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PubMed1981

[Pharmacokinetics and biotransformation of the antimycotic drug ciclopiroxolamine in animals and man after topical and systemic administration].

1. Following the dermal application of the carbon-14 labelled broad spectrum antimycotic 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt (ciclopiroxolamine, Hoe 296, Batrafen) in the form of a 1% aqueous cream to healthy human dorsal skin (penetration time: 6 h; occlusive dressing for 5 h), percutaneous absorption accounted on average for 1.3% of the dose applied. Excretion occurred via the kidney, with biological half-lives of 1.7 h. As can be seen from penetration studies of cadaverous skin, the horny layer contained the highest concentrations, with values of 2300-4500 microgram/cm3. The levels determined in the corium were still above the minimum inhibitory concentrations. These concentrations were already obtained at the first test stage (1.5 h after application) and did not change virtually at all over the longer penetration period. According to studies using histoautoradiography, ciclopirox can penetrate the skin via the epidermis and the hair follicles. When ciclopirox-14C-olamine aqueous cream was spread on the surface of fingernails, the radioactive-labelled compound penetrated right through the nail. The percutaneous absorption in dogs was higher, at 5-15% of the dose, than it was in humans. 2. After vaginal application (1 mg/kg) of ciclopirox-14C-olamine in the form of a 1% aqueous cream to bitches, between 42 and 97% of the dose (depending on the animal) was recovered in the urine and faeces, the remainder having penetrated into the tampon used to close the vagina. 3. Ciclopirox is excreted by dogs and man in the urine, primarily as a glucuronide. In humans another glucuronide with properties similar to those of the original substance was detected. Two conjugated, relatively non-polar metabolites were also present in small amounts. The metabolite patterns after oral and dermal application were similar. The binding of ciclopirox to serum proteins in humans was 96 +/- 2% in a concentration range of 0.01-11.0 microgram/ml. 4. Placental transfer was low in the rats studied. Though there was good absorption by the mother animal, the radioactivity in the foetal tissues was always lower than that of the maternal blood.

Administration, Oral↗

PubMed1980

[Topically applied thiabendazole in the treatment of creeping eruption (cutaneous helminthiasis) (author's transl)].

Two patients with creeping eruption (cutaneous helminthiasis) on the feet contracted during a vacation in Ceylon were treated successfully by topical application of thiabendazole 50% in a paste destined for oral use in veterinary medicine. The preparation was applied once daily under occlusive dressings. There was no skin irritation. Prompt healing occurred after 3 and 6 days respectively. Because systemic thiabendazole therapy is frequently associated with toxic side effects, topical application seems to be the treatment of choice for creeping eruption caused by nematodes.

Administration, Topical↗

PubMed1995

Growth factors in porcine full and partial thickness burn repair. Differing targets and effects of keratinocyte growth factor, platelet-derived growth factor-BB, epidermal growth factor, and neu differentiation factor.

The topical application of recombinant growth factors such as epidermal growth factor, platelet-derived growth factor-BB homodimer (rPDGF-BB), keratinocyte growth factor (rKGF), and neu differentiation factor has resulted in significant acceleration of healing in several animal models of wound repair. In this study, we established highly reproducible and quantifiable full and deep partial thickness porcine burn models in which burns were escharectomized 4 or 5 days postburn and covered with an occlusive dressing to replicate the standard treatment in human burn patients. We then applied these growth factors to assess their efficacy on several parameters of wound repair: extracellular matrix and granulation tissue production, percent reepithelialization, and new epithelial area. In full thickness burns, only rPDGF-BB and the combination of rPDGF-BB and rKGF induced significant changes in burn repair. rPDGF-BB induced marked extracellular matrix and granulation tissue production (P = 0.013) such that the burn defect was filled within several days of escharectomy, but had no effect on new epithelial area or reepithelialization. The combination of rPDGF-BB and rKGF in full thickness burns resulted in a highly significant increase in extracellular matrix and granulation tissue area (P = 0.0009) and a significant increase in new epithelial area (P = 0.007), but had no effect on reepithelialization. In deep partial thickness burns, rKGF induced the most consistent changes. Daily application of rKGF induced a highly significant increase in new epithelial area (P < 0.0001) but induced only a modest increase in reepithelialization (83.7% rKGF-treated versus 70.2% control; P = 0.016) 12 days postburn. rKGF also doubled the number of fully reepithelialized burns (P = 0.02) at 13 days postburn, at least partially because of marked stimulation of both epidermal and follicular proliferation as assessed by proliferating cell nuclear antigen expression. In situ hybridization for KGFR in porcine burns revealed strong expression of KGFR on hair follicles and basal epidermis, confirming direct rKGF action on follicular as well as epidermal keratinocytes. Although the epithelial proliferation induced by rKGF resulted in marked neoepidermal psoriasiform hyperplasia with exaggerated rete ridges and neoepidermal and follicular maturation as assessed by expression of cytokeratin 10, a marker of keratinocyte terminal differentiation was not delayed and appeared to be accelerated in some rKGF-treated burns. Recombinant epidermal growth factor induced a trend toward increased new epithelial area in deep partial thickness burns, but had no effect on reepithelialization. The recombinant neu differentiation factor-alpha 2 isoform had no significant biological effects in either full or deep partial thickness burns.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Topical↗

PubMed1994

Dermal absorption of fluprednidene-21-acetate and miconazole from a new topical preparation in pigs.

The dermal absorption of fluprednidene-21-acetate (CAS 1255-35-2) and miconazole nitrate (CAS 22832-87-7) of a new combination cream (Decoderm tri) was studied in pigs after application of 0.5 g cream/kg body weight under occlusive dressing for 5 h. 3H-labelled fluprednidene-21-acetate and 14C-labelled miconazole nitrate were introduced into the base cream as single components or in combination. The three resulting creams were tested in groups of 3 pigs each. To obtain a basis for the assessment of the data after dermal application the two labelled drugs were also examined after intravenous injection. Based on the comparison of the AUC of the radioactive labels an absorption of 4.4% for fluprednidene-21-acetate was calculated when administered alone and 2.4% when administered in the combination cream. For miconazole a smaller absorbed fraction of the dermal dose of 0.5 and 0.8%, resp., was found. Since the differences between single and combined administration were not significant, it follows that there is no relevant reciprocal influence of the two compounds on their dermal absorption.

Administration, Topical↗

PubMed1976

Psoriasis: topical corticosteroid therapy.

Fifty-nine patients with bilateral psoriatic lesions were subjects in a double-blind paired comparison of halcinonide cream and fluocinonide cream. They applied the corticosteroid creams twice a day for 14 days without occlusive dressings. Objective and subjective assessment of response to therapy was made four or five days, one week, and two weeks after starting treatment. The results were analyzed by statistical methods. At the second visit (day 4 or 5), there was little difference between the two compounds, but at visits three and four, reduction of inflammation was significantly better with halcinonide than with fluocinonide.

Adult↗

PubMed1993

[Squamous syringometaplasia: an original manifestation of pathomimesis].

INTRODUCTION: Epidermoid syringometaplasia consists in rare changes of the eccrine sweat glands, which show keratinization of their ductal part. Many conditions are associated with epidermoid syringometaplasia: chronic ulcers, scars, keratoacanthoma and various drugs or toxic agents, suggesting a toxic effect of drugs or an inflammatory mechanism. OBSERVATION: A 22-year-old woman presented with large painless ulcero-vegetating lesions of the forearm; the X-ray examination showed an major emphysema. She also had multiple scars on her trunk and limbs. The curious features of the lesions and the psychiatric troubles suggested the diagnosis of dermatitis artefacta. Histopathological examination showed a pseudocarcinomatous epidermal hyperplasia; in the deep dermis the eccrine ducts were connected to the epidermal cell masses or seemed to be included into the proliferation. Keratinization was noted within the keratinocytes surrounding the duct lumen. A dense inflammatory cell infiltrate was observed, containing many macrophages with a foamy cytoplasm, probably resulting from the injection of a foreign substance. All lesions healed within a few days using an occlusive dressing. COMMENTS: In this patient, the voluntary injection of an unknown substance probably induced these metaplastic changes of the sweat ducts, which are probably related to a toxic mechanism. Epidermoid syringometaplasia has never been described after cutaneous injections.

Adult↗

PubMed1993

[Comparison of irradiated porcine skin with exposure or occlusive method in the care of second degree burn wounds].

This article compared irradiated porcine skin with exposure and occlusive method in the care of second degree burn wounds. In 30 patients in whom irradiated porcine skin (IPS) was used, no wound infection occurred. The rate of wound infection, in patients on whom herb medicine and exposure method were used, was 19% (7/37), and that of occlusive dressing plus drug group was 22% (2/9). The rate of wound infection of IPS was significantly lower than the other two groups (P < 0.05). The time of wound healing in IPS group was 13.5 + 5.03 days; it was significantly shorter than the other two groups.

Adolescent↗

PubMedDate not supplied

Lidocaine 2.5%/prilocaine 2.5% EMLA cream.

EMLA cream is a topical emulsion composed of prilocaine and lidocaine, produced complete anesthesia of intact skin following application. For the optimum effect, EMLA cream must be applied and covered with an occlusive dressing for 60 minutes prior to the procedure. This limits its use in emergency situations. However, in most situations where procedures are anticipated, EMLA can be applied in advance, including outpatient surgery. Furthermore, if the procedure is a venipuncture, multiple sites should be prepared in case one's initial attempt is unsuccessful. EMLA has been used in children of all ages and provides significant pain relief for venipunctures and lumbar punctures; it is being investigated in children for intramuscular injections and circumcision.

Absorption↗

PubMed1993

An appraisal of povidone-iodine and wound healing.

Infection is one of the most frequent complications of wound healing despite the use of antibiotics and modern sterile technique; it accounts for considerable patient morbidity, discomfort, and prolonged hospitalization, and it must be avoided to permit proper healing. For this purpose, topical antiseptics have been employed for several years. Among these povidone-iodine formulations (polyvinylpyrrolidone iodine; PVP-I; e.g., Betadine preparations), which consist of a water-soluble complex of elemental iodine and a synthetic polymer, have a broad antimicrobial spectrum, and have not been reported to develop bacterial resistance. Because some reports have suggested that PVP-I may interfere with wound healing, a critical review of studies concerning PVP-I and wound healing was undertaken, with emphasis placed on in vivo models that replicate, as closely as possible, human wound healing. Four forms of PVP-I were evaluated: PVP-I solution, PVP-I skin cleanser/surgical scrub, PVP-I ointment, and PVP-I cream. PVP-I solutions had virtually no deleterious effect on wound healing: application of 10% PVP-I solution to rat, guinea pig, rabbit, or pig wounds did not reduce wound tensile strength or delay re-epithelialization. In three human studies, no significant difference in healing was observed for 1%, 5% or 10% PVP-I solution except for a slight delay during the first 24 hours after the application of 5% PVP-I solution in one study; healing was normal by 72 hours. PVP-I skin cleansers/surgical scrubs contain ammonium nonoxynol-4-sulphate and lauramide DEA which, like all detergents, can cause tissue damage and delay healing. This was substantiated by a guinea pig study in which the detergent component but no the antiseptic produced these effects. In human trials, no damage occurred if cleansing of the wound with PVP-I skin cleansers/surgical scrubs was followed by saline irrigation. These results are consistent with recommendations for promptly rinsing the wound with water to remove the detergent if detergent-containing PVP-I preparations are used for wound care. PVP-I ointment (10%) delayed wound closure inn rats during the fourth through tenth days post-treatment; however, during the next two weeks, healing was accelerated, and by day 24, healing was equal to the controls. No delays occurred when pigs or rabbits were tested. In human wounds, no delays occurred in healing, even when gel-type occlusive dressings were added to the wounds; in fact, bandage-wearing time was shortened in those patients treated with PVP-I ointment. PVP-I cream (5%) was also studied in humans; the cream formulation appeared to decrease healing time. Based on these studies, it can be concluded that povidone-iodine preparations do not have a deleterious effect on wound healing.

Animals↗

PubMed1993

Effect of a topical anesthetic cream (EMLA) in reducing pain caused by infiltration of local anesthetic in eyelid surgery.

EMLA (eutectic mixture of local anesthetics) cream is a topical formulation of a mixture of lidocaine and prilocaine. It has been used to achieve local analgesia after application under an occlusive dressing. We carried out a double-blind randomized controlled clinical trial to assess the effect of 5% EMLA (25 mg/mL of lidocaine and of prilocaine) in reducing the pain caused by infiltration of local anesthetic in eyelid surgery. Pain was assessed by means of a modified visual analogue scale ranging from 0 (no pain) to 10 (excruciating pain) in 25 consecutive patients (average age 65 years) undergoing bilateral eyelid surgery. Clinical significance was defined as a difference in pain scores of 3 or more between EMLA and placebo. The mean pain scores for EMLA and placebo were 3.1 and 4.0 respectively, a nonsignificant difference. The EMLA preparation was found not to be clinically effective in reducing pain caused by infiltration of local anesthetic in eyelid surgery.

Aged↗

PubMed1993

Pressure ulcers: updated guidelines for treatment and prevention.

Pressure ulcers are prevalent and associated with high rates of morbidity and mortality in older patients. Four primary forces--pressure, shearing, friction, and moisture--contribute to their formation. A number of factors place patients at risk, including immobility, age-related skin changes, malnutrition, and cognitive impairment. Turning schedules, special bed surfaces, and other preventive measures have been shown to significantly reduce the effects of these factors. When an ulcer does form, treatment is based on the degree of tissue damage and includes pressure-reducing devices, systemic measures, and local care with debridement, occlusive dressings, and sometimes surgery.

Aged↗

PubMedDate not supplied

Characteristics and prevention of wound infection.

This article provides an overview of bacterial wound infection. It examines definitions of infection, types and concentrations of bacteria in wounds at different stages of healing, and the significance of osteomyelitis and sepsis in deep, necrotic ulcers. It also describes the culturing of wounds and examines the use of topical antimicrobials, debridement, irrigation, and occlusive dressings. Factors in surgical wound infection and infection control are examined. Finally, systemic factors are summarized.

Bacterial Infections↗

PubMed1977

[Clinico-experimental testing for anti-inflammatory activity of external corticosteroids].

Clinical trials of the anti-inflammatory activity of corticosteroids for external use The influence on skin temperature of 4 corticoid-containing formulations and 3 steroid-free bases was tested in 9 subjects in whom no pathological skin changes were present but who were known to be sensitive to metal ions (chromium and nickel). The effect of the preparations on the healthy skin (vasoconstrictive effect) after a duration of action of 2 and 6 h was compared with the effect on skin sites treated subsequently with the contact allergens for a period of 24 h. In the procedure used the trial preparations were allowed to act for 2 and 6 h under occlusive dressing, or for 4 and 8 h, the dressing being removed for 2 h in each case. The allergization produced an increase in temperature at the skin surface which was influenced in various ways by the trial preparations. Whereas no statistically significant differences in the effect of the individual steroid topicals were found the healthy skin, in the evaluatin of the overall anti-inflammatory effect on the pathological skin processes, some distinct differences in effect were found. On comparing the results the following lowing order was obtained for the overall anti-inflammatory effect: 1. Fluprednylidene acetate 0.1% score 4.5, 2. Difluocortolone-valerate 0.1% score 8.5, 3. Fluocortolone trimethylacetate 0.25% + fluocortolone caproate 0.25% score 12, 4. Desoxymethasone 0.1% score 15, The steroid-free bases tested simultaneously did not exhibit clear effects on the temperature in the normal or inflamed skin. The results of the test procedure described are reproducible and can be evaluated by statistical method; the method thus seems appropriate for comparative studies of steroid-containing topicals. The special value in the procedure is the possibility of testing the effect of the preparations directly in a standardised inflammation model which is directly related to use in patients with inflammatory skin diseases, and of establishing in this way in which preparations the anti-inflammatory effect obtained exceeds the general effect common to all steroids.

Administration, Topical↗

PubMed1996

Ocular toxicity following topical application of anesthetic cream to the eyelid skin.

BACKGROUND AND OBJECTIVE: The use of topical anesthetic cream in the periorbital region may be of clinical value. The potential for toxic effects from such use has not been studied in a controlled manner. This study was performed to evaluate the potential ocular toxicity of anesthetic cream topically applied to the eyelid in an animal model. MATERIALS AND METHODS: Ten rabbits underwent periorbital eutectic mixture of local anesthetics (EMLA) (2.5 percent lidocaine and 2.5 percent prilocaine) application and were observed for evidence of gross or microscopic ocular toxicity. Baseline external and anterior segment examinations were performed, including biomicroscopy and fluorescein staining, after which a standard quantity of EMLA cream (0.75 g) was applied along the upper eyelid and covered with an occlusive dressing. After 1 hour of treatment, the eyelid and anterior segment were examined for evidence of adverse reaction. The eyelids were excised and examined histopathologically. RESULTS: No significant adverse effects were noted on external lid and anterior segment examination. The histopathologic findings were within normal limits. CONCLUSIONS: This study suggests that external application of EMLA cream to the eyelid does not induce local toxicity in the rabbit model. The external application of EMLA cream may be safe in the periorbital region.

Administration, Topical↗

PubMed1996

Comparison of maxillectomy patients with immediate versus delayed obturator prosthesis placement.

OBJECTIVE: To compare maxillectomy patients with immediate versus delayed placement of an obturator prosthesis in terms of patient outcomes. DESIGN: Retrospective review. OUTCOME MEASURES: The outcomes of 23 maxillectomy patients seen between 1975 and 1993 at St. Joseph's Health Centre in London, Ontario, were analyzed. METHODS: For 17 patients, a prosthesis was placed immediately as part of the operative procedure, and for 6 patients, an occlusive dressing only was placed. RESULTS: In all parameters studied (length of stay, i.v. requirements, swallowing, clear fluid diet and ambulation), the prosthesis group progressed more quickly and had a more rapid return to normal function. CONCLUSION: This study demonstrates the benefits of immediate prostheses for maxillectomy patients and justifies their continued use.

Adult↗

PubMed1996

[Percutaneous drainage of septic hip arthritis in children].

INTRODUCTION: Hip arthritis is a therapeutic emergency which requires sure diagnosis and pus evacuation. Two methods are presently in use: isolated or oriterative punction and arthrotomy. TECHNIQUE: A Pleurocath is introduced under general anesthesia and under fluoroscopic control by an obturator approach. It contains a perforated trocart which allows a flexible catheter, perforated over the last few centimeters to be inserted. The introduction point must be as far posterior as possible, in the plane of the anterior border of the femoral neck to promote declivious downward. It allows for pus evacuation, confirmation of the diagnosis and bacteriological samples to be taken. The lavage is done using ionized polyvidone dilution in physiological saline solution. The catheter is inserted in the center of the trocart and pushed intra-articularly under fluoroscopic control. The trocart is pulled out. The catheter is fixed on the skin using non resorbable thread. An occlusive dressing is made. A three way cock is installed for aspiration and lavage. Drainage is declivious. MATERIAL AND METHODS: This percutaneous drainage technique was used in three cases of septic hip arthritis in children. Treatment associated drainage, immobilization by traction and double or triple intravenous antibiotics. The hips healed without any detrimental effects. DISCUSSION: The punction had both a diagnosis and a therapeutic objective, as it allows pus evacuation in the same time. It can be repeated according to the patient's progress. Most authors prefer arthrotomy with careful lavage and good drainage. We suggest an intermediate technique which includes punction and allows clinical and bacteriological diagnosis, joint lavage and drainage. Using permanent drainage, the hip joint is protected from high pressure. It makes repeated lavage possible when the pus is thick, and avoids the drain from becoming plugged. CONCLUSION: This approach enables the pus to be evacuated, bacteriological samples to be taken, lavage and drainage. The drainage must be left until apyrexia and normal biological inflammation criteria are obtained.

Arthritis, Infectious↗

PubMed1997

Studies on the metabolism and disposition of the new retinoid 4-[(5,6,7,8-tetrahydro-5,5,8,8-tetramethyl-2-naphthyl)carbamoyl] benzoic acid. 1st communication: absorption, distribution, metabolism and excretion after topical application and subcutaneous administration in rats.

Administration, Topical↗

PubMed1997

Studies on the metabolism and disposition of the new retinoid 4-[(5,6,7,8-tetrahydro-5,5,8,8-tetramethyl-2-naphthyl)carbamoyl] benzoic acid. 4th communication: absorption, metabolism, excretion and plasma protein binding in various animals and man.

4-[(5,6,7,8-Tetrahydro-5,5,8,8-tetramethyl-2-naphthyl)carbamoyl]benzoic acid (CAS 94497-51-5, Am-80) is a new synthetic retinoid which has been shown to have a potent topical antipsoriatic activity. Pharmaco-kinetic profiles of Am-80 were studied in dogs, mice and rabbits after percutaneous or subcutaneous administration of 14C-Am-80. Plasma protein binding of 14C-Am-80 was also studied in rats, dogs and humans. After topical application of 14C-labeled Am-80 by occlusive dressing technique at a dose of 1 mg 14C-Am-80/1,000 mg ointment/kg, the blood and plasma levels of radioactivity were below the detection limit in normal-skin dogs. In normal skin mice and rabbits, the plasma radioactivity peaked at 8 h (40.8 ng eq./ml) and at 12 h (34.0 ng eq./ml) after application, respectively. Percutaneous absorption of 14C-Am-80 was less than 2% of the dose for dogs, 34% for mice and 23% for rabbits. After subcutaneous administration at a dose of 1 mg/kg to mice, dogs and rabbits, plasma levels of radioactivity peaked at 1, 4 and 4 h after dosing with a concentration of 614.0, 902.9 and 757.7 ng eq./ml and then it declined with half-lives of 2.4, 7.2 and 4.1 h, respectively. Urinary and fecal excretion of radioactivity after subcutaneous administration at a dose of 1 mg/kg was 3.5 and 94.7% of the dose in dogs, 27.0 and 73.2% in mice and 43.5 and 45.6% in rabbits. A possible gastrointestinal secretion, which might lead to excretion into feces, was suggested from the results with bile-duct-cannulated dogs. Unchanged Am-80 was present in high amounts in the plasma and bile or feces of all animal species tested except in rat bile, in which Am-80 was predominantly detected in the form of its taurine conjugate (M-6). Hydroxylation of Am-80 to yield 7-hydroxy-Am-80 (M-4) and 6-hydroxy-Am-80 (M-3), which lead to the formation of 6-oxo-Am-80 (M-5), were commonly observed in all animal species. Taurine conjugation reaction of unchanged Am-80 and hydroxy-Am-80 (to form M-6 and both M-1 and M-2, respectively) was distinct in rats and dogs, but, hardly detected in mice and rabbits. The presence of tetrahydro-tetramethyl-naphtylamine (TTNA) was most marked in mice, followed by rabbits and rats, but it was almost absent in dogs. HPLC-RIA analysis of human samples obtained from the phase II and phase III clinical trials of Am-80 ointment suggested that fecal excretion was the major elimination route, and that hydroxylation and taurine conjugation reaction of unchanged and hydroxy-Am-80 also occurred. Unchanged Am-80 was predominant in human plasma as compared with metabolites M-1 to M-6. In vitro binding of 14C-Am-80 to the plasma protein was found to be more than 99% in rats, dogs and humans. In vivo plasma protein binding of 14C-Am-80 and/or its radioactive metabolites was also found to be more than 98% in rats and dogs after subcutaneous administration of 14C-Am-80. In both dogs and humans, in vitro. 14C-Am-80 appeared to be bound predominantly to serum albumin. The binding of 14C-Am-80 to human serum albumin was scarcely affected in the presence of diazepam, digitoxin or warfarin, indicating that there are no specific binding sites for Am-80 on serum albumin.

Administration, Topical↗