025%, 0.05%, and 0.1%) compared with its vehicle and with 0.05% tretinoin emollient cream. Results Tazarotene cream and tretinoin cream significantly improved mottled hyperpigmentation and fine wrinkles. At week 24, treatment success rates based on global responses were 67% (39 of 58 subjects) with 0.1% tazarotene, 52% (30 of 58 subjects) with 0.05% tazarotene, 36% (21 of 58 subjects) with 0.025% tazarotene, 41% (24 of 59 subjects) with 0.01% tazarotene, 55% (32 of 58 subjects) with 0.05% tretinoin, and 22% (13 of 58 subjects) with vehicle. Local adverse events, although more frequent with tazarotene at higher concentrations, were generally mild to moderate. Conclusions Tazarotene in a cream formulation is safe and is associated with positive changes in the treatment of photodamaged facial skin.

Background Repeated applications of a corticosteroid can induce epidermal atrophy. This study was performed to investigate whether the adjunctive use of tazarotene gel 0.1% might help to minimize the development of steroid-induced epidermal atrophy. Methods Each of 24 healthy volunteers received the following six treatments (applied 6 days per week for 4 weeks), which were randomized to each of six sites on their forearms: no treatment, tazarotene vehicle, tazarotene vehicle + tazarotene gel 0.1%, diflorasone diacetate 0.05% ointment, diflorasone diacetate 0.05% ointment + tazarotene vehicle, or diflorasone diacetate 0.05% ointment + tazarotene gel 0.1%. Results The mean epidermal thickness was increased by 20% (NS) and 62% (P ≤ 0.0005) after applications of tazarotene vehicle and tazarotene gel 0.1%, respectively. Application of diflorasone diacetate reduced the mean epidermal thickness by 43% (P ≤ 0.0005). Concomitant application of tazarotene gel 0.1% with diflorasone diacetate did not entirely prevent atrophy, but was shown to ameliorate 37% of the epidermal atrophy induced by diflorasone diacetate alone (P ≤ 0.003 compared with steroid monotherapy). Conclusions Tazarotene gel 0.1% significantly reduces epidermal atrophy induced by diflorasone diacetate 0.05% ointment.

chenoid infiltrate of lymphocytes. Immunofluorescence examination of a perivesicular papule was characterized by numerous ovoid bodies scattered in the papillary dermis. These stained for IgM, IgG, and fibrinogen. IgG, C3, and fibrinogen were also deposited linearly along the dermoepidermal junction. Immunofluorescence studies on normal-appearing skin showed a strong linear band of IgG and C3 at the dermoepidermal junction without staining of colloid bodies. Serum and blister fluid were positive at a titer of 1:80 for basement membrane zone (BMZ) antibodies. A diagnosis ofLPP was made. She was initially treated with prednisone, 40 mg daily (1.5 mg/kg/day), with a good response, no new vesicles appeared and the papular lesions cleared. After 2 weeks circulating BMZ antibodies decreased to a titer of 1:20. The dosage of prednisone was reduced to 20 mg daily for 14 days and then discontinued. Topical fluorinated corticoids were administered for an additional month. At that time she had resolution of all lesions. Two months later, she had a relapse of LP, without blistering, on both ankles. At the time of relapse circulating BMZ antibodies were absent.

Background: The addition of oral retinoids to phototherapy may accelerate and enhance antipsoriatic efficacy, but can result in systemic adverse events and additional laboratory monitoring costs. Objective: Our purpose was to determine whether the topical addition of tazarotene to UVB phototherapy improves efficacy without problems related to photosensitivity. Methods: Bilateral target plaques were randomized to receive two of the following, one on each plaque once daily for 14 days: tazarotene 0.1% gel, vehicle gel, or no treatment. Thereafter, the same treatments were continued 3 times per week, plus UVB phototherapy 3 times per week, for an additional 67 days. Results: Tazarotene plus UVB phototherapy achieved faster and significantly greater reductions in plaque elevation and scaling throughout treatment and achieved at least 50% improvement from the pretreatment baseline with a significantly lower median cumulative UVB exposure than vehicle gel plus UVB light or UVB phototherapy alone. No case of unusual photosensitivity was noted in the tazarotene plus UVB treatment group. Conclusion: The addition of tazarotene to UVB phototherapy improves and accelerates efficacy and maintains acceptable safety and tolerability. (J Am Acad Dermatol 2000;43:821-8.)

Background: Topical corticosteroids are often used in the treatment of psoriasis, but long-term use may be associated with serious adverse events such as tachyphylaxis or atrophy of the skin. Tazarotene, a new topical retinoid, has demonstrated significant clinical benefits but can cause mild to moderate local irritation. Objective: We evaluate whether a combination treatment of topical tazarotene and a topical corticosteroid would increase efficacy while reducing the incidence of local adverse events associated with a topical retinoid. Methods: Three hundred patients enrolled in an investigator-masked study were randomly assigned to 1 of 4 treatment groups: tazarotene 0.1% gel in combination with placebo cream, or with a low-, mid-, or high-potency corticosteroid cream, for 12 weeks of treatment and a posttreatment follow-up at week 16. Results: Tazarotene 0.1% gel in combination with a mid- or high-potency corticosteroid, when compared with tazarotene plus placebo cream, achieved significantly greater reductions in scaling, erythema, and overall lesional severity, and a decreased incidence of adverse events. Conclusion: All tazarotene combinations (including tazarotene plus placebo) were highly effective in rapidly reducing the severity of psoriasis. Combining tazarotene with a topical corticosteroid increased efficacy while reducing the incidence of local adverse events. (J Am Acad Dermatol 1998;39:590-6.)

Background: A new class of topical receptor-selective acetylenic retinoids, the first of which is tazarotene, has been developed. Objective: Our purpose was to compare the safety, efficacy, and duration of therapeutic effect of 12 weeks of once-daily tazarotene 0.1% and 0.05% gel with that of twice-daily fluocinonide 0.05% cream in the treatment of patients with plaque psoriasis. Methods: Three hundred forty-eight patients with plaque psoriasis were enrolled and 275 patients completed a multicenter, investigator-masked, randomized, parallel-group clinical trial. Results: Both tazarotene gels were as effective as fluocinonide in reducing plaque elevation after 1 week of treatment, and tazarotene 0.1% gel was similar to fluocinonide in reducing scaling of trunk/limb lesions at all study weeks except week 4. Tazarotene 0.1% gel was similar to fluocinonide in reducing scaling of knee/elbow lesions at weeks 8 and 12. Fluocinonide had a significantly greater effect on erythema than tazarotene at weeks 2 through 8. However, treatments were not significantly different at week 12, and tazarotene demonstrated significantly better maintenance of therapeutic effect after cessation of therapy. Conclusion: Tazarotene 0.1% and 0.05% gels were safe and effective in the treatment of mild-to-moderate plaque psoriasis.(J Am Acad Dermatol 1998;38:705-11.)

Dosage forms of sodium {4-[5-Methoxy-2-(4-methoxy-3,5-dimethyl-pyridin-2-ylmethanesulfinyl)-benzoimidazole-1-sulfonyl]-phenoxy}-acetate, and methods of use of the dosage forms are disclosed herein.

Background: Oral retinoids have been widely used in psoriasis, but topical forms have been ineffective or irritating. Objective: Our purpose was to determine the clinical and molecular effects of a new topical retinoid, AGN 190168, on psoriasis. Methods: Seven patients with psoriasis were treated for 2 weeks with topical retinoid and 2 weeks with vehicle. Two control subjects with psoriasis were treated for 2 weeks with vehicle alone. Biopsy specimens from normal skin as well as from untreated and treated psoriatic lesions were compared by immunohistochemical analysis. Differentiation and inflammatory markers were studied. Results: Clinical improvement was seen in all seven patients after 2 weeks of treatment. Improvement was still present, but not significant, after 2 additional weeks of vehicle application. Histologic examination showed a return to a more normal morphology in four of seven biopsy specimens, which correlated with filaggrin expression. There was a diminution in the precocious expression of keratinocyte transglutaminase, keratin 16, and involucrin, as well as a decrease in epidermal growth factor receptor and in the number of cells expressing intercellular adhesion molecule type 1 and HLA-DR. Conclusion: Clinical and histologic improvements were seen in psoriasis in association with the topical application of AGN 190168 at 2 weeks, including decreased inflammation and restoration of normal epidermal differentiation. Small patient numbers and the possibility that the changes were related to clinical improvement alone and not the topical agent preclude definitive conclusions.

Seventy patients with tinea cruris or tinea corporis were treated with naftifine cream 1% or vehicle once daily for 4 weeks in this double-blind, randomized study. After two weeks, the patients using naftifine had a significantly higher mycologic cure rate than the vehicle-treated patients (79% vs. 31%, p less than 0.001), and they showed significantly better resolution of signs and symptoms. Statistically significantly differences favoring naftifine over its vehicle were found throughout the treatment period and 2 weeks posttreatment.

Oral tazarotene has been shown to be highly effective for the treatment of moderate to very severe plaque psoriasis, significantly improving plaque elevation, scaling, erythema, and percentage body surface area involvement. As psoriasis is a chronic disease, the duration of clinical improvement obtained is of great importance to patients. Combined data from two 6-month multicenter, double-blind, randomized, placebo-controlled trials show that the clinical and statistical superiority of oral tazarotene (4.5 mg once daily) over placebo is maintained for at least 12 weeks post-treatment. The incidence of patients achieving 50% global improvement was 54% with tazarotene (15% with placebo) at the end of the 12-week treatment phase, with only a modest decline to 43% (12% with placebo) at the end of the 12-week follow-up phase. Thus, the incidence of tazarotenetreated patients with 50% global improvement after the 12-week follow-up phase was approximately 80% of the incidence after the 12-week treatment phase. The primary efficacy variable, clinical success, was defined as a 2-grade improvement in Overall Lesional Assessment (graded as none, minimal, mild, moderate, severe, or very severe). The incidence of patients achieving clinical success was 28% with tazarotene (6% with placebo) at the end of the 12-week treatment phase. Thus, the incidence of tazarotene-treated patients with clinical success after the 12-week follow-up phase was approximately 81% of the incidence after the 12-week treatment phase. Plaque elevation, scaling, and erythema were graded as 0 (none), 1 (mild), 2 (moderate), 3 (severe), or 4 (very severe). With tazarotene, the mean score for each of these parameters was reduced by a grade of 0.9, 0.9, and 0.8, respectively, at the end of the 12-week treatment phase, and 0.7, 0.7, and 0.7, respectively at the end of the 12-week follow-up phase. (The equivalent reductions with placebo were 0.3, 0.3, and 0.2, respectively at the end of the treatment phase and 0.2, 0.2, and 0.2 at the end of the post-treatment phase.) Thus, approximately 78 to 88% of the mean improvements in plaque elevation, scaling, and erythema attained with tazarotene treatment were maintained for at least 12 weeks post-treatment. The data suggest that even 12 weeks post-treatment the effect of oral tazarotene is maintained at approximately 80% of the level of clinical improvement obtained after 12 weeks of treatment.

To determine the safety and efficacy of topically applied tazarotene gel in the treatment of mild to moderate psoriatic plaques.Two multicenter, double-blind, randomized studies of 6- and 8-week duration, with an 8-week follow-up in the second study.Medical center outpatient dermatology services.One hundred fifty-three adults with 2 bilateral target plaques on the trunk, legs, or arms.Vehicle gel or 0.01% and 0.05% tazarotene gel administered twice daily to 45 patients (study A), or 0.05% and 0.1% tazarotene gel administered either once or twice daily to 108 patients (study B).Treatment success and plaque elevation, scaling, and erythema vs time.The 0.01% tazarotene gel showed minimal efficacy. Applications of 0.05% and 0.1% tazarotene gels administered once or twice daily, resulted in significant improvements in plaque elevation, scaling, erythema, and overall clinical severity as early as 1 week. Treatment success rates (defined as75% improvement from baseline) were 45% with 0.05% tazarotene gel vs 13% with vehicle gel after 6 weeks of treatment (P.05; study A) and ranged from 48% to 63% with the various tazarotene treatment regimens after 8 weeks of treatment (study B). These improvements were evident at the 8-week follow-up. Treatment-related adverse effects were generally limited to mild or moderate local irritation and were less frequent with the treatment regimen administered once daily.The 0.05% and 0.1% tazarotene gels demonstrated significant efficacy in the treatment of mild to moderate psoriatic plaques that persisted after cessation of treatment.

A double-blind parallel group study was undertaken to assess the effect of adding a topically applied corticosteroid cream to a modified Goeckerman regimen to treat patients with psoriasis. Nineteen patients with psoriasis were treated with either this regimen and hydrocortisone valerate cream or the regimen and vehicle cream. Patients were given daily treatments until their skin cleared or until twenty-eight treatments were received. They were then followed up until rebound or relapse occurred or 6 months had passed. The addition of hydrocortisone valerate cream to the modified Goeckerman regimen led to relapse after 5.9 weeks in comparison with 17.9 weeks for the control group.

Data from 104 subjects with tinea cruris or tinea corporis were evaluated in this double-blind, randomized study. The subjects applied naftifine cream 1% or econazole nitrate cream 1% to affected areas twice daily for 4 weeks. After 1 week of treatment naftifine had an overall cure rate of 19% compared with 4% for econazole (p = 0.03). A difference in favor of naftifine, although not statistically significant after the first week, persisted throughout treatment. Two weeks after the end of treatment both medications had overall cure rates of approximately 80%. Three percent of the naftifine-treated subjects had side effects compared with 13% of the econazole-treated subjects. In two subjects using econazole, the side effects were severe enough to warrant discontinuation of treatment.

The efficacy of a sunscreen containing an investigational drug, butyl methoxydibenzoylmethane in combination with padimate O against the erythemogenic effect of ultraviolet A (UVA) radiation was evaluated in two double-blind studies involving subjects sensitized with topical 8-methoxypsoralen. UVA radiation was supplied from either a filtered solar simulator (indoors) or filtered sunlight (outdoors). Five formulations were tested: (1) 3% butyl methoxydibenzoylmethane and 7% padimate O, (2) 7% padimate O, 5% octyl salicylate, and 3% oxybenzone, (3) 3% butyl methoxydibenzoylmethane alone, (4) 7% padimate O alone, and (5) vehicle. Sunscreen protection against the erythemogenic effect of UVA radiation was expressed as phototoxic protection factors. The phototoxic protection factor for each sunscreen was derived from a ratio of the minimal phototoxic dose of UVA radiation that produced delayed erythema on sunscreen-protected and unprotected skin. The combination of 3% butyl methoxydibenzoylmethane and 7% padimate O provided significantly greater protection than the other sunscreen formulations, and for each sunscreen the phototoxic protection factors determined indoors and outdoors were comparable.

One hundred two patients with mild to moderate facial acne vulgaris completed a 12-week, investigator-masked, randomized, parallel-group comparison of a gel formulation of erythromycin (2%) with clindamycin phosphate 1 % solution. Patients were evaluated at a baseline visit and after 4, 8, and 12 weeks of twice-daily treatment. Both medications significantly reduced the numbers of papules and open and closed comedones. No significant differences in lesion count reductions were detected between the treatment groups after 8 and 12 weeks of treatment. By the end of 12 weeks, 48% of the patients in the erythromycin group and 47% in the clindamycin group had good or excellent responses to treatment. No patient was terminated from the study for side effects. Most patients, 65% in the erythromycin 2% gel group and 67% in the clindamycin phosphate 1% solution group, had a favorable impression of the overall cosmetic characteristics of their study medication.