The Non-Human Primate in Safety Assessment of a Bifunctional Long-Acting Insulin Analogue.

Species selection plays a pivotal part during non-clinical safety assessment in drug development. If possible, use of non-human primates (NHPs) should be avoided due to ethical considerations. However, limiting factors as lack of pharmacologic activity in other species could necessitate use of NHPs.

Alginate and Nanocellulose Dressings With Extract From Salmon Roe Reduce Inflammation and Accelerate Healing of Porcine Burn Wounds.

Partial-thickness thermal burn wounds are characterized by a prolonged inflammatory response, oxidative stress, tissue damage, and secondary necrosis. An optimal dressing for burn wounds would reduce inflammation and oxidative stress while providing a moist, absorbent, and protective cover. We have developed an extract from unfertilized salmon roe containing components with potential anti-inflammatory and antioxidative properties, called HTX.

Non-clinical safety assessment of single and repeated intramuscular administration of a human papillomavirus-16/18 vaccine in rabbits and rats.

The human papillomavirus (HPV)-16/18 vaccine (Cervarix®) is a prophylactic vaccine for the prevention of cervical cancer. The vaccine contains recombinant virus-like particles assembled from the L1 major capsid proteins of the cervical cancer-causing viral types HPV-16 and HPV-18, and Adjuvant System 04 (AS04), which contains the immunostimulant MPL and aluminium salt. To evaluate potential local and systemic toxic effects of the HPV-16/18 vaccine or AS04 alone, three repeated-dose studies were performed in rabbits and rats.

Occupational contact dermatitis in painters: an analysis of patch test data from the Danish Contact Dermatitis Group.

Background: Painters are among the occupational groups that most commonly experience occupational contact dermatitis, but few investigations exist concerning this occupation.

Objectives: To characterize painters with contact dermatitis and identify the most common allergens associated with the occupation. Materials and methods.

Contact allergy to epoxy resin: risk occupations and consequences.

Background: Epoxy resin monomers are strong skin sensitizers that are widely used in industrial sectors. In Denmark, the law stipulates that workers must undergo a course on safe handling of epoxy resins prior to occupational exposure, but the effectiveness of this initiative is largely unknown.

Objectives: To evaluate the prevalence of contact allergy to epoxy resin monomer (diglycidyl ether of bisphenol A; MW 340) among patients with suspected contact dermatitis and relate this to occupation and work-related consequences.

Classification of hand eczema: clinical and aetiological types. Based on the guideline of the Danish Contact Dermatitis Group.

Background: No generally accepted classification scheme for hand eczema exists. The Danish Contact Dermatitis Group recently developed a guideline defining common clinical types and providing criteria for aetiological types.

Objectives: To test the concepts of this guideline in a group of hand eczema patients.

Deodorants are the leading cause of allergic contact dermatitis to fragrance ingredients.

Background: Fragrances frequently cause contact allergy, and cosmetic products are the main causes of fragrance contact allergy. As the various products have distinctive forms of application and composition of ingredients, some product groups are potentially more likely to play a part in allergic reactions than others.

Aim: To determine which cosmetic product groups cause fragrance allergy among Danish eczema patients.

Fragrance mix II in the baseline series contributes significantly to detection of fragrance allergy.

Background: Fragrance mix II (FM II) is a relatively new screening marker for fragrance contact allergy. It was introduced in the patch test baseline series in Denmark in 2005 and contains six different fragrance chemicals commonly present in cosmetic products and which are known allergens.

Aim: To investigate the diagnostic contribution of including FM II in the baseline series by comparing it with other screening markers of fragrance allergy: fragrance mix I (FM I), Myroxylon pereirae and hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC).

Characteristics of nickel-allergic dermatitis patients seen in private dermatology clinics in Denmark: a questionnaire study.

The use of nickel in certain consumer goods has been regulated in Denmark since 1990. The aim of this study was to reveal the clinical characteristics of nickel-allergic patients seen in seven private dermatology clinics and to identify current sources of nickel that may elicit nickel dermatitis. During 2006 to 2007, 634 patients with dermatitis aged 17-91 years were patch-tested and completed a questionnaire including a question about the occurrence of dermatitis following skin contact with ear-rings or ear-pins, watches, buttons or metal clasps (i.

Clinical severity and prognosis of hand eczema.

Background: Hand eczema (HE) is a frequent, long-lasting disease with both personal and societal repercussions. Consequently, more information is needed on factors that maintain symptoms.

Objectives: In this study, patients with HE were followed for 6 months from the first visit to a dermatologist to identify factors associated with severe disease and a poor prognosis.

Decreasing trends in methyldibromo glutaronitrile contact allergy--following regulatory intervention.

Background: The preservative methyldibromo glutaronitrile (MDBGN) has been banned, first from stay-on, and later from rinse-off cosmetics, in the EU countries because of increasing rates of contact allergy.

Objectives: To evaluate the frequency of contact allergy to MDBGN among patients patch tested by the Danish Contact Dermatitis Group just before and following regulatory decisions.

Patients/methods: The data set comprised 19 279 consecutive eczema patients patch tested from 2003-2007 with MDBGN 0.

Contact allergy to methyldibromo glutaronitrile--data from a 'front line' network.

The preservative methyldibromo glutaronitrile (MDBGN) has caused an epidemic of contact allergy in Europe. However, most data concerning contact allergy comes from hospital departments of dermatology. As a part of the primary health care sector, Danish dermatologists in private practice provide the front line of care for patients with skin diseases.

[Epoxy in occupational environment--an old acquaintance in a new dress].

This article describes a cluster of epoxy related contact dermatitis in a glassfibre reinforcement plant, using mostly preimpregnated epoxylaminate (Pre-Preg), but also fluid epoxy-products. An occupational medical and dermatological examination revealed nine of 26 cases as allergic contact eczema, 14 as toxic epoxyrelated eczema and three cases of other non-occupationally related skin diseases. The plant uses seven different epoxyresins with 15 epoxyhardeners.

Changes in the pattern of sensitization to common contact allergens in denmark between 1985-86 and 1997-98, with a special view to the effect of preventive strategies.

The objective of the present study is to describe any changes in the prevalence of sensitization to common contact allergens in patch-tested patients over a 12-year period. Attention is given to possible effects of preventive strategies introduced in Denmark regarding nickel and chromate sensitization during that period, and particular areas of concern are identified. Members of the Danish Contact Dermatitis Group collected patch-test results from consecutive eczema patients as well as information about exposures and demographic variables over a 6-month period in 1985-86.

[Aluminum allergy caused by DTP vaccine].

All children referred to two private dermatological practices from 1 Jan. 1985 to 31 Dec. 1990 who had pruritus and subcutaneous infiltrates in the areas of immunization with Di-Te-Pol vaccine were patch tested with a Finn Chamber or with 2% aqueous aluminium chloride.

Vaccination granulomas and aluminium allergy: course and prognostic factors.

21 children who had cutaneous granulomas following immunization with a vaccine containing aluminium hydroxide, and who had positive patch tests to aqueous aluminium chloride and/or to a Finn Chamber, were followed for 1 to 8 years. During the period of observation, the symptoms cleared in 5 children, improved in 11, and remained unchanged in 5. The course of the granulomas could not be correlated with sex or atopy, nor with intensity of the initial aluminium patch test.

[Reactions after MMR vaccination].

Four months after introducing routine vaccination against measles, mumps and German measles (MMR-vaccination) in Denmark, a questionnaire study of reactions in vaccinated children was carried out. There were significantly fewer reactions in children who had previously developed immunity to measles, either by having had the disease or by vaccination. The reaction frequency after MMR-vaccination of children immune to measles was no greater than that after other vaccinations.

Epidemiology of Haemophilus influenzae type b infections among children in Denmark in 1985 and 1986.

A retrospective epidemiological study of invasive Haemophilus influenzae type b infections among children in Denmark 1985 and 1986 was carried out and 226 cases were identified. Of these 93% occurred in patients younger than five, corresponding to an annual incidence of 40 cases per 100,000 children aged 0-4 years, 68% occurred in patients younger than two years of age, and 6% in patients younger than six months. The annual incidences of meningitis and epiglottis were 27 and 8 cases, respectively, per 100,000 children aged 0-4 years.