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Biomedical subjects

R C Cornell

Publications and source records attributed to R C Cornell.

At least 19 recordsLinked to original sources

Clinical trials of topical corticosteroids in psoriasis: correlations with the vasoconstrictor assay.

It would be desirable to develop an alternative system to clinical studies to evaluate the potency of generic topical corticosteroids and of new formulations of existing innovator corticosteroids. The vasoconstrictor assay is a reliable method for testing potency; however, its results do not always agree with clinical studies. Psoriasis offers an ideal clinical model to evaluate corticoid potency because the ability to perform within-patient comparisons of the treatment of bilateral lesions permits meaningful comparisons with a relatively small sample size. The results of bilateral comparisons in psoriasis agreed with those of the vasoconstrictor assay in 20 of 23 comparisons of active agents and in numerous comparisons of active corticosteroids with a placebo. Eczematous dermatoses do not lend themselves well to bilateral paired comparison studies and therefore require parallel treatment studies with relatively large sample sizes to produce statistically significant comparisons.

Administration, Topical↗

Intralesional interferon therapy for basal cell carcinoma.

In a clinical trial of 172 patients at four medical centers, interferon alfa-2b (1.5 x 10(6) IU) or a placebo was injected directly into biopsy-proved noduloulcerative or superficial basal cell carcinomas three times weekly for 3 weeks, for a cumulative dose of 13.5 million IU. Efficacy of treatment was determined at 16 to 20 weeks by examination of biopsy specimens that demonstrated cure of lesions in 86% of interferon-treated patients and in only 29% of placebo-treated patients. During the treatment course and follow-up, an initial inflammatory response was observed at the treatment sites, followed by diminished erythema, improvement in overall appearance, and a decrease in size of lesions. Side effects of treatment, mainly flu-like symptoms, were usually mild and transient and occurred more commonly in the interferon-treated group. Only three patients, all in the interferon-treated group, discontinued therapy because of side effects. One year after initiation of therapy, 81% of interferon recipients and 20% of those given the placebo remained tumor free. Noduloulcerative and superficial lesions were equally responsive to treatment with interferon. For some patients with noduloulcerative or superficial basal cell carcinomas, intralesional interferon alfa-2b may be an alternative, effective treatment.

Basal Cell Carcinoma↗

Topical clobetasol-17-propionate: review of its clinical efficacy and safety.

Clobetasol-17-propionate, the most potent of currently available topical steroids as predicted by the vasoconstrictor assay, has just been approved in the United States. In psoriasis, it has proved significantly more effective than class II steroids and as or more effective than the only marketed class I steroid. In the more steroid-responsive eczemas, the superior efficacy of clobetasol is also apparent, but less striking. Clobetasol prolongs remission rates, making intermittent treatment schedules feasible and minimizing inherent potential steroid side effects. Clobetasol may also be useful in the treatment of a myriad of other skin conditions. A review of the pharmacology, efficacy, and side effects of this addition to our dermatologic armamentarium is presented here.

Administration, Topical↗

Treatment of basal cell carcinoma with intralesional interferon.

Eight patients with basal cell carcinomas were treated with recombinant alpha-2 interferon. Each patient had a biopsy-proved basal cell carcinoma of the nodular or superficial type that was injected intralesionally three times a week for 3 weeks (9 total injections) with 1.5 X 10(6) IU (0.15 ml) of alpha-2 interferon per injection (total dose, 13.5 X 10(6) IU). Excisional biopsy 2 months after completion of therapy revealed no evidence of basal cell carcinoma in any patient. Minimal side effects were observed. In these eight patients alpha-2 interferon was therefore an effective and safe modality of treatment. The encouraging results of this pilot study suggest that additional evaluation of interferon in the treatment of basal cell carcinoma is warranted.

Basal Cell Carcinoma↗

A comparison of clobetasol propionate 0.05 percent ointment and an optimized betamethasone dipropionate 0.05 percent ointment in the treatment of psoriasis.

A multicenter, double-blind study compared the effectiveness of two highly potent topical corticosteroids in patients with moderate to severe signs of psoriasis. Left/right paired comparisons of clobetasol propionate ointment 0.05 percent, and an optimized formulation of betamethasone dipropionate ointment 0.05 percent, were made in 130 patients with roughly symmetrical psoriatic lesions. The ointments were applied by the patients twice daily, without occlusion, for two weeks. Both drugs were shown to be highly effective and were well tolerated. Significantly more patients showed greater improvement on the side treated with clobetasol propionate. Follow-up evaluation two weeks after the treatment period showed statistically significant (p less than 0.001) longer remissions resulting from the use of clobetasol propionate.

Administration, Topical↗

Multicenter study comparing 0.05% gel formulations of desoximetasone and fluocinonide in patients with scalp psoriasis.

A double-blind, multicenter study was conducted to evaluate and compare the safety and efficacy of desoximetasone gel 0.05% and fluocinonide gel 0.05% in patients with scalp psoriasis. One hundred twenty-five patients were enrolled in this randomized, parallel-group trial. Responses based on clinical assessment in 123 patients showed that the desoximetasone gel formulation is a safe and effective treatment for psoriasis of the scalp. Although efficacy appears equivalent to that of fluocinonide gel 0.05% in treating psoriasis of the scalp, desoximetasone appears to be slightly better tolerated and better accepted cosmetically.

Administration, Topical↗

The effect of alclometasone dipropionate cream 0.05% on the hypothalamic-pituitary-adrenal axis of normal volunteers.

In an open study of ten evaluable normal volunteers, 30 g of alclometasone dipropionate cream 0.05% was applied to 80% of body surface each morning and evening for 21 days. A plastic body suit effectively occluded the treated area for 12 hours/day. As demonstrated by continued normal levels of 8 a.m. plasma cortisol and 24-hour urinary 17-hydroxysteroid and free cortisol, no suppression of the hypothalamic-pituitary-adrenal axis occurred. Local adverse reactions were mild and transient.

Administration, Topical↗

Correlation of the vasoconstriction assay and clinical activity in psoriasis.

A large group of glucocorticosteroid formulations were assayed by the vasoconstriction test in normal skin sites and paired comparison studies in patients with psoriasis. Excellent correlation between the vasoconstriction assay and selected paired comparison studies occurred in 20 of 23 instances. In three instances, involving two glucocorticosteroid formulations tested, correlation was absent. The vasoconstrictor assay is an inexpensive and reliable method for screening glucocorticosteroid formulations for clinical activity in psoriasis.

Administration, Topical↗

Comparison of amcinonide ointment 0.1 percent twice daily and fluocinonide ointment 0.05 percent three times daily in the treatment of psoriasis.

Thirty-nine patients with psoriasis were treated either with amcinonide ointment 0.1 percent twice a day or with fluocinonide ointment 0.05 percent three times a day in a two-week, randomized, parallel-group, double-blind study. The severities of the skin lesions at baseline and at weekly intervals and the overall improvement at weekly intervals were evaluated by the investigator and the patient. The skin lesions improved significantly (p less than or equal to 0.01) over their condition at baseline, with good overall improvement attained by both treatment groups within one week. Both treatments were well tolerated. Amcinonide ointment 0.1 percent applied twice a day was found to be as effective and acceptable to patients as was fluocinonide ointment 0.05 percent applied three times a day in the treatment of psoriasis.

Double-Blind Method↗

Six-month controlled study of effect of desoximetasone and betamethasone 17-valerate on the pituitary-adrenal axis.

Twenty-two patients were treated with desoximetasone emollient cream 0.25% twice daily without occlusion for 6 months. Patients applied the medication to approximately one-third of their body over psoriatic lesions. Corticosteroid plasma cortisol values decreased to below normal limits in nine patients before the 6-month study was terminated. In four of these the plasma cortisol spontaneously returned to normal despite therapy; in four other patients, however, the plasma cortisol was still suppressed at the end of 5 months of continual therapy but returned to normal within 7 days of discontinuation of the medication. In one patient, lost to further follow-up at 5 1/2 months of therapy, the trend at the fourth month was an increase in plasma cortisol to within one unit of normal range. Betamethasone 17-valerate 0.1% cream applied twice daily did not suppress plasma cortisol in twenty-three patients similarly tested. The clinical response to desoximetasone emollient cream was significantly better than to betamethasone valerate cream. This study closely approximates the way in which many patients with steroid-responsive dermatoses use potent topical steroids, namely over a long time period and without occlusion.

Adolescent↗

A clinical screening program for topical chemotherapeutic drugs in psoriasis.

In this national, multicenter cooperative study, a standardized drug screening program was designed and evaluated to test the clinical effectiveness of 30 topically applied chemotherapeutic drugs to psoriasis. Appropriate concentrations and vehicles for topical administration were selected with regard to clinical testing consisted of a double-blind application of test agents to psoriatic plaques under occlusion daily for up to nine days. Drugs known to be topically active in psoriasis, eg, thiotepa, fluorouracil, and betamethasone valerate, were easily detected in the clinical protocol, confirming the validity of this topical drug screening program. Seven drugs produced substantial clinical improvement with evidence of clearing; nine drugs produced slight improvement; 14 drugs had no effect. No systemic toxid reactions occurred. This screen should be useful to test other potential antipsoriatic drugs and to evaluate potential animal model screens for their predictive values with the same drugs.

Adult↗

Double-blind comparison of topical 1 percent clindamycin phosphate (Cleocin T) and oral tetracycline 500 mg/day in the treatment of acne vulgaris.

An eight week double-blind study comparing 1 percent clindamycin phosphate (Cleocin T) applied topically with tetracycline 500 mg a day taken orally was conducted in fifty subjects. Topically applied 1 percent clindamycin phosphate was found to be superior to oral tetracycline at six weeks as judged by patient evaluation and reduction of papules. There was a consistent trend favoring clindamycin phosphate at the other visits but the difference was not significant. The use of topically applied 1 percent clindamycin phosphate seems to be a logical alternative to the use of oral tetracycline.

Acne Vulgaris↗

Laboratory induction and clinical occurrence of combined clindamycin and erythromycin resistance in Corynebacterium acnes.

Corynebacterium acnes strains cross-resistant to clindamycin and erythromycin were observed following long-term selection or mutagenic treatment in the laboratory. Similar strains were found among clinical isolates from patients using clindamycin or erythromycin topically in the treatment of acne vulgaris. Clindamycin resistance was never observed in the absence of resistance to macrolides or other lincosaminides. It is suggested that this resistance may result from an alteration of the 50S ribosomal subunit.

Clindamycin↗

Plasma complement and histamine changes in atopic dermatitis.

Fifteen patients with atopic dermatitis were investigated to evaluate the total of complement and histamine. In five patients total serum complement haemolytic activity (CH50) was significantly decreased as was the haemolytic activity of complement components C2 (C2H50) and C3 (C3H50). By counter immunoelectrophoresis split products of C3 were detected. There was no evidence for alternative pathway activation or the presence of an activator of the alternative pathway. In three patients plasma histamine concentrations were elevated. The intensity of the complement and histamine changes observed seemed to be correlated to the severity of the disease.

Adolescent↗

Complement and immunoglobulin deposits in the skin of patients with atopic dermatitis.

The immunofluorescent patterns of uninvolved and involved skin biopsies from eight patients with atopic dermatitis were studied, using direct immunofluorescence techniques to identify deposits of the immunoglobulins G, A and M as well as the complement factors C1q, C3, C4, C5, factor B and properdin. Immunoglobulin deposits (mainly IgG) were found in five patients, complement deposits in three patients in the basement membrane zone. In three patients the immunofluorescence was positive for C3, in two patients for C1q, C4 and C5. Regarding the factors of the alternative pathway of the complement system, two patients showed deposits of properdin, one of factor B. The changes were not confined to the eczematous lesions, but were found in uninvolved skin too. The most prominent changes were observed in patients with severe disease.

Adolescent↗

New cream vehicle for flurandrenolide.

New methods are now available to help select vehicles for topical corticosteroids. In the development of a new cream vehicle for flurandrenolide, the goal was a cream base with optimal solubility for release of the drug, minimal irritation potential, and no sensitizing preservatives. Vasoconstriction tests make selection much more scientific, and a newer method for such testing is described in detail. Irritation testing then helped determine the vehicle concentration that was least irritating. Final studies included double-blind comparisons with the previous formulation in the treatment of psoriatic patients.

Biological Availability↗