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Medical research on clobetasol
Topical preparations for the treatment of psoriasis: Results of a retrospective study over 15 years.
J Dermatolog Treat. 2008; 19(3): 134-40
Zampetti A, Barone A, Antuzzi D, Amerio P, Tulli A, Feliciani C, Amerio P
Background: Psoriasis requires lifelong treatments that depend on the extent, clinical forms and associated conditions. Objective: To retrospectively analyze which topical treatments were used, their efficacy, and potential advantages and disadvantages. Methods: A total of 666 patients admitted for the first time over 15 years who were topically treated were retrospectively reviewed and subdivided using clinical forms and PASI into four groups and four subgroups for the applied treatments. For each treatment the mean PASI was calculated daily: on the first, third and sixth day. An X sample statistical analysis and Mann--Whitney U-test were performed. The hospitalization time and correlation with the response to treatment were analyzed. Results: A statistically significant response was recorded for every regimen. The best combination was clobetasol propionate plus eosin on alternate days with eosin plus cade oil. The highest score was recorded for the 'en plaques' psoriasis. The average length of treatment was of 7.5 days in the best combination. No statistically significant difference among the groups was recorded with respect to the length of hospitalization and PASI. Conclusion: The statistically significant response for all the topical treatments analyzed and recorded in this study does not exclude a potential benefit due to hospitalization per se.
J Am Acad Dermatol. 2008 Jun 6;
Kimball AB, Gold MH, Zib B, Davis MW,
BACKGROUND: Clobetasol propionate 0.05% emulsion foam was recently developed for use on multiple body sites. OBJECTIVE: We sought to evaluate safety and efficacy of clobetasol emulsion foam 0.05% to treat steroid-responsive dermatoses in multiple age groups. METHODS: A phase II open-label study evaluated the effect of clobetasol foam on the hypothalamic-pituitary-adrenal axis in 52 participants aged 6 years or older with mild-to-severe atopic dermatitis (AD). Cosyntropin stimulation test was used to determine the effect of clobetasol foam on hypothalamic-pituitary-adrenal axis, with a normal response considered to be a postinjection serum cortisol level greater than 18 mug/dL. Another phase II open-label pharmacokinetic safety study was conducted in 32 participants aged 12 years or older with mild-to-moderate plaque-type psoriasis. Pharmacokinetic parameters evaluated included maximal plasma concentration of clobetasol propionate, time to achieve maximum concentration, and area under the curve. Two phase III, randomized controlled studies assessed treatment success in participants aged 12 years or older with moderate-to-severe AD (N = 377) or mild-to-moderate plaque-type psoriasis (N = 497). In all studies, participants received study drug for 2 weeks. In the AD study, treatment success was determined using a composite end point requiring an Investigator's Static Global Assessment (ISGA) score of 0 or 1, erythema score of 0 or 1, induration/papulation score of 0 or 1, and improvement in the ISGA score of at least two grades from baseline. Likewise, the study in plaque-type psoriasis used a composite end point requiring an ISGA score of 0 or 1, erythema score of 0 or 1, scaling score of 0 or 1, plaque thickness score of 0, and improvement in the ISGA score of at least two grades from baseline. RESULTS: Significantly more participants achieved treatment success on clobetasol foam than vehicle foam (P < .0001 and P = .0005 for each study). Reversible hypothalamic-pituitary-adrenal axis suppression was observed in 27% of participants aged 18 years or older and 47% in participants aged between 6 and younger than 12 years, but 0% in participants aged between 12 and younger than 18 years. LIMITATIONS: The studies evaluated short-term use only. CONCLUSION: Clobetasol emulsion formulation foam is safe and effective for treatment of moderate-to-severe AD and mild-to-moderate plaque-type psoriasis in patients aged 12 years or older.
Skin Pharmacol Physiol. 2008; 21(3): 181-7
Borelli C, Gassmueller J, Fluhr JW, Nietsch KH, Schinzel S, Korting HC
INTRODUCTION: We report on a double-blind, vehicle-controlled, single-center confirmatory study with random assignment. The purpose of the study was to investigate the topical bioavailability of different topical corticosteroid formulations in healthy human beings focussing on desoximetasone (DM). MATERIALS AND METHODS: Two DM 0.25% formulations [ointment (DM-o) and fatty ointment (DM-fo, water-free); class III corticosteroids], the corresponding active ingredient-free vehicles and three comparators of different strength [clobetasol propionate 0.05% (CP 0.05%), fatty ointment, class IV; hydrocortisone (HC) 1%, fatty ointment, class I, and betamethasone (BM) 0.05%, fatty ointment, class III] were tested using the vasoconstriction assay. The degree of vasoconstriction (blanching) in the treatment field was compared to the one found in untreated control fields using chromametric measurements and clinical assessment. RESULTS/CONCLUSION: DM-o 0.25%, DM-fo 0.25% and BM 0.05% showed similar vasoconstrictive potential, i.e., clear blanching. In fact, both DM preparations were proven to be noninferior to BM 0.05%, while CP 0.05% was found a little less active. HC 1.0% and the DM vehicles showed no clear-cut vasoconstrictive effect. No adverse events related to the study medications were observed. Good topical bioavailability of both DM formulations was detected by chromametric measurement and clinical assessment.
Interstitial granulomatous dermatitis in a patient with rheumatoid arthritis on etanercept.
Cutis. 2008 Apr; 81(4): 336-8
Hu S, Cohen D, Murphy G, Mody E, Qureshi AA
Tumor necrosis factor-alpha (TNF-alpha) has been implicated in the pathogenesis of numerous inflammatory conditions, possibly facilitating the induction and maintenance of these diseases through lymphocyte activation and cytokine production. Inhibitors of TNF-alpha have proven efficacious in the treatment of autoimmune diseases such as psoriasis, rheumatoid arthritis, inflammatory bowel disease, and lymphoproliferative disorders. However, recent cases of adverse cutaneous reactions have been reported in anti-TNF-alpha therapy, most notably those of granulomatous morphology. We report a patient with rheumatoid arthritis who had been treated with etanercept (50 mg/wk) for 6.5 years. The patient subsequently developed pink and red papules on large areas of the upper and lower extremities. Skin biopsy specimens revealed both poorly formed and well-circumscribed nonnecrotizing epithelioid granulomas in the superficial dermis. Application of clobetasol propionate ointment 0.05% without discontinuation of anti-TNF-alpha therapy led to complete resolution of the skin lesions. While the precise mechanisms of physiologic and pathologic TNF activity remain to be determined, it is clear that granulomatous lesions may emerge as a complication of anti-TNF-alpha therapy. Treatment with topical corticosteroids may be sufficient to eliminate such lesions.
Arch Dermatol. 2008 May; 144(5): 620-4
Faurschou A, Wulf HC
OBJECTIVE: To examine the effect of topical corticosteroid treatment on acute sunburn. DESIGN: Randomized, double-blind clinical trial. SETTING: University dermatology department. PATIENTS: Twenty healthy volunteers with Fitzpatrick skin types I (highly sensitive, always burns easily, tans minimally) through III (sun-sensitive skin, sometimes burns, slowly tans to light brown). INTERVENTION: Seven 34-cm(2) areas were marked on the upper aspect of the back of each participant. An untreated area was tested to determine UV sensitivity. Two areas were treated with excess amounts (2 mg/cm(2)) of either a moderate-potency corticosteroid or a high-potency corticosteroid 30 minutes before UV-B exposure as controls. Six or 23 hours after exposure to radiation, the remaining areas were treated with the 2 corticosteroid preparations. MAIN OUTCOME MEASURES: The sunburn improvement factor (SIF) was determined by the following equation: SIF = MED (minimal erythema dose) on treated skin/MED on nontreated skin. An SIF greater than 1 indicated an effect of topical corticosteroids in sunburn relief. RESULTS: The SIFs in the areas treated with either topical corticosteroid 30 minutes before UV-B exposure or high-potency corticosteroid 6 hours after UV-B exposure were significantly different from SIFs in areas that received no treatment (SIF 1.1-1.7; P < .05). Only the median SIF of 1.7 in the areas treated with high-potency corticosteroid 30 minutes before UV-B exposure was clinically relevant. The areas treated 23 hours after UV-B exposure and the areas treated with a moderate-potency corticosteroid 6 hours after UV-B exposure showed no significant reduction in redness. CONCLUSION: Treatment with topical moderate-potency or high-potency corticosteroids does not provide a clinically useful decrease in the acute sunburn reaction when applied 6 or 23 hours after UV exposure.
J Pharm Pharm Sci. 2008; 11(1): 160-6
Au WL, Skinner M, Kanfer I
PURPOSE: The assessment of the degree of skin blanching following the application of a formulation containing a topical corticosteroid has been established as a surrogate method for the determination of bioequivalence.In this study, both visual and chromametric assessments have been carried out on two topical creams containing clobetasol propionate (0.05%) and the results from both methods are compared. METHODS: Human subjects (volunteers) were screened using a cream containing 0.05%clobetasol propionate, in order to identify appropriate subjects for inclusion in the study. The study was implemented according to the FDA guidance using both visual and chromameter assessment techniques. Blanching responses were assessed visually by three trained, independent observers and instrumentally using a Chromameter. An ED50 of 36 min was used as the dose duration based upon data previously obtained from a pilot study using the same topical corticosteroid reference product. A visual rating scale of 0-4 and the a-scale readings from the chromameter were used. RESULTS: The visual and chromameter blanching profiles showed similar blanching responses with good correspondence. The 90% confidence intervals for the data from both methods were calculated using Locke's method. When only the data obtained from 23 subjects who were identified as"detectors" (as per FDA guidance) were used, the products fell within the bioequivalence acceptance range of 80-125% using the visual assessment method (99.3-111.6%) whereas the data using a chromameter (86.5-129.3%) were just outside the acceptance limits. However, when all subjects (n=34) were included in the calculations, both the visual (97.9-109.2) and chromameter (90.2-120.7) data fell within the bioequivalence acceptance range.CONCLUSIONS: Whereas visual data indicated bioequivalence using either data from "detectors" or data from all subjects, the chromameter data from "detectors" only indicated bioinequivalence but inclusion of all subject data fell within the acceptance range to be declared bioequivalent.
Nail psoriasis: a combined treatment with 8% clobetasol nail lacquer and tacalcitol ointment.
J Eur Acad Dermatol Venereol. 2008 Apr 10;
Sánchez Regaña M, Márquez Balbás G, Umbert Millet P
Background Nail involvement is a common and distressing feature in the course of psoriasis. Although much progress has been made in the treatment of the disease, the presence of psoriasis in the nail continues to pose a challenge. In recent years, vitamin D3 analogs and a new formulation containing 8% clobetasol-17-propionate in a colourless nail lacquer vehicle have produced good results for the control of nail psoriasis. Objective To determine the efficacy and safety of the combined treatment of 8% clobetasol-17-propionate in a lacquer vehicle and tacalcitol ointment in nail psoriasis. Methods Fifteen patients with both nail bed and nail matrix psoriasis were included in the study. They were treated with a colourless nail lacquer containing 8% clobetasol-17-propionate applied at bedtime at the weekend, and with tacalcitol ointment under occlusion on the remaining days, for 6 months. Results All 15 patients responded well to treatment. The therapeutic effect was very fast and directly related to the length of therapy. All nail alterations, including nail pain, were reduced, and the modified target Nail Psoriasis Severity Index fell by an average of 78% compared to baseline levels (+/-59.6, P < 0.0001). Conclusions Combined treatment with tacalcitol ointment and 8% clobetasol-17-propionate in a nail lacquer is a safe, effective treatment for nail bed and nail matrix psoriasis.
Time to nip "seeding trials" in the bud.
Arch Dermatol. 2008 Mar; 144(3): 403-4
Katz KA
Bullous eruption in a patient infected with the human immunodeficiency virus.
Skinmed. 2008 Mar-Apr; 7(2): 98-101
De D, Kanwar AJ, Radotra BD, Narang T
A 30-year-old man diagnosed with human immunodeficiency virus (HIV) infection 10 years earlier, presented with large tense blisters associated with minimal itching of 10 days' duration. He had no history of oral or genital erosions or ulcerations and showed no symptoms of HIV-related illnesses. Highly active antiretroviral therapy (HAART) had been started 6 weeks earlier when his CD4 count was 116/mL. He initially received nevirapine 200 mg once daily; after 2 weeks with no skin eruptions or other adverse reactions, the dose was increased to 200 mg twice daily. Other components of his HAART included lamivudine and stavudine. The patient was not taking any other prescription or alternative medicines. During the past year, he experienced 4 episodes of intensely itchy urticarial lesions that subsided with antihistamines. The present episode of bullous lesions was also preceded by urticarial lesions. On examination, he had multiple, large, tense bullae over relatively normal-looking skin involving all parts of the body (Figure 1). There were a few well-defined erosions. Nikolsky and bullae spread signs were negative, and no oral or genital erosions or ulcerations were noted. Results of a complete blood count, renal and liver function tests, and chest x-ray were within normal limits. Skin biopsy from one of the blisters showed a subepidermal bulla filled with eosinophils and polymorphonuclear leukocytes (Figure 2). The underlying dermis showed perivascular inflammatory infiltrate composed of polymorphonuclear and lymphomononuclear cells. The overall features were suggestive of bullous pemphigoid. A direct immunofluorescence test could not be done because of possible risk of cross-infection to the operator of the cryostat. Workup for herpes simplex virus and cytomegalovirus infection also could not be performed. HAART was discontinued temporarily with the suspicion that it was the causative factor. The patient was started on oral prednisolone 40 mg/d and topical clobetasol propionate (0.05%). Within 1 week of treatment, he had significant improvement with almost complete disappearance of the lesions. A few small, tense vesicles continued to appear between. Once the lesions completely disappeared, the prednisolone was gradually tapered off and all the components of HAART were resumed. The patient did well without any recurrence of lesions, thus virtually excluding HAART as the cause of the bullous pemphigoid-like eruptions. Subsequently, he did not return for follow-up.
Ulcus vulvae acutum in a 13-year-old girl after influenza A infection.
Skinmed. 2008 Mar-Apr; 7(2): 95-8
Wetter DA, Bruce AJ, MacLaughlin KL, Rogers RS
A 13-year-old otherwise healthy premenarchal girl presented with acute onset of painful vulvar ulcerations. One day before developing vulvar ulcerations, she experienced flu-like symptoms, including a low-grade fever, cough, sore throat, and myalgia. Results of a throat swab were positive for influenza A infection (polymerase chain reaction [PCR] assay), and the patient was treated with oseltamivir. The patient's constitutional symptoms improved slightly, but within 2 days after her initial presentation, she returned to her primary care provider and described 24 hours of dysuria and vulvar swelling. She had a history of herpes labialis (cold sores) and rare episodes of minor oral aphthae (canker sores) that occurred less than twice a year. The patient denied a history of sexual activity, sexual abuse, or physical trauma. Physical examination showed ulceration and swelling of the labia minora, and the patient received an empiric dose of acyclovir (200 mg 4 times daily) for presumed autoinoculated herpes simplex virus (HSV) infection. An ulcer swab was performed, and urinalysis revealed no evidence of infection. Two days later, the patient presented to the emergency department with increasing vulvar pain and vaginal discharge. The previous ulcer swab findings were negative for HSV (PCR assay), and consequently, acyclovir was discontinued after 1 day of therapy. She received topical viscous lidocaine and an empiric dose of oral fluconazole. The lidocaine provided temporary symptomatic relief. Results of DNA amplification studies were negative for Chlamydia trachomatis and Neisseria gonorrhoeae. A potassium hydroxide preparation was negative for fungi, and an ulcer swab for bacterial culture revealed usual flora. Of note, the PCR assay for Epstein-Barr virus was not performed on ulcer cells. The patient was referred to the department of dermatology, and results of a physical examination showed copious white mucoid discharge and a 2-cm ulceration of the left labia minora (Figure, panel A). Two smaller pinpoint ulcerations and swelling of the left labia minora were also noted. The lesions were clinically indistinguishable from the genital aphthous ulcers of patients with complex aphthosis (recurrent, severe aphthous ulcers on oral or genital mucosa). A diagnosis of ulcus vulvae acutum was made, and treatment was started with clobetasol 0.05% ointment (4 times daily) and lidocaine gel as needed. Four days later, the patient reported marked symptomatic improvement. Physical examination showed near resolution of the large vulvar ulceration (Figure, panel B). The patient tapered use of clobetasol ointment over the next several days until the ulcerations healed completely. Two months after her initial episode, the patient again had 3 small vulvar erosions after symptoms that included low-grade fever, malaise, and vomiting. She did not receive oseltamivir for this illness; clobetasol ointment was applied 4 times daily, and the vulvar erosions ameliorated within a few days. Her constitutional symptoms resolved without treatment. The patient has not experienced any further episodes of vulvar ulcerations in the 18 months after the most recent treatment.