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Topical corticosteroids (TCSs) are a major part of the foundation of treatment for a wide variety of eczematous and inflammatory skin disorders in both adults and children. Mid-potency TCSs represent an important category as they are often used to treat eczematous dermatoses, such as atopic dermatitis. The TCS product must effectively release the active ingredient and promote cutaneous penetration so that therapeutic activity can occur. As many topical products eventually become available as generic formulations, it is important to recognize that although the active ingredient and its concentration are the same, the vehicle excipients may differ significantly, occasionally leading to potential differences in irritancy, in allergenicity, in effects on epidermal permeability barrier function, and, possibly, in efficacy. Clocortolone pivalate 0.1% cream is a mid-potency TCS formulated in an emollient formulation that has been shown to be effective and well-tolerated in the management of several corticosteroid-responsive dermatoses. This article outlines the pharmacologic and clinical data achieved with the original brand formulation of clocortolone pivalate 0.1% cream, and discusses the establishment of an authorized generic formulation that is identical in formulation to the original brand.

As the accumulated clinical evidence and experience to be presented in the next several pages demonstrate, the unique engineering of the clocortolone pivalate molecule balances potency with documented efficacy and a favorable safety profile. Clocortolone pivalate 0.1% cream is a well-formulated and versatile therapeutic option to consider for many of our patients with steroid-responsive dermatoses.

Midpotency topical corticosteroids (TCSs) are frequently used for the treatment of common eczematous and inflammatory skin disorders in both adults and children. There are several commercially available products in this category, and many vehicles and formulations for the clinician to choose from. Clocortolone pivalate 0.1% cream is a midpotency TCS formulated in an emollient formulation that has been shown to be effective and well tolerated when used appropriately in the management of several corticosteroid-responsive dermatoses. This article discusses the physiochemical properties of the compound; the characteristics of its emollient cream formulation; the functions of individual excipients; and the efficacy, tolerability, and safety data supporting its use in adults and children, including for facial involvement.

Objective: Study results evaluating the efficacy and safety of clocortolone pivalate 0.1% cream in the treatment of adults, young children, and infants with inflammatory facial dermatoses are reported in this article. Clocortolone pivalate 0.1% cream, indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, is a mid-potency topical corticosteroid (Class 4) that has been studied and used extensively to treat a variety of corticosteroid-responsive inflammatory dermatoses, many of which often involve facial skin in both adults and children., Methods: Clocortolone pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin., Results: Treatment with clocortolone pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis)., Conclusion: Clocortolone pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.

Background: Graves' disease (GD) is an autoimmune disease that typically affects the thyroid gland. Thirty to sixty percent of patients also suffer from orbital inflammation. Retrobulbar radiotherapy for Graves' orbitopathy (GO) has been used for decades, though there is no direct evidence for the influence of dose and fractionation schedules on various signs and symptoms. Indeed, optimal fractionation schedules and recommended total irradiation doses are still a matter of discussion. Our aim was to investigate treatment efficacy of retrobulbar irradiation for GO at different total absorbed doses and fractionation schedules., Methods: A retrospective evaluation of 129 patients who were examined before, as well as 6-8 months after irradiation with different treatment schedules at eight radiotherapeutic departments. Total absorbed doses were 12, 16, or 20 Gy. All patients were additionally treated with systemic application of corticosteroids. Treatment efficacy was evaluated through assessment of proptosis, horizontal and vertical ocular motility and of clinical activity (CAS). Overall group and individual responses were evaluated. Treatment response was defined as inactivation of GO, reduction of proptosis by at least 2 mm, improvement of motility by > or = 8 degrees or unchanged normal parameters., Results: Prior to irradiation, neither age, disease duration, gender distribution, smoking behavior or serologic parameters, nor clinical activity or severity stages varied significantly between groups. Neither did outcome measures, except proptosis, differ significantly. Retrobulbar irradiation led to inactivity of GO in approximately 80% of patients, with no significant group difference. After irradiation with 16 and 20 Gy, vertical motility improved in a significantly higher percentage of patients than after irradiation with 12 Gy. Median improvement of vertical motility in responding patients was excellent in all groups (15 degrees at 12 Gy, 10 degrees at 16 Gy, 10 degrees at 20 Gy). Horizontal motility did not change significantly., Conclusion: If the aim of retrobulbar irradiation is primarily to reduce soft-tissue signs, lower doses are sufficient. If a patient also suffers from dysmotility, doses exceeding 12 Gy may be more effective.

Objective: The following is a case presentation of congenital syphilitic keratitis in a boy 6 years of age who was successfully treated with an immunosuppressive drug combination therapy., Methods: Congenital syphilitic keratitis was diagnosed by clinical findings and laboratory tests. The child was unresponsive to traditional treatment; thus, systemic immunosuppressive therapy, which consisted of oral cyclosporine 4 mg/kg/d, 6 days per week, and oral low-dose steroids (fluocortolone 0.8 mg/kg a week, given every other day), was initiated., Results: Corneal disease showed great improvement with this therapy, with progressive healing of lesions in the first month of treatment and no signs of toxic renal, hepatic, or growth abnormalities. Recurrences of uveitis have not occurred, and corneal interstitial keratitis episodes have been limited to 3 in an 8-year period. After 6 months with no recurrences, a tapering off of the systemic therapy was initiated, and the child is still asymptomatic and without flare-ups., Conclusions: Congenital syphilitic keratitis is usually treated with topical steroids and cycloplegic drugs, which not only can be ineffective but can also lead to complications such as cataract and glaucoma. In the present case report, a pediatric patient affected by syphilitic interstitial keratitis was treated successfully with an immunosuppressive drug combination therapy.

Background: Erythrodermic cutaneous T-cell lymphomas (CTCL) including Sézary syndrome have been successfully treated with daily administration of chlorambucil and prednisone (Winkelmann regimen)., Objectives: Our purpose was to determine the efficacy and safety of a low-dose pulse chemotherapy with chlorambucil and fluocortolone in this stage of the disease. Fluocortolone has the same potency as prednisone but lacks a mineralocorticoid effect., Patients/methods: Thirteen patients with erythrodermic CTCL (stages III-IVb) were treated with chlorambucil and fluocortolone therapy (chlorambucil 10-12 mg day-1 for 3 days and fluocortolone, first day 75 mg, second day 50 mg and third day 25 mg) as primary therapy in an uncontrolled pilot study. Treatment was started with pulses every 2 weeks; subsequently, the intervals were prolonged according to the clinical status. Clinical outcome, side-effects and long-term survival were assessed., Results: Seven patients achieved a complete remission and six had a partial response (improved significantly). The mean duration of remissions was 16.5 (median 12) months. The mean number of cycles necessary during the first year was one cycle every 5 weeks. No treatment-related severe side-effects occurred. The long-term follow-up (mean 31.5, median 27 months) showed that six patients remained in complete remission and three showed a stable partial remission. Four patients died, two of them from their lymphoma., Conclusions: We conclude that pulse chemotherapy with chlorambucil and fluocortolone is effective and safe in the treatment of erythrodermic CTCL and should be considered as an alternative to the classical Winkelmann treatment scheme.

Objective: The therapeutic efficacy and tolerability of the combination of cyclosporin A, methotrexate and fluocortolone was evaluated after 96 months of treatment in 140 patients with rheumatoid arthritis., Methods: The initial dose of CyA was 5 mg/kg per day and was subsequently modified on the basis of the individual clinical response. Fluocortolone was initially administered at a dose that was sufficient to control disease activity (80-130 mg/week) and then was gradually tapered down to a maintenance dose of 15-20 mg/week. MTX was given intravenously at a dose of 15 mg once weekly for 4 consecutive weeks and then, after a 2-week interval, every 2 weeks or every month depending on the evolution of the disease., Results: At the end of the study a statistically significant improvement was observed in both clinical (VAS, grip-strength, duration of morning stiffness, number of swollen joints, number of painful joints, Ritchie's index and Lee's functional index) and laboratory parameters: ESR (p = 0.000); alpha 2 globulins (p = 0.000); hemoglobin (p = 0.000); CRP (p < 0.001); and rheumatoid factor (p = 0.000). Radiological evaluation revealed little progression in anatomic lesions (Larsen score p = 0.699; number of erosions p = 0.344), thus suggesting that our protocol may be capable of showing down both bone resorption and cartilage loss. Renal toxicity, defined as an increase in plasma creatinine concentrations of more than 50% of the baseline value, was observed in 12 patients (8.5%), but the drug was discontinued in only one, who simultaneously presented high blood pressure., Conclusion: The positive results so far achieved in our study must be interpreted as being due to the combined action of the individual drugs, which made it possible for them to be used at relatively low dosages that minimised the onset of their side effects while maintaining the efficacy of their suppressive action.

Background: The aim of this prospective study was to evaluate the efficacy of a combined (local and systemic) steroid therapy on the extent of chronic polypoid rhinosinusitis and patient symptoms., Methods and Patients: Subjects of this study were 20 patients with severe chronic polypoid rhinosinusitis with total or subtotal narrowing of the all sinuses. A nasal budesonide spray (2 x 0.1 mg/day) and an oral fluocortolone medication with a daily reduction during a 12-day period (total dose: 560 mg = group 1) and a 20-day period (total dose: 715 mg = group 2), respectively, were administered. Before and after the steroid treatment we evaluated the extent of the sinusitis with MRI and patient symptoms with symptom-related questionnaires., Results: A significant reduction (> 30%) of the chronic polypoid rhinosinusitis was observed in 50% of MRI findings. The steroid effect on polypoid masses was heterogeneous in different anatomic areas (maxillary sinus 40%, anterior ethmoid 19%, posterior ethmoid 33%, sphenoidal sinus 61%, frontal sinus 46%). Most sinusitis-related symptoms were distinctly diminished in most patients (80%). No major side effects were observed., Conclusions: A combined short-term steroid therapy is highly effective in chronic polypoid rhinosinusitis, reducing the mucosal inflammation mainly in the large sinuses and reducing the incidence of symptoms significantly. However, this therapy was insufficient in the anterior ethmoid and cannot replace the current surgical treatment concept of the osteomeatal complex in CPR. The indication for such a short-term steroid therapy is the preoperative treatment. It facilitates functional endoscopic sinus surgery by reducing the extent of surgical procedures, the time, and thereby the risks of sinus surgery.

Eleven patients with chronic sarcoidosis resistant to high-dose corticosteroids and other immunosuppressive treatments were treated with cyclosporine A at the initial daily dose of 5 mg per kg body weight (ideal weight in the case of overweight subjects) combined with flucortolone and methotrexate. A complete and lasting remission of the disease was obtained in all patients with total disappearance of pulmonary and extrapulmonary manifestations. In addition, the disease activity indexes normalized and remained normal for the rest of the follow-up period (24.82 +/- 8.22 months, range 12-33). No renal or hepatic toxicity was observed in any patient. Two of them presented hypertrichosis and one nausea.

We compared the effects of increasing doses of beclomethasone dipropionate (BDP) and fluocortin butylester (FCB) on several indices of pituitary-adrenal function in healthy adult subjects. Significant depression of urinary free cortisol excretion and the response to metyrapone was seen only at the highest dose (1600 mg/day) of BDP. This depression was not reflected by frequent measurement of the serum cortisol concentration. FCB used well in excess of its presumed therapeutic dose range showed no evidence of any effect on pituitary-adrenal function. These results confirm that at high doses BDP causes pituitary adrenal suppression. Differences from studies showing reduced adrenal function in children on BDP doses of 400 to 800 mg/day probably reflect differences in the dose per kilogram of body weight. Since the use of FCB was not accompanied by any adverse side effects or evidence of reduced pituitary-adrenal function, it may be a variable alternative for asthmatics who require high doses of inhaled glucocorticoid.

Corticoids given therapeutically may interrupt the loop on feedback mechanism by which plasma cortisol levels are controlled. This was demonstrated when corticoids were applied to the skin in the treatment of dermatoses and when taken by mouth the patients with polyarthritis. In rats, Endomethasone root fillings has similar effect. Corticoids applied to the gingiva or instilled into periodontal pockets did not lower group mean plasma cortisol levels but individual patients did show suppression of cortisol secretion. It is concluded that all corticoids, no matter how applied, will have this effect, although present analytical methods may be too insensitive to detect the smaller changes.