X-ray micro-computed-tomography in pediatric surgery: a new tool for studying embryos.

PURPOSE: The embryology of common congenital malformations is discussed controversially. Studies are hampered by a shortage of study material and techniques which require partial or complete preparation and therewith destruction of embryos. X-ray micro-computed-tomography (µCT) is a technical opportunity keeping the embryos intact. Thus, the aim of this study was to assess the applicability of µCT in embryonic research compared to the anatomical information obtained by scanning electron microscopy (SEM). METHODS: Chicken, rat, mouse and sheep embryos, processed either for SEM studies or as whole embryos, were imaged in three-dimensional (3D) using µCT. The obtained two-dimensional (2D) digital datasets were volume rendered by tomographic reconstruction software and studied using analysis software. RESULTS: All embryos were µCT scanned without technical problems. The quality of the µCT images (image contrast, anatomical details) was excellent, but varied depending on age and species studied. µCT imaging allowed a more comprehensive anatomical/morphological analysis but showed less surface details compared to SEM. CONCLUSION: µCT is a technique suitable and innovative for pediatric surgical research, which allows detailed evaluation of entire embryos without time- and specimen-consuming micro-dissection. Samples prepared for SEM can be used for µCT and vice versa.

A multicentre, randomized, placebo-controlled trial establishing the treatment effect of TDT 068, a topical formulation containing drug-free ultra-deformable phospholipid vesicles, on the primary features of erythematotelangiectatic rosacea.

BACKGROUND: Rosacea subtype 1 (erythematotelangiectatic) is an inflammatory skin disease with limited treatment options. TDT 068, a topical drug-free gel containing ultra-deformable Sequessome vesicles, is registered for use in inflammatory skin conditions, but has not been investigated in rosacea. OBJECTIVE: This postmarketing study aimed to substantiate the effects of TDT 068 in rosacea subtype 1. METHODS: Patients aged 18-85 scoring 6-15/30 for the primary and secondary features of the rosacea standard grading system (RSGS) were enrolled. Following stratification (four females/one male) patients were randomized (2:1) to receive TDT 068 or vehicle gel for 4 weeks. Efficacy was evaluated using the patient-rated rosacea-specific quality of life (R-QOL) instrument and investigator-rated RSGS. Adverse events (AEs) were monitored throughout. RESULTS: Of the 61 randomized patients, 58 were eligible for the full analysis set per protocol. Baseline characteristics were balanced across the groups. R-QOL symptom construct scores improved slightly from baseline to Week 4 in both groups (-0.04 ± 0.51 TDT 068 vs. -0.22 ± 0.59 vehicle; P = 0.1990). Changes in R-QOL total, function and emotion construct scores at Week 4 were similar with TDT 068 and vehicle, but TDT 068 yielded numerically greater increases in total RSGS scores (-1.55 ± 1.83 vs. -0.75 ± 2.38 vehicle; P = 0.105). Non-transient erythema improved significantly with TDT 068 at Week 4 (-0.34 ± 0.63 vs. -0.05 ± 0.51 vehicle; P = 0.044), with ≥1 grade improvement in 35% of patients (vs. 15% vehicle; P = 0.039). Numerically greater improvements in transient erythema and telangiectasia were also seen with TDT 068. Three treatment-related AEs were reported but no serious AEs occurred. CONCLUSION: These data, based on investigator assessment, provide evidence for the good tolerability of drug-free TDT 068 as well as modest improvements in the symptoms of erythematotelangiectatic rosacea.