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Biomedical subjects

J Revuz

Publications and source records attributed to J Revuz.

413 records · Page 23Linked to original sources
PubMedDate not supplied

[Per os desensitization in nickel contact eczema: a double-blind placebo-controlled clinico-biological study].

BACKGROUND: Ingestion of nickel (Ni) has been demonstrated to induce a specific state of tolerance in the guinea pig and mouse. In a pilot study conducted in 10 patients, we demonstrated that per os administration of Ni leads to reduced proliferation of specific lymphocytes and a lower number of responding lymphocytes in blood. The aim of this study was to evaluate the clinical and biological changes induced by the ingestion of Ni in a double-blinded placebo-controlled study. PATIENTS AND METHODS: Patients with nickel contact hypersensitivity were given a capsule of nickel sulfate containing 5 mg Ni (group A) or an identical placebo (group B) once a week for 7 weeks. Clinical criteria were assessed 49 days after study onset: objective measurement of lesion extent and intensity and quantitative patch tests at concentrations 2.4-0.8-0.2 and 0.05 p. 100. Likewise stimulation of specific lymphocyte proliferation and the number of circulating lymphocytes responding to Ni at limit dilutions were determined. RESULTS: Thirty patients with nickel contact eczema were included in the study, 28 women and 2 men. There was no statistical difference between the two groups for the intensity of skin lesions or their clinical course, quantitative patch tests and lymphocyte stimulation tests. Conversely, the number of circulating lymphocytes responding to Ni was significantly lower in group A than in group B at study end (p < 0.05). DISCUSSION: This double-blind placebo-controlled study confirmed that per os nickel can induce a significant reduction in the number of circulating lymphocytes responding to Ni. No other effect could be demonstrated for the clinical and biological parameters studied. These preliminary results should prompt a multicentric controlled trial including a larger number of patients with more severe lesions at inclusion and with a longer treatment duration.

Adult↗
PubMedDate not supplied

[Thalidomide].

Explore the source record for details and available documents.

Dermatologic Agents↗
PubMedDate not supplied

Update on the safety of itraconazole pulse therapy in onychomycosis and dermatomycoses.

As the use of newer antifungal agents becomes more widespread, safety issues surrounding their use have become more important. To date, the safety profile of itraconazole has been well defined by its worldwide use in 50 million patients over the past 13 years. Data from clinical practice and clinical trials indicate that the 1-week pulse regimen of itraconazole is well tolerated and associated with a favourable safety profile. Adverse events are generally mild and transient. Furthermore, a dose increase to 400 mg in the pulse regimen has had no adverse impact on safety.

Antifungal Agents↗
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↗
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↗
PubMedDate not supplied

Three novel point mutations in the keratinocyte transglutaminase (TGK) gene in lamellar ichthyosis: significance for mutant transcript level, TGK immunodetection and activity.

We have investigated 8 patients from 7 unrelated families with lamellar ichthyosis (LI) for defects in the keratinocyte transglutaminase (TGK) gene. We have characterized three novel homozygous mutations and a previously reported splice acceptor site mutation. One patient showed a C-to-T change in the binding site for the transcription factor Sp1 within the promoter region. Another patient had a Gly 143-to-Glu mutation in exon 3 and a third patient, affected with a particular form of LI sparing the four limbs, demonstrated a Val382-to-Met mutation within exon 7. These three patients exhibited drastically reduced transglutaminase activity and an absence of detectable TGK polypeptide, as assessed by immunofluorescence and immunoblotting. Northern blot analysis showed that the Sp1 site mutation was associated with profound reduction of TGK transcript levels whereas normal transcript levels were observed for the two missense mutations. We hypothesize that the Sp1 site mutation impairs transcription of the TGK gene, whereas the two missense mutations induce structural changes leading to protein instability. Linkage to TGK was excluded in another family and no evidence for TGK defect was found in 3 other patients. These results further support the involvement of TGK in some patients with LI. They identify a TGK mutation as a cause for non-generalized LI and further delineate the molecular mechanisms underlying TGK deficiency in LI.

Adult↗