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Phase 1b, multicenter, single blinded, placebo-controlled, sequential dose escalation study to assess the safety and tolerability of topically applied AG013 in subjects with locally advanced head and neck cancer receiving induction chemotherapy.
Limaye SA, Haddad RI, Cilli F, Sonis ST, Colevas AD, Brennan MT, Hu KS, Murphy BA
(2013) Cancer 119: 4268-76
MeSH Terms: Administration, Topical, Adolescent, Adult, Aged, Antineoplastic Agents, Female, Head and Neck Neoplasms, Humans, Induction Chemotherapy, Lactococcus lactis, Male, Middle Aged, Mouth Mucosa, Mouthwashes, Stomatitis, Trefoil Factor-1, Tumor Suppressor Proteins, Young Adult
Show Abstract · Added March 7, 2014
BACKGROUND - Oral mucositis (OM) is a significant toxicity of induction chemotherapy for locally advanced head and neck cancer (LAHNC). The safety and tolerability of AG013, an oral rinse containing recombinant Lactococcus lactis secreting mucosal protectant human trefoil factor 1 (hTFF1), was evaluated in a phase 1b study in LAHNC subjects who received induction with cisplatin, 5-fluorouracil, with or without docetaxel. Preliminary efficacy data were also obtained.
METHODS - A total of 25 of 52 LAHNC subjects who were followed during induction cycle 1 developed ulcerative oral mucositis (UOM; World Health Organization grade > 2) and were randomized to AG013:placebo (5:2 ratio) for cycle 2. Dosing schedules of 1, 3, or 6 times daily were evaluated (2 × 10(11) , 6 × 10(11) , and 1.2 × 10(12) colony forming units per day, respectively). OM was evaluated daily from cycle 2, day 1 through 14, using World Health Organization criteria. Pharmacokinetic assessment was also conducted.
RESULTS - AG013 bacteria were not detected in blood. Oral live AG013 bacterial and hTFF1 levels in saliva and oral mucosa were equivalent among treatment groups. The most frequently occurring adverse events were nausea, oral pain, fatigue, diarrhea, and mucosal inflammation. Only 12% (3 of 25 adverse events), mainly nausea, were attributed to the investigational medicinal product: AG013 or placebo. Efficacy analysis showed a 35% reduction in percentage of days with UOM in AG013-subjects versus placebo. All placebo subjects experienced ≥ 2 days of UOM, whereas 29% of AG013 subjects had UOM for 0 or 1 day. AG013 use resulted in fewer unscheduled office and emergency room visits. No differences were noted in mouth and throat soreness, opioid use, or gastrostomy tube placement.
CONCLUSIONS - AG013 was safe and well tolerated. Preliminary efficacy data support further study.
© 2013 American Cancer Society.
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18 MeSH Terms
Phase II AIDS Malignancy Consortium trial of topical halofuginone in AIDS-related Kaposi sarcoma.
Koon HB, Fingleton B, Lee JY, Geyer JT, Cesarman E, Parise RA, Egorin MJ, Dezube BJ, Aboulafia D, Krown SE
(2011) J Acquir Immune Defic Syndr 56: 64-8
MeSH Terms: AIDS-Related Opportunistic Infections, Administration, Topical, Adult, Antineoplastic Agents, Female, Humans, Male, Middle Aged, Piperidines, Quinazolinones, Sarcoma, Kaposi, Single-Blind Method, Young Adult
Show Abstract · Added March 5, 2014
Using a novel blinded intrapatient vehicle control design, we conducted a phase II study of topically administered halofuginone, an angiogenesis inhibitor that inhibits collagen type-I and matrix metalloproteinases (MMPs), in patients with AIDS-related Kaposi sarcoma. Serial Kaposi sarcoma biopsies assessed treatment effects on angiogenic factors and Kaposi sarcoma herpesvirus-latency associated nuclear antigen-1 (KSHV-LANA). We observed marked heterogeneity of KSHV-LANA expression. Although the small number of subjects whose response could be evaluated precluded definitive assessment of halofuginone's efficacy, we observed a significant decrease in type-I collagen only in halofuginone-treated lesions, but no effect on MMP-2. The trial design is applicable to future studies of topical agents.
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13 MeSH Terms
Ketorolac inhibits choroidal neovascularization by suppression of retinal VEGF.
Kim SJ, Toma HS, Barnett JM, Penn JS
(2010) Exp Eye Res 91: 537-43
MeSH Terms: Administration, Topical, Animals, Anti-Inflammatory Agents, Non-Steroidal, Choroidal Neovascularization, Dinoprostone, Disease Models, Animal, Fluorescein Angiography, Ketorolac, Male, Rats, Rats, Inbred BN, Retina, Vascular Endothelial Growth Factor A, Vitreous Body
Show Abstract · Added October 9, 2013
We assessed the effect of topical ketorolac on laser-induced choroidal neovascularization (CNV), measured retinal PGE(2) and VEGF levels after laser treatment, and determined the effect of ketorolac on PGE(2) and VEGF production. Six laser burns were placed in eyes of rats which then received topical ketorolac 0.4% or artificial tears four times daily until sacrifice. Fluorescein angiography (FA) was performed at 2 and 3 weeks and retinal pigment epithelium-choroid-sclera flat mounts were prepared. The retina and vitreous were isolated at 1, 3, 5, 7, and 14 days after laser treatment and tested for VEGF and PGE(2). Additional animals were lasered and treated with topical ketorolac or artificial tears and tested at 3 and 7 days for retinal and vitreous VEGF and PGE(2.) Ketorolac reduced CNV on FA by 27% at 2 weeks (P<0.001) and 25% at 3 weeks (P<0.001). Baseline retina and vitreous PGE(2) levels were 29.4 μg/g and 16.5 μg/g respectively, and reached 51.2 μg/g and 26.9 μg/g respectively, 24h after laser treatment (P<0.05). Retinal VEGF level was 781pg/g 24h after laser treatment and reached 931pg/g by 7 days (P<0.01). Ketorolac reduced retinal PGE(2) by 35% at 3 days (P<0.05) and 29% at 7 days (P<0.001) and retinal VEGF by 31% at 3 days (P=0.10) and 19% at 7 days (P<0.001). Topical ketorolac inhibited CNV and suppressed retinal PGE(2) and VEGF production.
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14 MeSH Terms
Investigation of different formulations for drug delivery through the nail plate.
Vejnovic I, Simmler L, Betz G
(2010) Int J Pharm 386: 185-94
MeSH Terms: Acetylcysteine, Administration, Topical, Boric Acids, Cadaver, Caffeine, Chemistry, Pharmaceutical, Dimethyl Sulfoxide, Dioctyl Sulfosuccinic Acid, Drug Carriers, Ethanol, Female, Fungal Proteins, Humans, Male, Methanol, Nails, Permeability, Pharmaceutic Aids, Technology, Pharmaceutical, Urea, Water
Show Abstract · Added August 3, 2013
Topical therapies for nail diseases are limited by keratinized cells in the human nail plate. An optimal permeation enhancer would not only improve drug delivery through the nail plate, but would also open new possibilities for treating neighboring target sites if systemic circulation is reached. The aim of the present work was to identify permeation enhancers and to improve the understanding of physicochemical parameters that influence drug permeation. Caffeine served as the model drug, and formulations were prepared in water and 20% (v/v) ethanol/water solutions. Tested enhancers were urea, dimethyl sulfoxide (DMSO), methanol, N-acetyl-L-cysteine (NAC), docusate sodium salt (DSS), boric acid, and fungal proteins, such as hydrophobins. Permeability studies employed cadaver nails in modified Franz-type diffusion cells. The permeability coefficient of caffeine in ethanol/water was determined to be 1.56 E-08 cm/s and was improved to 2.27 E-08 cm/s by the addition of NAC. Formulations containing either methanol or DMSO showed the highest permeability coefficients in the range of 5-7.5 E-08 cm/s. Enhancers could be classified according to their permeation enhancement: methanol>class II hydrophobins>DMSO>followed by class I hydrophobins and urea. Ethanol at a concentration of 20% (v/v) in water did not influence swelling of nail samples. Hydrophobins are suggested to be efficient in drug delivery through the nail plate.
Copyright 2009 Elsevier B.V. All rights reserved.
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21 MeSH Terms
Effect of optical tissue clearing on spatial resolution and sensitivity of bioluminescence imaging.
Jansen ED, Pickett PM, Mackanos MA, Virostko J
(2006) J Biomed Opt 11: 041119
MeSH Terms: Administration, Topical, Animals, Dermatologic Agents, Female, Glycerol, Image Enhancement, Luminescent Measurements, Mice, Microscopy, Fluorescence, Reproducibility of Results, Sensitivity and Specificity, Skin
Show Abstract · Added January 20, 2015
In vivo bioluminescence imaging (BLI) is a powerful method of in vivo molecular imaging based on the use of optically active luciferase reporter genes. Although this method provides superior sensitivity relative to other in vivo imaging methods, spatial resolution is poor due to light scattering. The objective of this study was to use hyperosmotic agents to reduce the scattering coefficient and hence improve spatial resolution of the BLI method. A diffusing fiber tip was used to simulate an isotropic point source of bioluminescence emission (550 to 650 nm). Mouse skin was treated in vitro and in vivo with glycerol (50%, 30 min) and measurements of optical properties, and imaging photon counts were made before, during, and after application of glycerol to the skin sample. Glycerol application to mouse skin had little effect on the absorption coefficient but reduced the reduced scattering coefficient by more than one order of magnitude. This effect was reversible. Consequently, the spot size (i.e., spatial resolution) of the bioluminescence point source imaged through the skin decreased by a factor of 2 (550-nm light) to 3 (650-nm light) after 30 min. Simultaneously, an almost twofold decrease in the amount of light detected by the BLI system was observed, despite the fact that total transmission increased 1.7 times. We have shown here that multiply scattered light is responsible for both observations. We have shown that applying a hyperosmotic clearing agent to the skin of small rodents has the potential to improve spatial resolution of BLI owing to a reduction in the reduced scattering coefficient in the skin by one order of magnitude. However, reducing the scattering coefficient reduces the amount of light reaching the camera due to a reduction in the amount of multiply scattered light that reaches the camera aperture and thus reducing the sensitivity of the method.
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12 MeSH Terms
Efficacy and safety of topical selamectin to eradicate pinworm (Syphacia spp.) infections in rats (Rattus norvegicus) and mice (Mus musculus).
Hill WA, Randolph MM, Lokey SJ, Hayes E, Boyd KL, Mandrell TD
(2006) J Am Assoc Lab Anim Sci 45: 23-6
MeSH Terms: Administration, Topical, Animals, Antiparasitic Agents, Ivermectin, Male, Mice, Oxyuriasis, Oxyuroidea, Rats, Rodent Diseases
Show Abstract · Added March 5, 2014
We evaluated the efficacy and safety of topical selamectin, a novel avermectin, in eliminating naturally acquired Syphacia muris infections in rats and S. obvelata infections in mice. S. muris-positive rats were assigned randomly to 4 groups: selamectin (0.6 mg/kg), selamectin (6.0 mg/kg), fenbendazole-medicated (150 ppm) chow, and untreated. S. obvelata-positive mice were allocated into 4 groups similar to those for rats. Animals not exposed to pinworm-contaminated bedding were designated as negative controls. Treatment success was assessed weekly by anal tape impressions and by necropsy examinations at the end of week 9. Evaluations of intestinal contents at necropsy revealed that, although safe, topical selamectin was 100% ineffective in eliminating Syphacia spp. infections in rats and mice. Treatment with fenbendazole-medicated chow resulted in negative anal tape impressions beginning at week 2 in rats and week 1 in mice. Negative anal tape impressions in fenbendazole-treated animals were confirmed by negative intestinal content evaluations. Of the 2 treatments evaluated, fenbendazole-medicated chow remains an effective and practical method to eliminate pinworm infections in mice and rats.
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10 MeSH Terms
Crusted scabies: clinical and immunological findings in seventy-eight patients and a review of the literature.
Roberts LJ, Huffam SE, Walton SF, Currie BJ
(2005) J Infect 50: 375-81
MeSH Terms: Administration, Oral, Administration, Topical, Adolescent, Adult, Aged, Antiparasitic Agents, Australia, Drug Therapy, Combination, Eosinophilia, Humans, Immunocompromised Host, Immunoglobulin E, Infant, Newborn, Ivermectin, Keratolytic Agents, Leprosy, Middle Aged, Review Literature as Topic, Risk Factors, Scabies
Show Abstract · Added December 10, 2013
OBJECTIVES - To describe the clinical and immunological features of crusted scabies in a prospectively ascertained cohort of 78 patients.
METHODS - All patients requiring inpatient treatment for crusted scabies in the 'top end' of the northern territory of Australia over a 10 year period were prospectively identified. Demographics, risk factors, and immunological parameters were retrospectively compiled from their medical records and pathology databases.
RESULTS - More than half the patients with crusted scabies had identifiable immunosuppressive risk factors. Eosinophilia and elevated IgE levels occurred in 58% and 96% of patients, respectively, with median IgE levels 17 times the upper limit of normal. Seventeen percent had a history of leprosy but 42% had no identifiable risk factors. There was a decrease in mortality after the introduction of a treatment protocol consisting of multiple doses of ivermectin combined with topical scabicides and keratolytic therapy.
CONCLUSIONS - Crusted scabies often occurs in patients with identifiable immunosuppressive risk factors. In patients without such risk factors, it is possible that the crusted response to infection results from a tendency to preferentially mount a Th2 response. The treatment regime described was associated with a reduction in mortality. This is the largest reported case series of crusted scabies.
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20 MeSH Terms
Endourologic management of upper tract transitional cell carcinoma.
Clark PE, Streem SB
(2004) ScientificWorldJournal 4 Suppl 1: 62-75
MeSH Terms: Administration, Topical, Antineoplastic Agents, Carcinoma, Transitional Cell, Humans, Hysteroscopy, Laser Therapy, Practice Patterns, Physicians', Treatment Outcome, Urologic Neoplasms
Added May 27, 2014
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9 MeSH Terms
Overnight 5% lidocaine ointment for treatment of vulvar vestibulitis.
Zolnoun DA, Hartmann KE, Steege JF
(2003) Obstet Gynecol 102: 84-7
MeSH Terms: Administration, Topical, Adult, Cohort Studies, Confidence Intervals, Drug Administration Schedule, Dyspareunia, Female, Humans, Lidocaine, Middle Aged, Ointments, Pain Measurement, Patient Satisfaction, Probability, Prospective Studies, Severity of Illness Index, Treatment Outcome, Vulvitis
Show Abstract · Added March 5, 2014
OBJECTIVE - To assess the effectiveness of nightly application of 5% lidocaine ointment for treatment of vulvar vestibulitis.
METHODS - Over 17 months, we assessed women presenting to our pain clinic for evaluation of introital pain; 61 women met the criteria for vulvar vestibulitis and participated in a treatment trial. We measured daily pain and intercourse-related pain using a 100-mm visual analog scale. We compared ability to have intercourse and pain ratings before and after treatment, and investigated whether prior treatment or gynecologic comorbidities predicted response to treatment.
RESULTS - After a mean of 7 weeks of nightly treatment, 76% of women reported ability to have intercourse, compared with 36% before treatment (P =.002). Intercourse-related pain score was 39.11 (95% confidence interval [CI] 30.39, 47.83) points lower after treatment (P <.001), with a decrease of 10.37 (95% CI 3.53, 17.21) points in daily pain score (P =.004). We found no association between response to prior episodic use of lidocaine and response to nightly therapy with lidocaine ointment. Few patient characteristics predicted response to treatment; however, women with interstitial cystitis and other vulvar conditions were least likely to benefit.
CONCLUSION - Long-term, nightly application of 5% lidocaine ointment shows promise as a treatment for management of vulvar vestibulitis; a randomized, double-blind, clinical trial is warranted.
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18 MeSH Terms
An in vivo comparison of topical agents on wound repair.
Bennett LL, Rosenblum RS, Perlov C, Davidson JM, Barton RM, Nanney LB
(2001) Plast Reconstr Surg 108: 675-87
MeSH Terms: Administration, Topical, Animals, Hydrogen Peroxide, Mafenide, Povidone, Sodium Hypochlorite, Swine, Wound Healing
Show Abstract · Added December 10, 2013
Selection of the ideal antiseptic or antimicrobial treatment for contaminated wounds remains a controversial decision. Clinical decisions are often made on the basis of in vitro studies and personal preference. Although topical solutions are widely used, their comparative in vivo effects on wound healing are largely unreported.A porcine wound model was used to compare five commonly used topical agents-5% mafenide acetate (Sulfamylon solution), 10% povidone with 1% free iodine (Betadine), 0.25% sodium hypochlorite ("half-strength" Dakin), 3% hydrogen peroxide, and 0.25% acetic acid-with a control group. Reepithelialization, angiogenesis, neodermal regeneration, fibroblast proliferation, collagen production, and bacterial colony counts were analyzed at 4 and 7 days after wounding (n = 4). Reepithelialization was not significantly influenced among the various treatment modalities tested. Sulfamylon and Dakin solutions significantly increased neodermal thickness (p < 0.05), whereas hydrogen peroxide and acetic acid significantly inhibited neodermal formation (p < 0.001). All treatments except hydrogen peroxide significantly increased fibroblast proliferation. Sulfamylon and Betadine significantly enhanced angiogenesis (p < 0.05). Sulfamylon proved most effective in maintaining an aseptic environment while concomitantly increasing angiogenesis, fibroblast proliferation, and dermal thickness compared with control. These data show that selection of a particular topical treatment can affect various aspects of wound repair in an animal model. These results suggest that the selection of topical treatments in the clinical setting should be carefully tailored to match unique wound situations and therapeutic endpoints.
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8 MeSH Terms