Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Enhanced Lotion Formulation of Halobetasol Propionate, 0.05% Versus Its Vehicle in Adult Subjects With Plaque Psoriasis.

Unlabelled:

Evaluation of adrenal suppression of a lipid enhanced, topical emollient cream formulation of hydrocortisone butyrate 0.1% in treating children with atopic dermatitis.

Corticosteroids are currently the first line of treatment for patients with atopic dermatitis. In the pediatric population however, the potential impact of adrenal suppression is always an important safety concern. Twenty boys and girls, 5-12 years of age, with normal adrenal function and a history of atopic dermatitis were maximally treated three times daily with a lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.

Actinic keratoses and the incidence of occult squamous cell carcinoma: a clinical-histopathologic correlation.

Background: The ability to clinically diagnose actinic keratoses (AKs) lesions has been taken for granted for some time. The importance of the malignant potential of these lesions is well known. However, a recent Phase IV, multicenter study assessing the long-term benefit of aminolevulinic acid-based photodynamic therapy provided a unique opportunity to prospectively examine the clinical histopathologic correlation of AKs.

Comparative efficacy of once-daily flurandrenolide tape versus twice-daily diflorasone diacetate ointment in the treatment of psoriasis.

Background: Flurandrenolide tape has recently been listed as a group I topical corticosteroid. There are no studies that compare this product to group I ointments in the treatment of steroid-responsive dermatoses.

Objective: Our purpose was to determine the relative efficacy of flurandrenolide (4 microg/cm2) tape versus 0.

Safety and efficacy of 0.5% podofilox gel in the treatment of anogenital warts.

Objective: To determine the safety and efficacy of a new gel formulation of podofilox in the treatment of anogenital warts.

Design: Double-blind, randomized, multicenter, vehicle-controlled investigation.

Setting: Private dermatology practices, university clinics (dermatology, gynecology, and infectious diseases), and contract research organizations.

Sunscreen intolerance. Contact sensitization, photocontact sensitization, and irritancy of sunscreen agents.

Reports of contact sensitization and photocontact sensitization induced by various sunscreening agents are reviewed. Current knowledge about the most often used sunscreening agents is summarized. The problems of cross-sensitization and sensitization in photodermatoses are discussed.

Safety and efficacy of a broad-spectrum sunscreen in patients with discoid or subacute cutaneous lupus erythematosus.

An eight-week, open-label study was conducted to test the efficacy, safety, and cosmetic acceptability of a broad-spectrum sunscreen in patients with discoid lupus erythematosus or subacute cutaneous lupus erythematosus. The sunscreen combined the ultraviolet A absorber avobenzone (Parsol 1789, Givaudan Corp) and the ultraviolet B absorber padimate O and had a sun protection factor greater than fifteen. The overall clinical disease severity decreased from 2.

Sunscreening agent intolerance: contact and photocontact sensitization and contact urticaria.

Reports in the literature of sensitization associated with many commonly used sunscreening agents including p-aminobenzoic acid (PABA), PABA derivatives, anthranilates, salicylates, cinnamates, benzophenones, and dibenzoylmethane derivatives are reviewed. Several of these case reports involved subjects with various photodermatoses, implicating enhanced sensitivity of the patient's skin to both light and chemicals. Despite the widespread use of sunscreens, the small number of published reports of contact and photocontact sensitization to these agents suggests that either such sensitization is less than commonly perceived or is underreported.

Serum concentration and dose-response relationships for carprofen in rheumatoid arthritis.

Thirty-eight patients with active, definite, or classical rheumatoid arthritis were tested in a double-blind, 3-week-per-arm, multiple-crossover, randomized, block-design comparison of 100, 300, 600, and 800 mg/day carprofen given b.i.d.

Changes in salicylate serum concentration and metabolism during chronic dosing in normal volunteers.

Steady-state serum salicylic acid (SA) concentrations and the formation rates of salicyluric acid (SU), salicylphenolic glucuronide (SPG), salicylacyl glucuronide (SAG), and gentistic acid (GA), and the excretion rate of unchanged SA were determined in three normal subjects following the administration of a single oral dose of acetylsalicylic acid (ASA) 37 mg kg-1 and during multiple dosing with ASA 56 mg kg-1 day-1. Steady-state SA concentrations fell 23 per cent during the 4-week study period (mean +/- SD: 239 +/- 35 to 183 +/- 23 micrograms ml-1; p less than 0.05).

Serum concentrations of salicylate and naproxen during concurrent therapy in patients with rheumatoid arthritis.

The kinetic interaction between salicylate and naproxen was investigated in 25 rheumatoid arthritis patients. Kinetic interactions were tested in serum after patients had been on each drug regimen for 1 month. Salicylate decreased serum naproxen concentration from 89.

Indoor and outdoor efficacy testing of a broad-spectrum sunscreen against ultraviolet A radiation in psoralen-sensitized subjects.

The efficacy of a sunscreen containing an investigational drug, butyl methoxydibenzoylmethane in combination with padimate O against the erythemogenic effect of ultraviolet A (UVA) radiation was evaluated in two double-blind studies involving subjects sensitized with topical 8-methoxypsoralen. UVA radiation was supplied from either a filtered solar simulator (indoors) or filtered sunlight (outdoors). Five formulations were tested: 3% butyl methoxydibenzoylmethane and 7% padimate O, 7% padimate O, 5% octyl salicylate, and 3% oxybenzone, 3% butyl methoxydibenzoylmethane alone, 7% padimate O alone, and vehicle.

A strategy for reaching therapeutic salicylate levels in patients with rheumatoid arthritis using standardized dosing regimens.

After one to 2 weeks of 45 mg/kg/day choline magnesium trisalicylate (CMT) in 2 divided doses, 51 of 71 patients with rheumatoid arthritis (72%) had observed steady state serum salicylate concentrations between 150 and 300 mg/l (mean salicylate: 213 +/- 10 mg/l), although 17 later required dose adjustment. CMT dosing was changed in 37 cases by using the formula: dosing rate = total clearance X concentration. The expected and observed concentrations were not different (p = 0.

Recurrent herpes labialis in skiers. Clinical observations and effect of sunscreen.

Recurrent orofacial herpes infection may be triggered by high altitude skiing, presumably because of solar ultraviolet radiation exposure. Six (12%) of a group of 51 subjects with a history of skiing-triggered herpes observed during 1 week of high altitude skiing experienced reactivations of orofacial herpes a median of 3 1/2 days after exposure. Within this group, application of a sunscreen with a sun protection factor (SPF) of 15 failed to influence the reactivation rate as compared with a placebo.

Efficacy of a sunscreen containing butyl methoxydibenzoylmethane against ultraviolet A radiation in photosensitized subjects.

Topical formulations containing a new chemical entity, the ultraviolet A absorber Parsol 1789 (butyl methoxydibenzoylmethane), were evaluated as agents for protecting human skin against ultraviolet A (UVA) radiation. Healthy subjects were photosensitized to UVA radiation by ingestion of 8-methoxypsoralen (0.6 mg/kg).

Metabolism of salsalate in normal subjects.

The metabolism of salsalate (I) was characterized in two normal volunteers. The drug was almost completely absorbed and was excreted primarily in the urine; only approximately 1% of the total dose was found in the stools. Although I is a salicylate derivative, which on hydrolysis yields two molecules of salicylic acid (II), approximately 7-10% of the dose was not hydrolyzed to salicylic acid and appeared in the urine either as unchanged drug or glucuronide conjugates.

Tiflamizole elimination from plasma in rheumatoid arthritis.

Tiflamizole is a fluorinated diarylamidazole sulfone nonsteroidal anti-inflammatory drug not metabolized or excreted in urine. Its mean (+/- SD) elimination t 1/2 from plasma was 21.6 +/- 9 days (range 11.

Comparative pharmacokinetics of triethylphosphine gold (auranofin) and gold sodium thiomalate (GST).

The pharmacokinetics of gold sodium thiomalate (GST) and triethylphosphine gold (auranofin; AF) are different. Gold sodium thiomalate (GST) is completely bioavailable while only 15-25% of auranofin (AF) is absorbed. Protein binding of AF occurs to a larger extent to macroglobulins than does GST and total body retention of GST is much greater than AF at six months (30% versus approximately 1%).

Comparison of tolmetin kinetics in rheumatoid arthritis and matched healthy controls.

We could find no significant differences in the kinetics of tolmetin when comparing five rheumatoid arthritis patients with moderate disease activity with a carefully matched group of normal healthy volunteers. Further, there were no discernible clinically significant differences in the kinetics of tolmetin when comparing a single dose to one week of therapy. These results, although limited by the small number of subjects involved and the large interpatient variability, suggest that it may be possible to extrapolate pharmacokinetic data from normals to patients with moderately active disease.

Availability of salicylate from salsalate and aspirin.

Salicylate availability from salsalate (SSA) and aspirin (ASA) was examined in six rheumatoid arthritis patients in a multiple-dose double-blind crossover study. Doses contained equimolar amounts of salicylic acid. After initial ASA treatment to achieve therapeutic salicylate levels (150 to 300 micrograms/ml) the patients received equimolar doses of SSA or ASA.

Clinical pharmacology of tolmetin: comparisons in rheumatoid arthritis patients and normal volunteers.

The pharmacokinetics of tolmetin sodium were studied in five patients with rheumatoid arthritis (RA) and five normal volunteers to determine whether data derived from normals could be applied to RA patients. In addition, prostaglandin E (PGE) levels in synovial fluid were compared with tolmetin levels in serum and synovial fluid. Both groups received 400 mg tolmetin every 6 hours for seven days.

Tolmetin kinetics and synovial fluid prostaglandin E levels in rheumatoid arthritis.

Tolmetin kinetics were determined in the plasma and synovial fluid of five rheumatoid arthritis patients after they had ingested tolmetin (400 mg every 6 hr) for 7 days. Tolmetin was rapidly absorbed, with average peak levels in plasma and synovial fluid occurring at 45 min and 2 hr. The drug concentration in synovial fluid was higher than that in plasma for prolonged periods, while the rates of elimination from both plasma and synovial fluid were similar.

Single dose pharmacokinetics of auranofin in rheumatoid arthritis.

Six rheumatoid arthritis (RA) patients were given 2 6 mg doses of auranofin (AF) containing Au195, 6 months apart. The radioactivity in the whole body and in plasma, urine, and stool samples was measured for 6 months after each dose. Absorption was rapid with peak plasma concentrations occurring 1.