Tazarotene cream or gel is used topically in the management of stable plaque psoriasis. In 4 large, vehicle-controlled studies, 12 weeks of therapy with tazarotene 0.05 or 0.1% cream or gel resulted in substantial reductions in the severity of erythema, scaling, and plaque elevation with improvement noted as early as 1-2 weeks in some patients. In 2 of the studies, treatment effects were sustained for up to 12 weeks in approximately 30 or 50% of patients after discontinuance of tazarotene cream or gel, respectively. In these 4 studies, tazarotene 0.1% cream or gel was more effective than 0.05% cream or gel in improving manifestations associated with psoriasis, but the 0.05% cream or gel was associated with less local irritation.
Data from a phase III comparative trial indicate similar reductions from baseline in the severity of psoriatic lesions in patients receiving 12 weeks of therapy with tazarotene 0.05 or 0.1% gel versus topical fluocinonide 0.05% cream. In this study, while topical fluocinonide was more effective than topical tazarotene in reducing erythema during the treatment period, the likelihood of relapse during the 12-week period following discontinuance of treatment was less with tazarotene 0.1% gel than with fluocinonide 0.05% cream. Additional controlled, comparative studies are needed to establish the relative efficacy of topical tazarotene and other currently available topical agents used in the management of psoriasis.
Combined therapy consisting of tazarotene and a mid- or high-potency topical corticosteroid is more effective than therapy with either agent alone. In several studies in patients with plaque psoriasis, such combined therapy was associated with a more rapid response, a higher rate of treatment success (i.e., global improvement of at least 50%), and a longer remission period compared with monotherapy.
Tazarotene 0.1% cream or gel is used topically for the treatment of mild to moderate facial acne vulgaris. In controlled studies, tazarotene 0.1% cream or gel was more effective than vehicle in reducing the number of inflammatory and noninflammatory lesions as well as the total number of lesions.
Data from several randomized, double-blind, comparative studies indicate that tazarotene 0.1% gel may be more effective than adapalene or tretinoin gel in the treatment of mild to moderate facial acne vulgaris. In 2 randomized, double-blind, comparative studies in patients with mild to moderate facial acne vulgaris, therapy with tazarotene 0.1% gel for up to 12 weeks was associated with a higher rate of treatment success (i.e., global improvement of at least 50%), greater reductions in overall disease severity, and greater reductions in the number of noninflammatory lesions compared with therapy with adapalene 0.1% gel or tretinoin 0.1% gel containing microspheres; tazarotene 0.1% gel also was more effective than adapalene 0.1% gel in reducing the number of inflammatory lesions. In another randomized, double-blind, comparative study, tazarotene 0.1% gel was more effective than tretinoin 0.025% gel in reducing the number of open comedones and noninflammatory lesions. Although a higher incidence of certain adverse effects (e.g., irritation, burning, pruritus, erythema, peeling) was observed in patients receiving tazarotene 0.1% gel than in those receiving adapalene 0.1% or tretinoin 0.025% gel, such difference was transient and is unlikely to be clinically important. Some clinicians state that the tolerability of topical retinoid therapy depends more on skin sensitivity and susceptibility of the patient than on the particular retinoid used.
The manufacturer states that efficacy of tazarotene in the treatment of acne in patients resistant to oral antibiotics or previously treated with other retinoids has not been established.
Tazarotene is used topically as a 0.1% cream for palliative therapy to improve dermatologic changes (e.g., fine wrinkling, mottled hypopigmentation or hyperpigmentation, benign lentigines) associated with photodamage. Topical tazarotene therapy should be used under medical supervision as an adjunct to a comprehensive skin care plan and sun avoidance program that includes the use of effective sunscreens (minimum strength of SPF 15) and protective clothing. Patients should be advised that topical therapy with tazarotene does not eliminate or prevent wrinkles, repair photodamaged skin, reverse photoaging, or restore a more youthful or younger dermal histologic pattern. In addition, it must be noted that topical tazarotene has not demonstrated a mitigating effect on severe manifestations of chronic sunlight exposure (e.g., coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, dermal elastosis). The manufacturer states that safety and efficacy of topical tazarotene therapy for photoaging beyond 52 weeks have not been established.
Improved facial skin appearance, including improvements in fine wrinkles, mottled hypopigmentation or hyperpigmentation, and benign lentigines, has been demonstrated in several double-blind, controlled studies in patients (97% Caucasian) with mild to severe photodamage receiving topical tazarotene therapy for up to 24 weeks. In these studies in which tazarotene 0.1% cream or vehicle was applied to the face, clinical improvement (manifested as at least a 1-point reduction in a 5-point scale of photodamage severity) in fine wrinkling was observed in 40-58% of patients receiving tazarotene cream and in 16-23% of those receiving vehicle. Clinical improvement in mottled hyperpigmentation was observed in 59-82 or 18-40% of patients receiving tazarotene cream or vehicle, respectively. Improvements in mottled hyperpigmentation may be evident as early as 2 weeks following initiation of therapy, while improvements in fine wrinkling may be evident as early as 8 weeks. The duration of the mitigating effects on fine wrinkling, mottled hypopigmentation and hyperpigmentation, and benign lentigines following discontinuance of tazarotene 0.1% cream has not been evaluated.
Limited data suggest that tazarotene 0.1% cream is at least as effective as tretinoin 0.05% cream in improving fine wrinkling and mottled hyperpigmentation associated with photodamage. In a randomized, dose-ranging, comparative study in patients with at least moderate photodamage, therapy with tazarotene 0.1% cream or tretinoin 0.05% cream for approximately 24 weeks was associated with a treatment success (i.e., global improvement of at least 50%) rate of 67 or 55%, respectively. Although the overall improvement rates were not significantly different between the 2 groups, a trend toward a more rapid response was observed in patients receiving tazarotene 0.1% cream.
Safety and efficacy of tazarotene 0.1% cream have not been established in nonwhite patients (e.g., Asian, Hispanic) or in patients with Fitzpatrick skin types V and VI. Safety and efficacy of the drug in the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna also have not been established.