Clobetasol propionate for psoriasis: are ointments really more potent?

BACKGROUND: Clobetasol propionate is the most common topical therapy used for psoriasis in the US. Conventional dermatologic wisdom is that ointment preparations provide the highest potency (due to their occlusive nature and moisturizing ability) and are best suited for psoriasis. However, patients often find application of ointment to be messy, raising concerns about both short-term and long-term adherence to treatment. This article reviews the current literature and assesses the relative potency of clobetasol propionate ointment compared to other clobetasol propionate preparations in the treatment of psoriasis. Relevant literature was identified by PubMed and Google searches. We included studies of psoriasis that reported the percentage of subjects that achieved desired efficacy endpoints, as well as studies that reported the subjects' mean change in symptoms from baseline. We excluded studies conducted before 1980 and those that allowed concomitant treatments. OBSERVATIONS: Efficacy rates ranged from 17% to 80% for the different vehicles: ointment, solution, foam, cream, lotion, shampoo, and emollient. CONCLUSIONS: Clobetasol propionate is a very effective treatment for psoriasis. Ointment preparations have similar efficacy to other preparations in clinical trial situations. In clinical practice, a situation in which patient preferences are more likely to affect compliance, it may be best to choose whichever vehicle patients find preferable.     

Clobetasol propionate emollient formulation foam in the treatment of corticosteroid-responsive dermatoses

Background: Topical corticosteroids are the most common treatment modality for patients with psoriasis and atopic dermatitis; however, the efficacy of topical corticosteroids is often hampered by barriers to patient adherence, such as lack of efficacy, side effects and inconvenience. Recently published studies have investigated the safety and efficacy of a novel emollient foam (EF) formulation of clobetasol propionate (CP), a class I topical corticosteroid in psoriasis and atopic dermatitis. Objectives: To summarize recent literature on CP EF foam, and to evaluate recent Phase II and III clinical trials of CP EF foam in psoriasis and atopic dermatitis. Methods: The MEDLINE (1950 – January 2008) database was searched using the following terms: ‘clobetasol propionate foam’, ‘topical corticosteroids’, ‘topical glucocorticoids’, ‘psoriasis’ and ‘atopic dermatitis’. Results were evaluated for relevance and quality, and additional references were obtained from bibliographies of selected articles. Conclusion: CP EF foam appears to be safe and effective for corticosteroid-responsive dermatoses in adults and children ≥ 12 years of age. As compared to its hydroethanolic foam predecessor, CP EF presents a potential advance for patients who are less likely to tolerate alcohol-based foam. As alcohol-based foams can be irritating and cause stinging in non-hair-bearing areas, this new emollient formulation has the potential to widen the use of CP foam to more patients with atopic dermatitis and to more non-scalp body sites in patients with psoriasis.     

Intermittent application of clobetasol-17-propionate in psoriasis

A double-blind study was carried out in 12 hospitalized patients with symmetrical eruptions of psoriasis to evaluate the effectiveness of treatment with 0.05% clobetasol propionate ointment, applied once daily, to one side for 2 weeks compared with 1 week of active treatment and 1 week of vehicle alone to the other side. The results of clinical assessments of scaling, redness, and induration before and after each week of treatment showed only a very slight difference in favour of 2-weeks' continuous treatment when analyzed using a one-tailed Student's t-test (p = 0.047) but not when two-tailed testing was used (p = 0.094). Although it would appear that there was no clear preference for continuous therapy, other studies involving larger numbers of patients are needed to determine whether intermittent therapy with a potent corticosteroid such as clobetasol propionate is equally as effective in psoriasis.     

Comparison of the response of psoriasis, over a 6-month period, to clobetasol propionate and fluocinolone acetonide ointments.

Twenty-nine patients with bilateral psoriasis were treated with clobetasol propionate ointment on one side of the body and fluocinolone acetonide ointment on the other in a double-blind clinical trial lasting 6 months. With one exception, after the first month of treatment, all patients responded better on the clobetasol propionate treated side. There was a tendency for any relapses to be less rapid and less severe in clobetasol propionate treated lesions. No adverse effects from either steroid were observed.     

Intermittent application of clobet asol-17-propionate in psoriasis

Summary

A double-blind study was carried out in 12 hospitalized patients with symmetrical eruptions of psoriasis to evaluate the efJfectiveness of treatment with 0.05% clobetasol propionate ointment. applied once daily, to one side for 2 weeks compared with 1 week of active treatment and 1 week of vehicle alone to the other side. The results of clinical assessments of scaling, redness, and induration be[ore and utter each week of treatment showed only a very slight difference in favour of 2-weeks' continuous treatment when analyzed using a one-tailed Student's t-test (p = 0.047) but not when two-tailed testing was used (p = 0.094). Although it would appear that there was no clear preference for continuous therapy. other studies involving larger numbers of patients are needed to determine whether intermittent therapy with a potent corticosteroid such as clobetasol propionate is equally as effective in psoriasis.     

Calcipotriene and betamethasone dipropionate for the topical treatment of plaque psoriasis

Introduction: Psoriasis affects an estimated 2% of the world's population, with higher rates in developed countries. 80% have mild-to-moderate disease and 50 to 80% have scalp involvement. Topical treatments are the mainstay of treatment.

Areas covered: Two-compound calcipotriene and betamethasone dipropionate (BD) is a common topical combination therapy consisting of a vitamin D analogue and a corticosteroid. It comes in ointment, gel/suspension, and foam formulations. Phase II and III clinical trials have consistently shown the two-compound formulation to be effective and safe, with no clinically significant skin atrophy, calcium level changes, or adrenal suppression were seen. Topical scalp solution was also safe and effective in treating scalp psoriasis in pediatric populations.

Expert commentary: Calcipotriene plus BD is more effective and safer than the individual ingredients in the same vehicle for treating body and scalp psoriasis. It should be considered a first line therapy for mild-to-moderate plaque psoriasis.     

Comparison of the response of psoriasis,over a 6-month period,to clobetasol propionate and fluocinolone acetonide ointments

Summary

Twenty-nine patients with bilateral psoriasis were treated with clobetasol propionate ointment on one side of the body and fluocinolone acetonide ointment on the other in a double-blind clinical trial lasting 6 months. With one exception, after the first month of treatment, all patients responded better on the clobetasol propionate treated side. There was a tendency for any relapses to be less rapid and less severe in clobetasol propionate treated lesions. No adverse effects from either steroid were observed.     

Short-term safety assessment of clobetasol propionate 0.05% shampoo: hypothalamic-pituitary-adrenal axis suppression, atrophogenicity, and ocular safety in subjects with scalp psoriasis

Clobetasol propionate is known to be a very effective treatment for psoriasis; however, its use is limited by potent corticosteroid class related side effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression and atrophogenicity. The aim of this single-center, parallel group, randomized study was to assess the HPA axis suppression potential, atrophogenicity, and ocular tolerability of clobetasol propionate shampoo in 26 patients with scalp psoriasis. Suitable subjects were treated once daily for 4 weeks with clobetasol propionate shampoo, to be rinsed off after 15 minutes or with a leave-on clobetasol propionate gel. The study demonstrated that clobetasol propionate shampoo did not lead to HPA axis suppression or to skin atrophy. Conversely, the gel led to HPA axis suppression and a decrease in skin thickness. Neither formulation had an impact on ocular safety. Despite the short contact application time, the clobetasol propionate shampoo provides similar efficacy results to the gel.     

Treatment of Hailey-Hailey disease with tacrolimus ointment and clobetasol propionate foam

Hailey-Hailey disease, or familial benign chronic pemphigus, is a chronic disease without a known cure. Current therapeutic strategies attempt to suppress Hailey-Hailey outbreaks and allow the patient to live comfortably with this condition. We have found that applying topical tacrolimus 0.1% ointment (Protopic) twice a day to affected areas is an excellent way to control Hailey-Hailey disease. In addition to effectively controlling Hailey-Hailey outbreaks, tacrolimus is a relatively safe and noninvasive mode of treatment, without significant side effects. We recommend intermittent therapy with clobetasol propionate 0.05% foam (Olux Foam) for patients who break through suppressive therapy with tacrolimus a few times per year. In patients with frequent outbreaks of Hailey-Hailey disease despite suppressive therapy with tacrolimus, we recommend alternating the tacrolimus with clobetasol propionate 0.05% foam every 6 weeks.     

Clobetasol propionate foam in the treatment of psoriasis

Psoriasis is a common, chronic, distressing skin disorder that frequently affects the scalp, skin, nails and joints. Despite treatment, many patients suffer from unremitting disease and decreased quality of life. Scalp-type psoriasis is particularly difficult to treat. Although topical corticosteroids are the mainstay of therapy for moderate-to-severe disease, patients frequently object to the messiness and unfavourable cosmetic appearance of topical treatments. In this context, foam vehicles, which have the advantage of minimal residue and increased ease of application, have emerged as novel alternatives to traditional creams, ointments and solutions. Clobetasol propionate foam 0.05% (OLUX, Connetics Corporation), a high potency topical steroid, has been shown to alleviate symptoms of several dermatological conditions, including scalp and body psoriasis, improve disease severity and increase quality of life. Dose should be limited to 50 g/week, given the risk of adrenal suppression. Because patient preference is an important determinant of medication efficacy in clinical practice, clobetasol foam is a useful new formulation in the treatment of psoriasis and other skin conditions.     

In vivo determination of the skin atrophy potential of the super-high-potency topical corticosteroid fluocinonide 0.1% cream compared with clobetasol propionate 0.05% cream and foam, and a vehicle

PURPOSE: Prolonged topical corticosteroid use is often associated with atrophic skin changes. This trial compared signs of skin atrophy related to 3 super-high-potency corticosteroids: fluocinonide 0.1% cream, clobetasol propionate 0.05% cream, and 0.05% foam. PATIENTS AND METHODS: The test treatments were applied to the forearms 10 females twice daily for 21 days. Skin characteristics were assessed pretreatment and posttreatment for atrophic changes. Further punch biopsies obtained from 5 subjects were assessed histologically. RESULTS: Clobetasol foam produced mild changes in noninvasive tests, but stained skin biopsies revealed structural changes nearly comparable to clobetasol cream, which showed substantial atrophic changes. Fluocinonide cream was the least atrophogenic, producing no or only mild effects that were slightly greater than vehicle. CONCLUSIONS: Fluocinonide cream has a lower potential to produce atrophic changes of the skin than either clobetasol cream or clobetasol propionate foam.     

Clobetasol propionate foam in the treatment of psoriasis

Psoriasis is a common, chronic, distressing skin disorder that frequently affects the scalp, skin, nails and joints. Despite treatment, many patients suffer from unremitting disease and decreased quality of life. Scalp-type psoriasis is particularly difficult to treat. Although topical corticosteroids are the mainstay of therapy for moderate-to-severe disease, patients frequently object to the messiness and unfavourable cosmetic appearance of topical treatments. In this context, foam vehicles, which have the advantage of minimal residue and increased ease of application, have emerged as novel alternatives to traditional creams, ointments and solutions. Clobetasol propionate foam 0.05% (OLUX^?, Connetics Corporation), a high potency topical steroid, has been shown to alleviate symptoms of several dermatological conditions, including scalp and body psoriasis, improve disease severity and increase quality of life. Dose should be limited to 50 g/week, given the risk of adrenal suppression. Because patient preference is an important determinant of medication efficacy in clinical practice, clobetasol foam is a useful new formulation in the treatment of psoriasis and other skin conditions.     

Yin-yang strategy: proposing a new, effective, repeatable, sequential therapy for psoriasis

Psoriasis is a chronic disease that exists in two phases: (1) the acute, flaring phase when psoriasis is highly inflamed, erythematous and pruritic and (2) the chronic, indolent phase after the acute manifestations are brought under control. Ideal therapies for psoriasis must focus on both of these phases. Therefore, a rapid and effective agent must be utilized to treat the acute phase, followed by safe long-term therapy for maintenance. This article proposes a new, effective sequential topical therapy for psoriasis using ongoing treatment with clobetasol (Clobex?) spray for one month followed by calcitriol (Vectical?) ointment for the next month. This strategy provides a highly effective, reliable and safe treatment option with minimal local and systemic adverse risks.     

Calcipotriol. A review of its pharmacological properties and therapeutic use in psoriasis vulgaris.

Calcipotriol (calcipotriene) is a vitamin D3 analogue which inhibits epidermal cell proliferation and enhances cell differentiation. In patients with chronic plaque psoriasis involved in short term studies of 6 to 8 weeks' duration, calcipotriol ointment applied twice daily was significantly more effective than betamethasone valerate and dithranol (anthralin). Pooled data from clinical trials show that calcipotriol is well tolerated, with the majority of adverse events being mild and transient local reactions. Topically applied calcipotriol has low hypercalcaemic potential and, in contrast to topical corticosteroids, oral retinoids and orally administered calcitriol, methotrexate and cyclosporin, calcipotriol does not appear to be associated with a risk of serious adverse events. Thus, at this early stage in its clinical development, calcipotriol appears to be an effective and well tolerated topical therapy for the management of psoriasis; if promising preliminary clinical findings are confirmed, calcipotriol will represent a major advance in this difficult area of therapeutics.     

Treatment of psoriasis and long-term maintenance using 308 nm excimer laser, clobetasol spray, and calcitriol ointment: a case series

Psoriasis is a chronic inflammatory skin disease that is characterized by thickened red plaques covered with silvery scales. Excimer laser therapy is a cutting-edge advancement in UVB phototherapy. In contrast to traditional phototherapy, the 308 nm excimer laser only targets psoriasis plaques, while it spares uninvolved skin. It allows for treatment with a supra-erythmogenic dose of UVB irradiation. Targeted UVB therapy is a possible treatment especially for many who have failed topical treatments, systemic therapy, and traditional phototherapy. For safe and effective psoriasis treatment, a combination of therapies may be used, including a combination of laser treatment with topical medications. We present two cases demonstrating effective treatment with excimer laser in conjunction with clobetasol spray and calcitriol ointment for 12 weeks. Long-term near-clearance of psoriasis was sustained after 6 months and one-year follow up periods without further therapy.     

Clobetasol propionate--where, when, why?

Clobetasol propionate is the most potent of all topical steroids. It is successfully applied in the treatment of various skin diseases such as atopic dermatitis, psoriasis and vulvar lichen sclerosus. The therapy is, however, mainly symptomatic. A preventive effect is only reported in the treatment of the latter. Clobetasol propionate exerts antiinflammatory, immunosuppressive and antimitotic effects influencing the growth, differentiation and function of various cells and inhibiting cytokine production. Seven different dosage forms are available to deliver the drug to the living cells of the skin. Their choice might additionally affect patient compliance. The potency of clobetasol propionate, however, is accompanied by local and systemic side effects, such as skin atrophy and hypothalamic-pituitary-adrenal axis suppression. Patients applying clobetasol propionate must be well instructed in how to use it. Physicians prescribing clobetasol propionate should consider a diversity of factors and be able to answer the questions where, when and why.     

Local treatment of psoriasis of the scalp with clobetasol propionate in alcoholic solution: a day application a comparison of once and twice

Summary

A clinical evaluation was carried out in 53 patients with moderate to severe psoriasis of the scalp to assess the effectiveness of a 0.05 % alcoholic solution of clobetasol propionate. Patients were treated on a non-selective basis with either a once a day or twice a day application. After a 2-weeks' treatment period, the results showed that there was an excellent or good response in 65 % of patients treated once a day and in all of the patients on twice daily application of the topical steroid. It is recommended, therefore, that clobetasol propionate should be applied twice daily for the control of severe cases of psoriasis of the scalp.     

Calcipotriol/betamethasone dipropionate: a review of its use in the treatment of psoriasis vulgaris of the trunk, limbs and scalp

Calcipotriol/betamethasone dipropionate (calcipotriol 50?μg/g and betamethasone 0.5?mg/g) is a fixed-dose combination of a vitamin D(3) analogue and a corticosteroid indicated for the once-daily, topical treatment of psoriasis vulgaris of the trunk, limbs and scalp in adults. Both the ointment (Daivobet?; Dovobet?) and gel (Xamiol?; Daivobet? Gel; Dovobet? Gel) formulations of calcipotriol/betamethasone dipropionate can be used to treat psoriasis vulgaris of the trunk and/or limbs, although the gel formulation was specifically developed for the treatment of scalp psoriasis. This article reviews the efficacy and tolerability of calcipotriol/betamethasone dipropionate in patients with psoriasis vulgaris, as well as summarizing its pharmacological properties. Calcipotriol/betamethasone dipropionate has low systemic absorption and displays local anti-inflammatory and immunoregulatory properties. It reduces the hyperproliferation of keratinocytes and helps normalize keratinocyte differentiation. In large, well designed clinical trials, calcipotriol/betamethasone dipropionate, either as the ointment or the gel formulation, applied once daily for 4-8 weeks, was more effective than placebo, calcipotriol and tacalcitol, as well as betamethasone dipropionate in most instances, for the topical, symptomatic treatment of psoriasis vulgaris of the trunk/limbs. Likewise, calcipotriol/betamethasone dipropionate gel applied once daily for 8 weeks was more effective than placebo or either component alone in the topical, symptomatic treatment of psoriasis vulgaris of the scalp. Long-term, once-daily, when required therapy with calcipotriol/betamethasone dipropionate for 52 weeks was more effective than calcipotriol alone for the treatment of scalp psoriasis, and was at least as effective as switching to calcipotriol for 48 weeks after 4 weeks of calcipotriol/betamethasone dipropionate or alternating between calcipotriol/betamethasone dipropionate and calcipotriol every 4 weeks for 52 weeks in the treatment of psoriasis vulgaris of the trunk/limbs. Calcipotriol/betamethasone dipropionate also improved health-related quality of life. Calcipotriol/betamethasone dipropionate was generally well tolerated, with most adverse drug reactions being lesional or perilesional effects of mild or moderate severity. Calcipotriol/betamethasone dipropionate was often associated with fewer lesional/perilesional adverse reactions than calcipotriol or tacalcitol and did not appear to be associated with a higher incidence of corticosteroid-related adverse events during long-term therapy. Pharmacoeconomic analyses predicted calcipotriol/betamethasone dipropionate to be more cost effective than other topical therapies. Thus, calcipotriol/betamethasone dipropionate is an important, effective, once-daily, topical therapy for the symptomatic treatment of psoriasis vulgaris of the trunk, limbs and scalp.     

Application of dermal microdialysis for the determination of bioavailability of clobetasol propionate applied to the skin of human subjects

Dermal microdialysis was used to assess the bioavailability of a topical corticosteroid, clobetasol propionate, following application onto the skin of human subjects. The penetration of clobetasol propionate from a 4% m/v ethanolic solution applied onto 4 sites on one forearm of healthy human volunteers was studied. A lipid emulsion, Intralipid?, was used as the perfusate and linear microdialysis probes with a 2-kDa cutoff were inserted intradermally at the designated sites. The results indicated that Intralipid could be used as a suitable perfusate for in vivo microdialysis of this lipophilic drug of interest. Furthermore, the study clearly demonstrated the application of dermal microdialysis as a valuable tool to assess the bioavailability/bioequivalence of clobetasol propionate penetration into the skin following topical application.     

Comparison of the efficacy and safety of 0.1% tacrolimus ointment with topical corticosteroids in adult patients with atopic dermatitis: review of randomised, double-blind clinical studies conducted in Japan

Tacrolimus (FK506) ointment is widely used in the treatment of patients with atopic dermatitis. The drug exerts its action by down-regulating antigen-specific T-cell activities and associated proinflammatory cytokine production. A number of clinical studies have evaluated the efficacy and safety of 0.1% tacrolimus ointment compared with vehicle or topical corticosteroids in adult patients with atopic dermatitis. These studies have suggested that topical tacrolimus has a rapid onset of action and exerts sustained therapeutic effects, with an efficacy similar to that of moderate to potent topical corticosteroids, but without causing skin atrophy. Two phase III randomised, controlled clinical trials have been conducted in Japanese adult patients with atopic dermatitis to compare the efficacy and safety of topical 0.1% tacrolimus with topical corticosteroid ointments. In the first study, patients with moderate or severe atopic dermatitis on the trunk and extremities were randomised to 3 weeks of treatment with topical 0.1% tacrolimus or the mid-potency topical corticosteroid 0.12% betamethasone valerate. Over 90% of the patients in each study group experienced at least a moderate improvement at the end of the study. In the second study, patients with moderate or severe atopic dermatitis on the head or neck were randomised to 1 week of treatment with 0.1% tacrolimus or the mild-potency corticosteroid 0.1% alclometasone dipropionate. Significantly greater improvements in individual symptom scores were observed with topical tacrolimus compared with alclometasone dipropionate, with overall global improvement at 1 week being statistically superior with tacrolimus. Furthermore, in a long-term open-label study involving 568 patients, at least a moderate global improvement in symptoms was observed in 85% of patients at 6 weeks, increasing to 91% at both 26 weeks and 52 weeks; this rate was maintained throughout the 2-year duration of the study. 0.1% tacrolimus ointment was considered to be safe in the majority of patients. The most prevalent adverse reactions were local application site irritations, which generally resolved with continued therapy. In summary, these findings suggest that 0.1% tacrolimus ointment is an effective and safe nonsteroidal alternative therapy for adult patients with atopic dermatitis.