Activity of different desoximetasone preparations compared to other topical corticosteroids in the vasoconstriction assay.

INTRODUCTION: We report on a double-blind, vehicle-controlled, single-center confirmatory study with random assignment. The purpose of the study was to investigate the topical bioavailability of different topical corticosteroid formulations in healthy human beings focussing on desoximetasone (DM). MATERIALS AND METHODS: Two DM 0.25% formulations [ointment (DM-o) and fatty ointment (DM-fo, water-free); class III corticosteroids], the corresponding active ingredient-free vehicles and three comparators of different strength [clobetasol propionate 0.05% (CP 0.05%), fatty ointment, class IV; hydrocortisone (HC) 1%, fatty ointment, class I, and betamethasone (BM) 0.05%, fatty ointment, class III] were tested using the vasoconstriction assay. The degree of vasoconstriction (blanching) in the treatment field was compared to the one found in untreated control fields using chromametric measurements and clinical assessment. RESULTS/CONCLUSION: DM-o 0.25%, DM-fo 0.25% and BM 0.05% showed similar vasoconstrictive potential, i.e., clear blanching. In fact, both DM preparations were proven to be noninferior to BM 0.05%, while CP 0.05% was found a little less active. HC 1.0% and the DM vehicles showed no clear-cut vasoconstrictive effect. No adverse events related to the study medications were observed. Good topical bioavailability of both DM formulations was detected by chromametric measurement and clinical assessment.

Topical fulvestrant solution has no effect on male and postmenopausal female androgenetic alopecia: results from two randomized, proof-of-concept studies.

BACKGROUND: Androgenetic alopecia (pattern baldness) affects approximately half of all white-skinned men and women over the age of 40 years. Based on preclinical studies in mice in which topical fulvestrant (ICI182,780, an anti-oestrogen) caused telogen hair follicles to enter anagen, thereby causing hair growth, a topical formulation of fulvestrant was developed for the potential treatment of androgenetic alopecia. OBJECTIVES: To evaluate the efficacy of fulvestrant solution in stimulating hair growth in men and postmenopausal women with androgenetic alopecia in two randomized, phase II, minoxidil- and/or vehicle-controlled studies. METHODS: One hundred and two white-skinned men aged 18-50 years with Norwood/Hamilton grades III, IIIv, IV, V or Va androgenetic alopecia received topical fulvestrant 70 mg mL(-1) solution, vehicle or minoxidil 2% solution twice daily for 16 weeks. Seventy postmenopausal women with Ludwig grade 1 or 2 androgenetic alopecia received topical fulvestrant 70 mg mL(-1) solution or vehicle twice daily for 16 weeks. The endpoints in both studies were hair density, cumulative hair thickness and hair growth rate, measured by TrichoScan analysis of digital images. RESULTS: There were no statistically significant differences favouring fulvestrant over vehicle at study end (day 113) for any of the efficacy parameters in men or women. Statistically significant differences in favour of minoxidil over fulvestrant were seen from day 57 onwards for hair density, cumulative hair thickness and hair growth rate in men. CONCLUSIONS: These results indicate a lack of effect of topical fulvestrant in the treatment of subjects with androgenetic alopecia. The reasons for this lack of effect remain unclear.

Anti-inflammatory efficacy of topical preparations with 10% hamamelis distillate in a UV erythema test.

In 40 volunteers the efficacy of three lotions with 10% hamamelis distillates from different suppliers, two vehicles, dimethindene maleate 0.1% gel, hydrocortisone 1% cream and hydrocortisone 0.25% lotion were investigated in a modified UV erythema test with three UV dosages (1.2, 1.4 and 1.7 MED). The test preparations were applied occlusively over a 48-hour period following irradiation. Chromametric measurement of redness and visual assessment were performed 24, 48 and 72 h after induction of erythema. The hydrocortisone formulations were most effective in erythema suppression. An anti- inflammatory effect was noted for all three hamamelis lotions as well as for the vehicles. A significantly greater suppression of erythema than seen with the vehicles was noted for one of the hamamelis lotions at 1.4 MED. The efficacy of the antihistamine dimethindene maleate did not surpass the hamamelis lotions or the vehicles. Even though the differences between the hamamelis lotions were slight, it was possible to make an objective selection of the best hamamelis distillate for aftersun purposes.

Treating hypertrophic scars for 12 or 24 hours with a self-adhesive hydroactive polyurethane dressing.

Treatment with a self-adhesive hydroactive polyurethane dressing (Cutinova thin, Beiersdorf AG, Hamburg, Germany) applied over a period of eight weeks has been shown to have a beneficial effect on hypertrophic scars. However, the use of such dressings during the daytime on visible parts of the body is often problematic and might lead to reduced compliance. In the present study the effect of 12-hour (overnight) treatment was compared with the results of a 24-hour treatment regimen with the same dressing. The dressings were applied over an eight-week period. Evaluation of the hypertrophic scars was by clinical assessment and measurement of colour difference to normal skin, elevation and elasticity. In addition, the patients assessed the treatment effects (questionnaire) and photographs were taken. Under both regimens an improvement in the scar colour (redness) and visual assessment scores took place. The patients also gave a positive assessment of the effects of the treatment. After eight weeks there were no relevant differences between the scars treated with the self-adhesive dressings for 12 hours (overnight) and those treated for 24 hours per day.

Anti-inflammatory effect of hamamelis lotion in a UVB erythema test.

BACKGROUND: Although Hamamelis virginiana has long been used in the traditional treatment of skin diseases, there are few controlled clinical studies defining the extent of its anti-inflammatory action. OBJECTIVE: The anti-inflammatory efficacy of pH5 Eucerin aftersun lotion with 10% hamamelis distillate, the vehicle and a prior aftersun formulation were tested in 30 healthy volunteers using a modified UVB erythema test as model of inflammation. METHODS: Four UVB doses ranging from 1 to 2 MED were evaluated in each subject. Test fields on the back were treated occlusively for 48 h following irradiation. Chromametry and visual scoring were used to determine the degree of erythema in the treated fields and an untreated, irradiated control field 7, 24 and 48 h after irradiation. RESULTS: Erythema suppression ranged from approximately 20% of 7 h to 27% at 48 h in the hamamelis fields. A suppression of 11-15% was recorded in the fields treated with the other lotions. Significant differences were noted between hamamelis and these lotions. CONCLUSION: These data provide evidence for an anti-inflammatory action of the aftersun lotion with 10% hamamelis and support the usefulness of the UVB erythema test with multiple UV doses for the testing of nonsteroidal anti-inflammatory agents.