Superpotent Topical Corticosteroids Research Articles

Halobetasol propionate 0.05 % cream: a guide to its use in the treatment of plaque psoriasis

Topical halobetasol propionate 0.05 % (Halobex®, Halovate®, Ultravate® and others), a super-potent topical corticosteroid, is effective and well-tolerated in the short-term treatment of plaque psoriasis. Topical combinations of halobetasol propionate 0.05 % and other agents have also shown promising results.

Sequential Stevens–Johnson syndrome and photo‐recall phenomenon

Funding sources: none. Conflicts of interest: none declared. Madam, A 68‐year‐old woman with diffuse large B‐cell lymphoma of the brain was started on a chemotherapeutic regimen consisting of high‐dose intravenous methotrexate (MTX) at a dose of 2·5 g m−2 and procarbazine at a dose of 200 mg daily. Other medications started concurrently included dexamethasone, allopurinol and omeprazole. Fourteen days later, she developed an extensive rash with mouth ulcers and fever. Clinical examination showed atypical targets that were mainly truncal in distribution associated with buccal mucositis, anogenital erosions and fever. The skin biopsy showed full‐thickness apoptosis of keratinocytes, focal basal liquefactive degeneration and lymphocyte exocytosis with a chronic inflammatory infiltrate consisting of lymphocytes, histiocytes and eosinophils. A diagnosis of Stevens–Johnson syndrome (SJS) was made. An infection screen was negative. Allopurinol was deemed to be the culprit drug and was stopped. Superpotent topical corticosteroid ointment (clobetasol propionate) was prescribed with resolution of the rash 1 week later. She was readmitted electively 2 weeks later for further chemotherapy. Unfortunately, allopurinol was inadvertently reintroduced and there was a recrudescence of the rash with scattered atypical targets on the trunk. Allopurinol was immediately stopped and the target lesions settled rapidly. Two days later, she was commenced on her second cycle of chemotherapy consisting of MTX and procarbazine. Over the next 5 days, she developed a new dermatosis in a sun‐exposed distribution. There was a well‐defined erythema with oedema over the extensor aspects of both upper limbs and erythematous, scaly plaques over the V of the neck (Fig. 1). The autoimmune screen was unremarkable (negative antinuclear antibodies and extracted nuclear antigens, normal complement levels). A repeat biopsy of the lesional skin showed scattered apoptotic cells and focal squamatization of the basal layer overlying extensive solar elastosis and a scanty perivascular infiltrate of lymphocytes (Fig. 2). The clinical presentation and histology was suggestive of a photo‐recall phenomenon which was triggered by her chemotherapy, most likely MTX. She was started on prednisolone 0·5 mg kg−1 with improvement and was maintained on systemic corticosteroids during her subsequent cycle of chemotherapy with no further recurrences.

Microparticulate Based Topical Delivery System of Clobetasol Propionate

Psoriasis is a chronic, autoimmune skin disease affecting approximately 2% of the world's population. Clobetasol propionate which is a superpotent topical corticosteroid is widely used for topical treatment of psoriasis. Conventional dosage forms like creams and ointments are commonly prefered for the therapy. The purpose of this study was to develop a new topical delivery system in order to provide the prolonged release of clobetasol propionate and to reduce systemic absorption and side effects of the drug. Clobetasol propionate loaded-poly(D,L-lactic-co-glycolic acid) (PLGA) microspheres were prepared by oil-in-water emulsion-solvent evaporation technique. Particle size analysis, morphological characterization, DSC and XRD analyses and in vitro drug release studies were performed on the microparticle formulations. Emulgel formulations were prepared as an alternative for topical delivery of clobetasol propionate. In vitro drug release studies were carried out from the emulgel formulations containing pure drug and drug-loaded microspheres. In addition, the same studies were performed to determine the drug release from the commercial cream product of clobetasol propionate. The release of clobetasol propionate from the emulgel formulations was significantly higher than the commercial product. In addition, the encapsulation of clobetasol propionate in the PLGA microspheres significantly delayed the drug release from the emulgel formulation. As a result, the decrease in the side effects of clobetasol propionate by the formulation containing PLGA microspheres is expected.

Topical corticosteroid abuse on the face: A prospective, multicenter study of dermatology outpatients

Abuse of topical corticosteroids (TC), especially over the face, is prevalent worldwide, including in India. Data about the magnitude of this problem in our country is lacking. The aims of this study were to ascertain the demographics, magnitude and clinical features of TC misuse on the face in the dermatology outpatient department (OPD) attendees in order to raise awareness about this problem and to analyze its causes. This was a prospective multicenter questionnaire-based clinical study conducted at 12 dermatology centers nationwide. Patients with relevant facial dermatoses reporting to the investigator were asked about their current use of over-the-counter topical formulations and a structured questionnaire applied in case the same was confirmed to be TC. A total of 2926 patients with facial dermatoses were screened, of which 433 (14.8%) were using TC. TC was used as a fairness/general purpose cream or aftershave in 126 (29%) and in 104 (24%) for acne. Steroid combinations were used by 258 (59.6%). Potent and super-potent TC were significantly (P = 0.05) more frequently used by the rural/suburban population. The younger age groups used more potent formulations. A non-physician recommendation for TC use was obtainable in 257 (59.3%) patients. Of these, 232 (90.3%) were for potent/super-potent steroids. Among 176 physician prescriptions, 78 (44.3%) were from non-dermatologists. All non-physician prescriptions and 146 (83%) physician prescriptions for TC were inappropriately refilled. Adverse effects were seen in 392 (90.5%) TC users. Acne/exacerbation of acne was the most common adverse effect. TC misuse in patients with facial dermatoses is quite common, and most of this use is unwarranted. Use as a fairness cream is the most common indication in this cohort. This was an OPD-based study and, therefore, it may or may not accurately reflect the community data.

Vulval lichen sclerosus and lichen planus

Lichen sclerosus (LS) and lichen planus (LP) are both immunologically mediated diseases with a preference for the genitalia. The basic principles of management of vulval LS and vulvovaginal LP are the same and involve explanation of the disease, emphasizing the chronic nature of the condition and outlining treatment options. The main difference between the two conditions is that LP has a propensity to involve the mucous membranes including the mouth and vagina which are rarely affected in LS. First-line treatment for LS is a super-potent topical corticosteroid ointment which has a high response rate. Erosive vulvovaginal LP is more challenging to treat. Second-line therapies include topical calcineurin inhibitors and systemic agents. There is limited evidence for systemic treatments for both conditions. The risk of vulval squamous cell carcinoma (SCC) is increased in both LP and LS, and it is not known how treatment affects this risk. We recommend teaching self-examination and longitudinal evaluation.

Long‐term management of vulval lichen sclerosus in adult women

Adult vulval lichen sclerosus (VLS) is usually a lifelong disease with an estimated remission rate after treatment of only 16% [Arch Dermatol 2004; 140 (6): 709]. Although superpotent topical corticosteroid (TCS) is the validated gold standard treatment to induce remission, little data are available on how remission should be maintained. We present a retrospective chart review of 129 adult patients with VLS who have been under surveillance by the authors for a minimum duration of three years. Remission was maintained in most patients with low-to-moderate potency TCS. All subjects' symptoms, signs, treatment regimes and response to treatment including compliance, symptom remission, disease progression with scarring, squamous cell carcinoma and side effects were recorded. Data were compared for the compliant and non-compliant groups. Fischer's exact test was used to identify significant differences. The mean age at presentation was 53.6 years and mean duration of follow-up was 6.2 years. Compliance was excellent: 84 (65%) of patients' self-reporting as being fully compliant. Symptom remission was achieved in 98% of compliant and 75% of non-compliant patients (P = 0.001) Progression of disease with scarring was not encountered in any of the compliant patients, but was seen in 35% of non-compliant patients (P = 0.0001). One patient had squamous cell carcinoma on first presentation. Carcinoma subsequently occurred in none of the compliant patients, and in five partly compliant patients (P = 0.004). Mild, reversible corticosteroid side effects were encountered in 7% of patients. Long-term treatment of adult VLS with individualised regimes using moderate potency TCS is safe and effective. Patients require long-term follow-up.

A Comparison of Two Regimens of Topical Corticosteroids in the Treatment of Patients with Bullous Pemphigoid: A Multicenter Randomized Study

Superpotent topical corticosteroids (CS) have been demonstrated to improve bullous pemphigoid (BP) patients' survival. We assessed whether a mild regimen using lower doses of topical CS and a shorter duration could improve the outcome of BP patients even more. Three-hundred and twelve BP patients were included in a multicenter randomized controlled trial and stratified depending on the extent of BP as moderate (n=134) or extensive (n=178). Patients were randomly assigned to the standard regimen (clobetasol propionate cream, 40 g per day initially, with CS tapering over 12 months) or the mild regimen (10-30 g per day), with CS tapering over 4 months. A noninferior rate of BP control was obtained with the mild regimen 156/159 (98%) as compared with the standard regimen 150/150 (100%; P=0.005). Event-free survival, that is, the combined outcome of deaths and life-threatening adverse events did not differ between the two treatment groups (P=0.77). However, upon adjusting through the Cox model for age and Karnofsky score, a strong beneficial effect of the mild regimen was observed in patients with moderate BP, with an almost twofold decrease in the risk of death or life-threatening adverse events relative to the standard regimen (hazard ratio=0.54; 95% confidence interval, 0.30-0.97; P=0.039). This mild regimen allows a 70% reduction of the cumulative doses of CS and improves BP patients' outcome.

Topical Corticosteroids and Topical Calcineurin Inhibitors in the Treatment of Atopic Dermatitis: Focus on Percutaneous Absorption

The 2 primary classes of drugs used to treat atopic dermatitis (AD) are topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs). For maximum efficacy, topical agents must efficiently penetrate the skin but, for optimal safety, should not be absorbed into the bloodstream. TCSs, a mainstay in AD treatment for more than 50 years, can potentially be absorbed into the systemic circulation, particularly when used on young children, for prolonged periods, or on areas of thin and sensitive skin, such as the eyelids, face, and flexures. There is a risk of cutaneous and systemic adverse events, including suppression of the hypothalamic-pituitary-adrenal axis and related sequelae, especially when potent or superpotent TCSs are used for extended periods. Ideally, TCSs should be used for short periods (2-4 weeks), but clinical reality often necessitates longer use. TCIs also effectively and safely treat AD, with the most commonly observed local adverse events being skin irritation and burning. These agents have demonstrated good penetration of the skin with minimal systemic absorption, as evidenced by low blood concentrations, and can be used safely on thin and sensitive skin. The use of mid-potency TCSs to treat acute flares involving skin of normal thickness, followed by the introduction of TCIs for maintenance therapy, constitutes an appropriate application of both drug classes. Pharmacists with a clear understanding of how both types of agents affect the systemic circulation have the opportunity to inform patients and caregivers about benefits and limitations of different therapeutic agents, address patient concerns about adverse events, and help patients understand how to use medical therapies appropriately.

Vulval and perianal inflammatory linear verrucous epidermal naevus

Inflammatory linear verrucous epidermal naevus (ILVEN) is a rare form of epidermal naevus. It occurs as a linear dermatitic or psoriasiform plaque, with onset usually in the first 5 years of life. Lesions are characteristically intensely itchy. We present a case of ILVEN occurring on the vulva and perianal region of a 6-year-old girl. The lesion was initially thought to be an area of lichenified dermatitis; however, treatment with even super-potent topical corticosteroids did not significantly improve the inflammation. A biopsy was performed and histopathological examination showed characteristic features. ILVEN is frequently refractory to topical treatment and surgical excision of lesions may be an option for relief of symptoms. ILVEN occasionally presents in the inguinogenital region and in this area may, like many vulval naevi, be misdiagnosed as vulvitis, psoriasis, genital warts or sexual abuse.

Profil évolutif des patients atteints de pemphigoïde bulleuse au cours de la première année de traitement

Since high doses of superpotent topical corticosteroids (CS) have been shown to improve the survival of bullous pemphigoid (BP) patients and to be more effective than oral CS, few studies have described the long-term course of the disease of these patients. We report the course of BP in the Limoges region of France based on patients diagnosed successively between 2002 and 2004. This was a retrospective, single-centre study of 54 BP patients diagnosed with BP, conducted by the Department of Dermatology of the Limoges University Hospital over a 3-year period. We investigated epidemiological data, initial symptoms, type of treatment received and outcome at six and 12 months. The two primary end-points were disease control at month 12 and the combined outcome of deaths and relapse over the one-year follow-up period. We calculated the number of deaths, patients lost to follow-up, relapses, and remission at months 6 and 12. Between January 2002 and December 2004, 54 new BP patients were diagnosed in the Limoges Department of Dermatology: 18 male and 36 female, median age 84 years. Forty patients were treated with superpotent topical CS, 14 required adjuvant immunosuppressant treatment (oral CS, methotrexate, dapsone, mycophenolate mofetil, leflunomide). Over the first 6 months, 28 patients could not be further investigated due to death (n = 20) or loss to follow-up (n = 8). In the 26 patients evaluable for treatment efficacy at month 6, control of the disease was achieved in 17 patients, and nine relapses were seen. The one-year Kaplan-Meier survival rate was 56%. Among the 23 patients evaluable at month 12, control of disease was achieved in 13 patients (complete remission without treatment, n = 2; remission with immunosuppressant treatment, n = 8). Therapeutic failure was concluded for 16 patients, eight of whom presented two relapses during the first year of follow-up. Despite recent therapeutic recommendations for BP, the prognosis of this disease remains severe. The risk of relapse and mortality rates observed in this study should prompt the development of new therapeutic strategies to supplant superpotent topical CS and reduce the morbidity and mortality associated with the disease.

Topical Halobetasol Propionate in the Treatment of Plaque Psoriasis

Halobetasol propionate (HP) 0.5% ointment and cream are class I topical corticosteroids. We review the efficacy and tolerability of HP for treatment of plaque psoriasis in the English language literature. The efficacy of HP ointment and cream is consistently superior to other super-potent topical corticosteroids. Local adverse events associated with topical HP are similar to those experienced with other super-potent corticosteroids. Combination therapy with calcipotriene (calcipotriol) and tazarotene appears to be superior to monotherapy with topical HP.

Use of superpotent topical corticosteroids for psoriasis patients in the U.S.

Most patients with psoriasis have relatively localized disease that can be managed with topical therapy. Nevertheless, the characteristics of topical therapy are such that treatment is one of the most bothersome aspects of psoriasis. The primary topical therapy used in the U.S. for psoriasis is topical corticosteroid, particularly ultrapotent topical corticosteroids. New topical therapies and localized phototherapy have been developed to offer patients alternatives to topical corticosteroids. The purpose of this study was to determine to what extent new treatments have changed the use of superpotent topical corticosteroids in psoriasis patients. We analyzed data from the 1990-2000 National Ambulatory Medical Care Survey, a representative survey of visits to U.S. physician offices. Visits for psoriasis were identified by the ICD-9CM diagnosis 696.1, and medications mentioned at these visits were compiled and analyzed. Ultrapotent topical corticosteroids were prescribed at 4 million visits to physicians for psoriasis over the 1990-2000 interval. There was no significant change in the frequency of ultrapotent topical corticosteroids over the interval. While the development of new anti-psoriasis agents has not led to any significant decrease in the use of ultrapotent topical corticosteroids, they may have played a role in limiting growth in use of these agents.

Retrospective analysis of the treatment of psoriasis of the palms and soles

In this retrospective analysis, the effect of currently used treatments in 26 patients with psoriasis of the palms and soles were analyzed. In general, patients are treated initially with topical medications including superpotent topical corticosteroids in combination with calcipotriene ointment or tazarotene gel or both. If satisfactory improvement is not achieved in 4–8 weeks, systemic retinoids are added, formerly etretinate and currently acitretin, except in women of childbearing potential. If the latter regimen is not effective within two months, soak PUVA is added to the regimen of oral retinoids and topical medications. If improvement is inadequate, or if the treatment regimen is not tolerated, methotrexate or cyclosporine have been added in the past. The availability of the excimer laser has recently modified our approach so that this therapy is used in combination with acitretin before soak PUVA. With the availability of biologic agents, methotrexate is avoided because of its hepatotoxicity and bone marrow toxicity and cyclosporine is avoided because of its nephrotoxicity. If oral acitretin plus topical therapy is not adequate to control the disease and the excimer laser is not an option because of its limited availability, alefacept, etanercept and infliximab are added when possible. Other biologic agents are likely to be added to this list in the future.

Calcipotriene ointment and halobetasol ointment in the long-term treatment of psoriasis: Effects on the duration of improvement

Background: Weekend therapy with superpotent topical corticosteroids has been used for the long-term treatment of psoriasis. Recently, calcipotriene ointment has been added to this regimen for use on weekdays, but there are no long-term studies of that combination. Objective: The purpose of this study was to determine whether the addition of weekday calcipotriene to a pulse therapy regimen of weekend superpotent corticosteroids results in a longer duration of remission of plaque psoriasis. Subjects: This was a double-blind, placebo-controlled, parallel-group study. Forty-four patients with mild to moderate psoriasis were treated with calcipotriene ointment in the morning and halobetasol ointment in the evening for 2 weeks. Thereafter, 40 patients who were at least moderately (50% or greater) improved were randomized to 2 treatment groups. After 2 weeks of treatment with calcipotriene ointment in the morning and halobetasol ointment in the evening, 20 patients were randomized to receive halobetasol ointment twice daily on weekends and calcipotriene ointment twice daily on weekdays, and 20 patients were randomized to receive halobetasol ointment twice daily on weekends and placebo ointment twice daily on weekdays. Results: Seventy-six percent of patients applying halobetasol ointments on weekends and calcipotriene ointment on weekdays were able to maintain remission for 6 months compared with 40% of patients applying halobetasol ointment on weekends only with the vehicle on weekdays. Conclusion: The addition of calcipotriene ointment applied on weekdays to a weekend pulse therapy regimen of superpotent corticosteroids can increase the duration of remission of psoriasis. (J Am Acad Dermatol 1998;39:447-50.)

Lymphomatoid papulosis: successful weekly pulse superpotent topical corticosteroid therapy in three pediatric patients.

Lymphomatoid papulosis is a T-cell proliferation that occurs primarily in adults but has been well described in children. Lesions may regress spontaneously but often leave residual scarring and, as a result, intervention frequently is considered. Therapeutic modalities commonly employed for adults with lymphomatoid papulosis may be poorly tolerated by pediatric patients. We present a series of three children with lymphomatoid papulosis treated with superpotent topical corticosteroids (halobetasol or clobetasol propionate). When applied twice daily for 2 to 3 weeks followed by weekly pulsed application, this treatment resulted in complete resolution of nearly all cutaneous lesions. Three ulcerated lesions, occurring in two patients, required adjuvant therapy with intralesional triamcinolone. To date one patient remains free of cutaneous disease and two children experience occasional new lesions that respond to renewed treatment with topical clobetasol propionate. None of the children have evidence of systemic disease. We conclude that pulsed application of a superpotent topical corticosteroid is efficacious and safe in the management of cutaneous lesions of lymphomatoid papulosis and avoids the risks often associated with more aggressive interventions. Since these agents do not alter the risk of subsequent malignancy, careful ongoing surveillance of children with lymphomatoid papulosis is imperative.

The Potency, Efficacy, and Usage of Superpotent Topical Corticosteroids

The Potency, Efficacy, and Usage of Superpotent Topical Corticosteroids