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At least 865 records · Page 48Linked to original sources
PubMedDate not supplied

[Clinical trials in dermatology. The phase I trials].

Application of the new topical product on the diseased skin should be preceded by its safety evaluation on the healthy skin in human volunteers. We propose here guidelines for the evaluation of the irritation, sensitization, phototoxicity and photoallergy potentials for topical products. The methods for evaluation of percutaneous absorption are also discussed. The studies presented here are not the object of any regulations. Therefore, we propose here an approach for the safety evaluation of topical products in human volunteers.

Administration, Topical↗
PubMedDate not supplied

[Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical anti-inflammatory treatment in atopic dermatitis].

Study designs for assessment of topical anti-inflammatory drugs in atopic dermatitis are discussed. Atopic dermatitis is a chronic disease with symmetrically distributed lesions. In order to avoid individual and spontaneous variation and to obtain an early impression of the efficacy of a new topical drug, bilaterally paired lesions can be used. Further drug development requires controlled double-blind parallel group design. General recommendations regarding inclusion criteria, and the measurement of efficacy and safety parameters are presented. Methods available for data evaluation and the particularities of different clinical designs are discussed.

Administration, Topical↗
PubMedDate not supplied

[Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical antipsoriatic treatment].

There has been considerable variations between different authors in the evaluation of antipsoriatic therapies. Improvement homogeneity must be achieved in this field. The main specific methods have been investigated: inclusion criteria, assessment of disease progress and safety parameters in phase II and III clinical trials, evaluating antipsoriatic treatment.

Administration, Topical↗
PubMedDate not supplied

[Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical antifungal agent in the treatment of superficial mycoses].

There is no single method for evaluating topical antifungal drugs. The localisation and the type of fungal, determine the treatment duration (from few days to several months). The main methodological characteristics of clinical trials in tinea pedis treatment (athlete's foot type) are reported. Aspects related to other clinical forms such as tinea versicolor and onychomycosis are also described. In any case, the main criteria of activity remains the mycological examination based on KOH microbiology and culture performed at the end of the treatment and again afterwards.

Administration, Topical↗
PubMedDate not supplied

[Clinical trials in dermatology. Statistical support].

To determine the efficacy or safety of new topical treatments, more or less standardized studies must be performed. This article presents several examples of statistical analyses of the data currently seen in the dermatology area, and some guidelines for study sample size determination. More importantly, it indicates, for as soon as phase I studies, the need for preliminary informations such as development strategy, historical data, literature references or pilot studies, to determine or adapt appropriate designs and sample sizes. This need can be filled by close collaboration among clinicians, statisticians and sponsor.

Clinical Trials as Topic↗
PubMed1991

[Studies of the changes in crystalline lens transparency in rabbits with experimental cataract].

Changes of the transparency of lenses were checked by means of in vivo spectrophotometry of the eye ball and by light transmission through extracted lenses in the course of experimental early cataract in rabbits caused by naphthalen. The results of investigations show that changes of lens transparency evaluated by means of in vivo spectrophotometry of the eye appear earlier than the clinically seen opacity. It speaks for the advisability of undertaking of further studies on the possibility of utilizing this method for detection of precataractous conditions in humans.

Absorption↗
PubMed1991

[Studies of the changes in crystalline lens transparency in subjects at risk of developing cataract].

The aim of the survey was a comparison of transparency of the lenses examined by means of in vivo spectrophotometry of the eye in metalurgists threatened by development of cataract--with the results obtained in persons not engaged in metalurgy and selected by chance from the population. The investigations showed that the transparency of the lenses was lower in the group of the metalurgists than in the control group in spite of the fact that the ophthalmological examination did not detect any lens changes. The results of this study show that the in vivo spectrophotometry may find some employment for detection of changes in the lens which may occur in persons threatened by development of cataract.

Adult↗
PubMed1991

[Acne fulminans triggered by isotretinoin therapy].

An 18-year old male patients with tetracycline-resistant acne vulgaris was prescribed isotretinoin in daily doses of 0.5 mg/kg. Ten days later, he developed an acute episode of acne fulminans which was regressive. Subsequently, two attempts were made at reintroducing isotretinoin; the first one was followed by a new episode of acne fulminans and the second one, by ordinary myalgias, while the patient was still under corticosteroid therapy. A search in the literature yielded 14 cases of acne fulminans that had possibly been induced by isotretinoin. Doses and intervals between medication and acute manifestations varied, and the responsibility of isotretinoin was seldom demonstrated. Associations with erythema nodosum myalgias and arthralgias have been described. This rare adverse effect of isotretinoin therapy must be known. Its course and treatment are not different from those of ordinary acne fulminans.

Acne Vulgaris↗
PubMedDate not supplied

[Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical anti-acne].

Acne is a frequent dermatologic disease of the teenagers. Methodology of antiacne preparations clinical trials has evolved recently, leading to better comprehension of acne treatment on acne lesions. The main rules for good clinical evaluation of acne treatments are: an objective counting of each individual lesions on a defined area (face, back), a global acne assessment, a therapy duration from 1 to 3 months or more, a skin safety evaluation for erythema, desquamation, dryness, itching, burning and oiliness with a 0 to 3 scoring system.

Acne Vulgaris↗
PubMed1991

Comparison of the effects of intravenous almitrine and positive end-expiratory pressure on pulmonary gas exchange in adult respiratory distress syndrome.

The effects of almitrine on pulmonary gas exchange and haemodynamics were compared to those of positive end-expiratory pressure (PEEP) in 10 patients with a severe adult respiratory distress syndrome (ARDS) who required continuous mechanical ventilation. Haemodynamic and gas exchange measurements were made before and after 30 min of PEEP at a level of 10 cmH2O, then 30 min later, before and at the end of the intravenous infusion of almitrine at a dose of 0.25 mg.kg-1 in 30 min. There was no significant difference between baseline gas exchange and haemodynamic parameters. PEEP and almitrine increased Pao (p = 0.001) from 10.9 to 12.6 kPa and from 10.6 to 12.6 kPa (1 kPa = 7.5 mmHg), respectively, and ratio of venous admixture to total blood flow (Qs/Qt) decreased (p less than 0.001) from 34 to 29% and from 33 to 29%, respectively, the effects of PEEP and almitrine being not significantly different. Neither PEEP nor almitrine caused a significant change in arterial carbon dioxide tension (PaCO2). The haemodynamic parameters did not change significantly with almitrine, whereas mean systemic arterial pressure decreased from 85.4 to 81.1 mmHg (p less than 0.05) with PEEP. These results are consistent with the hypothesis that both treatments improve ventilation/perfusion (VA/Q) distributions, by an increase in functional residual capacity in the case of PEEP and a redistribution of pulmonary perfusion in the case of almitrine.

Adult↗
PubMed1991

Transient intraepidermal bullous reaction after skin graft for toxic epidermal necrolysis. Ultrastructural and immunohistochemical features similar to those of inherited epidermolysis bullosa simplex.

Blister formation in skin graft donor or recipient sites is uncommon. We describe a 49-year-old female patient with bullae in sites of grafts used in the treatment of toxic epidermal necrolysis. Generalized loss of skin developed 3 weeks after she had ingested phenobarbital. Sixty days after the beginning of the toxic epidermal necrolysis, the reepidermization was only 80% and skin grafts were placed on lower-extremity and abdominal wounds using the first healed sites as donor sites. Several bullae and erosions were noted on grafted areas 3 weeks later. Skin biopsy specimens revealed separation at the dermoepidermal junction, and no autoantibodies were detected by direct and indirect immunofluorescence. Electron microscopy demonstrated that the blister was formed through the basal keratinocytes and that the dermoepidermal junction, including hemidesmosomes and anchoring fibrils, was normal. Immunofluorescence mapping was performed using polyclonal antibodies from the serum of patients with bullous pemphigold and epidermolysis bullosa acquisita and monoclonal antibodies against GB3 antigen and collagen type VII. All but the bullous pemphigold serum gave positive results; only faint and focal staining of the dermoepidermal junction was observed with bullous pemphigold serum. These findings are the same as those encountered in hereditary epidermolysis bullosa simplex. A biopsy performed 1 year later in the same site as the first one revealed that bullous pemphigold antigen was normally expressed. Keratinocytes autografted in the treatment of toxic epidermal necrolysis may become transiently, functionally abnormal because of the alteration of recipient sites.

Blister↗
PubMedDate not supplied

[Clinical studies of the tilted disc syndrome].

Frequency of occurrence of all clinical signs in the tilted disc syndrome was studied in the paper because of variability of clinical picture in this syndrome. The most frequently occurring signs were: tilting of the disc (89%), oblique direction of the vessels (89%) and myopic astigmatism (96%). Other signs were observed less frequently: hypoplastic changes of retina and choroid in 82%, congenital conus in 45% and defects in the visual field in 55%. All sign of the syndrome were seen in 45% od the examined eyes. The most important signs of the syndrome are: tilting of the disc, oblique direction of the vessels and congenital conus.

Adult↗
PubMedDate not supplied

[Spontaneous detachment of the preretinal membrane in preretinal macular fibrosis].

Preretinal macular fibrosis is one of the most frequently encountered conditions of the macula; it is based on the formation of a transparent or white-gray preretinal membrane. Usually these changes do not progress and persist without change for many years. In rare cases it may come to a spontaneous detachment of the preretinal membrane connected usually with an improvement of the visual acuity. Presented are 2 patients with preretinal macular fibrosis in whom--after a various duration of the disease--it came to a spontaneous detachment of the preretinal membrane.

Adult↗