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1.
Article in English | MEDLINE | ID: mdl-36905622

ABSTRACT

BACKGROUND: The purpose of this study was to evaluate the effectiveness of tap water iontophoresis as a treatment for plantar hyperhidrosis. METHODS: Thirty participants living with idiopathic plantar hyperhidrosis and consented to undergo treatment using iontophoresis were recruited. The Hyperhidrosis Disease Severity Score was used to evaluate the severity of the condition before and after treatment. RESULTS: Tap water iontophoresis was found to be effective in the treatment of plantar hyperhidrosis in the study group (P = .005). CONCLUSIONS: Treatment with iontophoresis led to the reduction of disease severity and improvement of quality of life, and it is a safe, easy-to-use method with minimal side effects. This technique should be considered before the use of systemic or aggressive surgical interventions, which could have potentially more severe side effects.


Subject(s)
Hyperhidrosis , Iontophoresis , Humans , Iontophoresis/adverse effects , Iontophoresis/methods , Quality of Life , Water
2.
Article in English | MEDLINE | ID: mdl-35886341

ABSTRACT

INTRODUCTION: Osteoarthritis (OA) is one of the most common causes of pain in the musculoskeletal system leading to disability. The basic principle of the therapy is the simultaneous use of pharmacological and non-pharmacological treatments. The aim of this study was to evaluate the effectiveness of galvanic and iontophoresis treatments with Perskindol Active Classic Gel (Perskindol) in patients with OA of the knee joints. Moreover, a comparative evaluation of the effectiveness of the application was performed depending on the selection of the active electrode. MATERIAL AND METHODS: The study included 100 patients with gonarthrosis, treated at the Rehabilitation Clinic of the Bialystok University Hospital. Three groups were randomly selected: in group I (n = 33), anodic galvanic treatment was applied, group II (n = 33) received iontophoresis with Perskindol gel from the negative pole ("-" iontophoresis), and group III (n = 34) received iontophoresis with Perskindol gel from the positive pole ("+" iontophoresis). The VAS, the Laitinen questionnaire, the Lequesne Index, the Lysholm questionnaire, and the SF-36v2 health survey were used for the clinical evaluation of the patients. RESULTS: In the group of patients who underwent iontophoresis with the use of Perskindol gel introduced from the positive pole, a statistically significant improvement was shown in all the assessed parameters in comparison to the patients who underwent anodic galvanic treatment. CONCLUSIONS: The most favorable effect of iontophoresis was observed in the case of iontophoresis with Perskindol gel introduced from the positive pole.


Subject(s)
Osteoarthritis, Knee , Humans , Iontophoresis/adverse effects , Knee Joint , Osteoarthritis, Knee/complications , Osteoarthritis, Knee/drug therapy , Pain/etiology , Treatment Outcome
3.
J Cosmet Dermatol ; 21(5): 2162-2168, 2022 May.
Article in English | MEDLINE | ID: mdl-34982502

ABSTRACT

BACKGROUND: Tap water iontophoresis (TWI) is an effective treatment option for palmoplantar hyperhidrosis (HH). However, the optimal number and frequency of TWI sessions to control profuse sweating are unclear. OBJECTIVE: To compare the efficacy of 10 and 20 sessions of TWI in patients with palmoplantar HH and determine the adequate number of sessions to achieve a favorable clinical response. METHODS: Eighty patients treated with TWI for palmoplantar HH were included. The alteration in sweating intensity considering the mean value of gravimetric measurement and mean visual analog scale (VAS) scores after the 10th and 20th session of TWI were calculated. The difference between performing 10 and 20 sessions of TWI in providing improvement of HH was analyzed. We also conducted a telephone-based inquiry to determine the patients' outcome. RESULTS: The reduction in sweating intensity was significant both after the 10th (p < 0.001) and 20th (p < 0.001) sessions when compared with the basal level considering gravimetry and VAS. When the mean sweating intensity after the 10th and 20th sessions were compared, no difference was observed gravimetrically (p = 0.03); the difference between the mean score of VAS after the 10th and 20th sessions (p < 0.001) was significant. Eleven and nine patients not considering a maintenance or an alternative treatment had lower and same sweating intensity as compared with the baseline, respectively. CONCLUSION: Ten TWI sessions within two weeks for managing palmoplantar HH are adequate to achieve a clinical response. However, the patients are more satisfied when they receive 20 sessions instead of 10 sessions of TWI.


Subject(s)
Hyperhidrosis , Iontophoresis , Humans , Hyperhidrosis/drug therapy , Hyperhidrosis/therapy , Iontophoresis/adverse effects , Sweating , Treatment Outcome , Water
4.
Adv Drug Deliv Rev ; 153: 2-17, 2020 01 01.
Article in English | MEDLINE | ID: mdl-32339593

ABSTRACT

This review analyses physical drug delivery enhancement technologies with a focus on improving UV damaged skin, actinic keratoses and non-melanoma skin cancer treatment. In recent years, physical drug delivery enhancement has been shown to enhance cosmeceutical and skin cancer treatment efficacy, but there are pros and cons to each approach which we discuss in detail. Mechanisms of action, clinical efficacy, experimental design, outcomes in academic publications, clinical trial reports and patents are explored to evaluate each technology with a critical, translation focused lens. We conclude that the commercial success of cosmeceutical applications, e.g. microneedles, will drive further innovation in this arena that will impact how actinic keratoses and non-melanoma skin cancers are clinically managed.


Subject(s)
Dermatologic Agents/therapeutic use , Drug Delivery Systems/methods , Keratosis, Actinic/drug therapy , Skin Aging/drug effects , Skin Neoplasms/drug therapy , Administration, Cutaneous , Clinical Trials as Topic , Cosmetic Techniques , Dermatologic Agents/administration & dosage , Dermatologic Agents/adverse effects , Dermatologic Agents/pharmacology , Humans , Iontophoresis/adverse effects , Iontophoresis/methods , Laser Therapy/adverse effects , Laser Therapy/methods , Microinjections/adverse effects , Microinjections/methods , Skin/physiopathology , Skin Aging/physiology , Skin Neoplasms/physiopathology , Ultrasonography/adverse effects , Ultrasonography/methods , Ultraviolet Rays/adverse effects
5.
J Clin Pharmacol ; 60(6): 758-767, 2020 06.
Article in English | MEDLINE | ID: mdl-32080862

ABSTRACT

Digital skin ulcers are a severe complication of systemic sclerosis. The first-line treatment is intravenous iloprost, but it induces dose-limiting adverse effects. Local administration of treprostinil through skin iontophoresis may be a safe alternative. We conducted a 2-stage, randomized, placebo-controlled single-ascending-dose study in healthy volunteers and patients with systemic sclerosis-related digital ulcer. We further explored the effect of the procedure on skin blood flux. In a first group of healthy subjects, treprostinil and placebo iontophoresis were performed at 3 locations (ie, 6 skin sites): the sole of the foot, the leg, and the fingers. We used a 1-mg/mL hydrogel of treprostinil. We then randomly treated systemic sclerosis-related digital ulcers in a 3:1 ratio of treprostinil or placebo. We used concentrations from 0.1 to 1 mg/mL. All adverse events were recorded and rated according to the Common Terminology Criteria for Adverse Events (CTCAE), whereas skin microvascular blood flux was recorded with laser speckle contrast imaging. Among the 12 healthy volunteers, we observed 60 local adverse effects: burns, skin pain, erythema, and pruritus, graded 1 or 2 on the 5-point CTCAE scale. Treprostinil iontophoresis significantly increased skin blood flux on the leg (AUC0-4 h at 88 460% ± 6436% versus 12 730% ± 3397% baseline flux.min respectively; P < .001) and on the sole of the foot (AUC0-3 h at 20 124% ± 6119% versus 3142% ± 3036% baseline flux.min, respectively; P = .018) with a trend on the finger. Among 5 patients with systemic sclerosis-related digital ulcer, 2 resolutive local adverse effects were reported. Iontophoresis of treprostinil hydrogel was safe in systemic sclerosis patients with digital ulcer.


Subject(s)
Epoprostenol/analogs & derivatives , Scleroderma, Systemic/drug therapy , Skin Ulcer/drug therapy , Administration, Cutaneous , Adult , Blood Circulation/drug effects , Double-Blind Method , Epoprostenol/administration & dosage , Epoprostenol/adverse effects , Female , Fingers/blood supply , Foot/blood supply , Healthy Volunteers , Humans , Hydrogels/adverse effects , Iontophoresis/adverse effects , Male , Middle Aged , Scleroderma, Systemic/etiology , Skin/blood supply , Skin/drug effects , Skin Temperature/drug effects , Skin Ulcer/complications , Toes/blood supply , Young Adult
6.
BMJ Case Rep ; 12(6)2019 Jun 08.
Article in English | MEDLINE | ID: mdl-31177194

ABSTRACT

An 8-month-old child presented after an emergency referral from a paediatric clinic. She had sustained a small burn injury to the left volar wrist during the sweat test for cystic fibrosis. The injury was managed conservatively. There is limited literature on burn injuries sustained during the sweat test, despite it being a known risk and the incidence is reported as very small. We wonder if such events are not being reported because the injury caused is usually minor and so may be more prevalent than previously considered.


Subject(s)
Cystic Fibrosis/diagnosis , Iontophoresis/adverse effects , Skin/injuries , Sweat/metabolism , Burns/etiology , Burns/pathology , Conservative Treatment , Female , Humans , Infant
7.
Acta Derm Venereol ; 98(10): 943-950, 2018 Nov 05.
Article in English | MEDLINE | ID: mdl-29856465

ABSTRACT

Nocebo effects, i.e. reduced treatment effects due to patients' negative expectations, play a role in itch. Recent studies have shown that nocebo effects can be induced experimentally on itch and also be minimized and even turned into the opposite direction, i.e. placebo effects. It is not known whether these effects generalize to itch-associated scratching behaviour. The aim of this study was to determine whether induction and reversal of nocebo effects on itch evoked by electrical and histamine stimuli generalized to scratching. Ninety-seven healthy participants were included in the study. The manipulation was successful, as during the nocebo learning phase, increased scratching responses were found for higher intensity compared with lower intensity itch stimuli. During the testing phase of induction or reversal of the nocebo effects, however, no significant nocebo effects or reversed nocebo effects, were found in scratching. Thus, no straightforward generalization of nocebo effects from itch to scratching was found in this laboratory setting. Further investigation into possible generalization is needed in different settings and in patients with chronic itch.


Subject(s)
Behavior , Nocebo Effect , Pruritus/psychology , Adolescent , Conditioning, Psychological , Cues , Electric Stimulation/adverse effects , Female , Healthy Volunteers , Histamine/adverse effects , Humans , Iontophoresis/adverse effects , Male , Placebo Effect , Pruritus/etiology , Young Adult
8.
Br J Dermatol ; 179(3): 599-608, 2018 09.
Article in English | MEDLINE | ID: mdl-29573391

ABSTRACT

BACKGROUND: Hyperhidrosis is uncontrollable excessive sweating, which occurs at rest, regardless of temperature. The symptoms of hyperhidrosis can significantly affect quality of life. OBJECTIVES: To undertake a systematic review of the clinical effectiveness and safety of treatments available in secondary care for the management of primary hyperhidrosis. METHODS: Fifteen databases (including trial registers) were searched to July 2016 to identify studies of secondary-care treatments for primary hyperhidrosis. For each intervention randomized controlled trials (RCTs) were included where available; where RCT evidence was lacking, nonrandomized trials or large prospective case series were included. Outcomes of interest included disease severity, sweat rate, quality of life, patient satisfaction and adverse events. Trial quality was assessed using a modified version of the Cochrane Risk of Bias tool. Results were pooled in pairwise meta-analyses where appropriate, otherwise a narrative synthesis was presented. RESULTS: Fifty studies were included in the review: 32 RCTs, 17 nonrandomized trials and one case series. The studies varied in terms of population, intervention and methods of outcome assessment. Most studies were small, at high risk of bias and poorly reported. The interventions assessed were iontophoresis, botulinum toxin (BTX) injections, anticholinergic medications, curettage and newer energy-based technologies that damage the sweat gland. CONCLUSIONS: The evidence for the effectiveness and safety of treatments for primary hyperhidrosis is limited overall, and few firm conclusions can be drawn. However, there is moderate-quality evidence to support the use of BTX for axillary hyperhidrosis. A trial comparing BTX with iontophoresis for palmar hyperhidrosis is warranted.


Subject(s)
Hyperhidrosis/therapy , Patient Satisfaction , Secondary Care/methods , Botulinum Toxins, Type A/administration & dosage , Botulinum Toxins, Type A/adverse effects , Cholinergic Antagonists/administration & dosage , Cholinergic Antagonists/adverse effects , Curettage/adverse effects , Curettage/methods , Humans , Hyperhidrosis/diagnosis , Hyperhidrosis/pathology , Iontophoresis/adverse effects , Iontophoresis/methods , Low-Level Light Therapy/adverse effects , Low-Level Light Therapy/methods , Radiofrequency Ablation/adverse effects , Radiofrequency Ablation/methods , Randomized Controlled Trials as Topic , Severity of Illness Index , Sweat Glands/pathology , Sweat Glands/radiation effects , Treatment Outcome
11.
J Dermatol ; 44(4): 401-405, 2017 Apr.
Article in English | MEDLINE | ID: mdl-27743393

ABSTRACT

The standard management of acne vulgaris in Japan includes a combination of topical treatment with benzoyl peroxide (BPO) and BPO/clindamycin (CLDM), topical adapalene and systemic antimicrobials. However, the treatment of therapy-resistant complications such as postinflammatory hyperpigmentation (PIH), erosions with inflamed red papules and atrophic scars has not been established. We performed chemical peeling with glycolic acid and iontophoresis with ascorbyl 2-phosphate 6-palmitate and DL-α-tocopherol phosphate for the treatment of PIH, erosions with inflamed red papules and non-inflamed atrophic scars in 31 patients with acne vulgaris (mild to severe severity), and evaluated the efficacy and safety of these interventions. In most of cases, there was remarkable improvement in PIH and erosions with inflamed red papules after treatment. There was also some improvement in non-inflamed atrophic scars without erythema. Mild redness and irritation was observed in four cases as adverse reactions. Early initial treatment of PIH and erosions with red papules by chemical peeling and iontophoresis is an effective and safe method to prevent the formation of atrophic scars in patients with acne vulgaris.


Subject(s)
Acne Vulgaris/complications , Acne Vulgaris/therapy , Chemexfoliation/adverse effects , Cicatrix/therapy , Erythema/therapy , Hyperpigmentation/therapy , Iontophoresis/adverse effects , Adapalene/therapeutic use , Adolescent , Adult , Anti-Infective Agents/therapeutic use , Ascorbic Acid/administration & dosage , Ascorbic Acid/adverse effects , Ascorbic Acid/analogs & derivatives , Ascorbic Acid/therapeutic use , Atrophy , Benzoyl Peroxide/therapeutic use , Cicatrix/pathology , Clindamycin/therapeutic use , Combined Modality Therapy , Female , Glycolates/administration & dosage , Glycolates/adverse effects , Glycolates/therapeutic use , Humans , Japan , Male , Severity of Illness Index , Treatment Outcome , Young Adult , alpha-Tocopherol/administration & dosage , alpha-Tocopherol/adverse effects , alpha-Tocopherol/analogs & derivatives , alpha-Tocopherol/therapeutic use
12.
J Pediatr Surg ; 52(2): 309-312, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27912978

ABSTRACT

AIM OF THE STUDY: The treatment options for localized hyperhidrosis include antiperspirants, anticholinergics, iontophoresis, botulinum toxin and surgery. Tap water iontophoresis (TWI) involves immersing the affected area in tap water and passing a small electrical current through the area. Our aim was to assess the success of this therapy in a pediatric cohort. METHODS: Retrospective case note review of all patients younger than 18years who underwent TWI between 2002 and 2015. Demographic data, number of treatment sessions, side effects and overall success were analyzed. Individuals undergo 7 treatments over 4weeks. A positive outcome was determined as an improvement in symptoms. Pre- and posttreatment hyperhidrosis disease severity scale (HDSS) was measured. Data are presented as mean (range). Statistical analysis was by paired t-test. A P value of <0.05 was regarded as significant. RESULTS: There were 43 patients (30 females) with a mean age of 15 (8-17) years. Palmar and/or plantar hyperhidrosis (PPH) was present in 39/43 (91%) patients. Axillary hyperhidrosis (AH) was present in 19/43 (44%) patients. All patients (with the exception of one) underwent 7 sessions (5-7). Side effects included paresthesia (88%), pruritus (26%), pain (26%), erythema (14%), dryness (12%) as well as vesicle formation and abrasions in one patient (2%). A positive outcome was found in 84% (36/43) of patients. There was a significant reduction in mean HDSS (pre 3.5 vs. post 2; P=0.0001). CONCLUSION: TWI is a safe and effective modality of treatment for both PPH and AH in the pediatric population, with minimal side effects. Pediatric surgeons should offer this treatment option before considering more invasive surgical procedures. LEVEL OF EVIDENCE: IV: Retrospective study.


Subject(s)
Hyperhidrosis/therapy , Iontophoresis/methods , Water , Adolescent , Axilla , Child , Female , Foot , Hand , Humans , Hyperhidrosis/diagnosis , Iontophoresis/adverse effects , Male , Retrospective Studies , Severity of Illness Index , Treatment Outcome
13.
Headache ; 56(8): 1300-9, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27474357

ABSTRACT

OBJECTIVE: To evaluate the safety, tolerability, and pharmacokinetics of sumatriptan delivered by the iontophoretic transdermal system (TDS) in adolescent patients. BACKGROUND: Since nausea can be a prominent and early symptom of migraine, nonoral treatment options are often required. Sumatriptan iontophoretic TDS is approved for the acute treatment of migraine in adults. The present study evaluates the pharmacokinetics of sumatriptan administered via the iontophoretic TDS in adolescents, contrasting the findings with historical data from adults. DESIGN: Patients aged 12-17 years (inclusive) with acute migraine were treated with sumatriptan iontophoretic TDS for 4 hours. Blood samples for pharmacokinetic profiling of sumatriptan were obtained prior to dosing and at predetermined time points covering the 12 hours postonset of treatment. Key pharmacokinetic endpoints included Cmax (peak plasma drug concentration), tmax (time to Cmax ), AUC0-∞ (area under the plasma concentration-time curve from time 0 to infinity), and t½ (terminal elimination half-life). Safety was evaluated by monitoring of adverse events in addition to laboratory and clinical assessments. RESULTS: The sample consisted of 37 patients, and 36 were included in the PK evaluable population. Cmax , tmax , AUC0-∞ , and t½ values were all similar between male and female patients and between younger (12-14 years) and older (15-17 years) adolescents. When compared with historical adult data, adolescent patients demonstrated similar systemic exposures to those observed in adults (mean Cmax 20.20 (±6.43) ng/mL in adolescents vs 21.89 (±6.15) ng/mL in adults; mean AUC0-∞ 98.1 (±28.1) ng·h/mL in adolescents vs 109.7 (±26.1) ng·h/mL in adults). All adverse events were mild or moderate, with application-site paresthesia being the most common (32%). No clinically relevant changes in laboratory values, vital signs, or electrocardiogram findings were observed. CONCLUSIONS: The iontophoretic TDS produced mean systemic exposures to sumatriptan in younger and older adolescents, in line with what was seen in adult subjects. It was generally well tolerated.


Subject(s)
Migraine Disorders/drug therapy , Sumatriptan/administration & dosage , Vasoconstrictor Agents/administration & dosage , Administration, Cutaneous , Adolescent , Adult , Area Under Curve , Child , Cross-Over Studies , Female , Humans , Iontophoresis/adverse effects , Iontophoresis/methods , Male , Migraine Disorders/blood , Sumatriptan/adverse effects , Sumatriptan/pharmacokinetics , Vasoconstrictor Agents/adverse effects , Vasoconstrictor Agents/pharmacokinetics
14.
Eur J Pain ; 20(2): 215-22, 2016 Feb.
Article in English | MEDLINE | ID: mdl-25845368

ABSTRACT

BACKGROUND: Mechano-sensitive and mechano-insensitive C-nociceptors in human skin differ in receptive field sizes and electrical excitation thresholds, but their distinct functional roles are yet unclear. METHODS: After blocking the lateral femoral cutaneous nerve (NCFL) in eight healthy male subjects (3-mL Naropin(®) 1%), we mapped the skin innervation territory being anaesthetic to mechanical pin prick but sensitive to painful transcutaneous electrical stimuli. Such 'differentially anaesthetic zones' indicated that the functional innervation with mechano-sensitive nociceptors was absent but the innervation with mechano-insensitive nociceptors remained intact. In these areas, we explored heat pain thresholds, low pH-induced pain, cowhage- and histamine-induced itch, and axon reflex flare. RESULTS: In differentially anaesthetic skin, heat pain thresholds were above the cut-off of 50°C (non-anaesthetized skin 47 ± 0.4°C). Pain ratings to 30 µL pH 4 injections were reduced compared to non-anaesthetized skin (48 ± 9 vs. 79 ± 6 VAS; p < 0.01). The axon reflex flare area did not differ between these zones (7.8 ± 1.4 cm(2) vs. 8.3 ± 0.5 cm(2) ). Histamine iontophoresis still caused pruritus in differentially anaesthetized skin in five of eight subjects (VAS 26 ± 14), whereas itch upon cowhage spicules was absent (VAS 0 vs. 29 ± 11 in non-anaesthetized skin). CONCLUSIONS: We conclude that activation of mechano-insensitive nociceptors is sufficient to provoke itch by histamine- and acid-induced pain. The mechano-sensitive nociceptors are crucial for cowhage-induced itch and for the assessment of heat pain thresholds.


Subject(s)
Mechanoreceptors/physiology , Nociceptors/physiology , Pain Threshold/physiology , Pain/physiopathology , Pruritus/physiopathology , Skin/innervation , Adult , Histamine , Hot Temperature , Humans , Iontophoresis/adverse effects , Male , Pruritus/chemically induced , Young Adult
15.
Pain Manag ; 6(1): 19-24, 2016.
Article in English | MEDLINE | ID: mdl-26376128

ABSTRACT

OBJECTIVE: This analysis compared opioid-related adverse events (ORADEs) observed with fentanyl iontophoretic transdermal system (ITS) versus morphine intravenous (iv.) patient-controlled analgesia (PCA) in the management of postoperative pain. METHODS: Safety data from four Phase IIIB randomized, active-comparator trials were pooled for this analysis (n = 1288 fentanyl ITS and 1313 morphine iv. PCA patients). Treatment-emergent adverse events were collected via spontaneous report. In this post hoc analysis, ORADEs were defined as apnea, confusion, constipation, dyspnea, hypotension, hypoventilation, hypoxia, ileus, nausea, pruritus, somnolence, tachycardia, urinary retention and vomiting. Odds ratios (OR) and 95% CI were calculated for all ORADEs and p-values were based on logistic regression with treatment as effect. RESULTS: There were fewer patients in the fentanyl ITS group compared with the morphine iv. PCA group who experienced at least one ORADE (52.7 vs 59.1%, respectively; OR: 0.772: 95% CI: 0.661-0.901; p = 0.0011). The ORADEs that occurred less frequently in the fentanyl ITS group than in the morphine iv. PCA group included hypotension (3.7 vs 5.5%, respectively; OR: 0.667; 95% CI: 0.459-0.969; p = 0.0338), hypoventilation (0.9 vs 1.9%, respectively; OR: 0.444; 95% CI: 0.217-0.906; p = 0.0256), nausea (40.3 vs 44.5%, respectively; OR: 0.842; 95% CI: 0.721-0.984; p = 0.0310), pruritus (5.5 vs 9.4%, respectively; OR: 0.559; 95% CI: 0.413-0.757; p = 0.0002) and tachycardia (1.6 vs 2.8%, respectively; OR: 0.489; 95% CI: 0.277-0.863; p = 0.0136). No ORADEs occurred more frequently in the fentanyl ITS group compared with the morphine iv. PCA group. CONCLUSION: Fentanyl ITS, in the management of acute postoperative pain, offered safety advantages in terms of ORADEs compared with morphine iv. PCA.


Subject(s)
Analgesics, Opioid/adverse effects , Fentanyl/adverse effects , Morphine/adverse effects , Pain, Postoperative/drug therapy , Acetamides , Acute Pain/drug therapy , Administration, Cutaneous , Administration, Intravenous/adverse effects , Analgesia, Patient-Controlled/adverse effects , Female , Fentanyl/administration & dosage , Humans , Iontophoresis/adverse effects , Male , Middle Aged , Morphine/administration & dosage , Randomized Controlled Trials as Topic
16.
Int J Pediatr Otorhinolaryngol ; 79(12): 2416-23, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26611339

ABSTRACT

OBJECTIVES: Tympanostomy tube (tube) placement is the most common pediatric otolaryngologic surgery in the United States. Most surgeries are performed in an operating-room setting under general anesthesia due to the lack of tolerable and reliable local anesthesia methods suitable for pediatric patients, and concerns regarding myringotomy procedures in a mobile child. This study evaluated the safety and efficacy of an iontophoresis system (IPS) to achieve local anesthesia in combination with a tube delivery system (TDS) for tube placement in pediatric patients in an office setting. METHODS: A prospective, single-arm study was conducted at 9 otolaryngology sites in the United States. Participants included pediatric patients aged 6 months to less than 22 years requiring tube placement. Patients were prepared for the procedure using behavioral support techniques and tube placement was attempted under local anesthesia using the IPS in conjunction with the TDS. No physical restraints were allowed and no anxiolytics, analgesics, or sedatives were permitted. Safety was assessed through the occurrence of adverse events and success rates for tube placement under local anesthesia were determined. Tolerability of the procedure was evaluated using the 5-point Wong-Baker FACES Pain Rating Scale and parental satisfaction was assessed using a postoperative survey. RESULTS: Seventy patients (127 ears) were enrolled in the study [mean (SD) age=7.0 (3.9) years]. No serious adverse events occurred in the 70 enrolled patients. Tube placement using the TDS was successful in 96.6% (114/118) of attempted ears. A single TDS was required in 105 ears, while more than 1 device was required in 9 ears. Of the 70 patients enrolled in study, 63 (90.0%) successfully received tubes in all indicated ears during their in-office visit. The mean (SD) change in pain score from pre-anesthesia to post-surgery was +0.9 (1.8). Favorable ratings for overall satisfaction with the in-office procedure were obtained from 96.9% (63/65) of respondents. Tube retention at 2 weeks was 99.1%. As only 15 patients were enrolled who were 3 years old or younger, the ability to generalize these results to younger patients is limited. CONCLUSIONS: In this study, use of the IPS and TDS technologies enabled safe, reliable, and tolerable placement of tubes in awake, unrestrained pediatric patients.


Subject(s)
Anesthesia, Local/methods , Iontophoresis , Middle Ear Ventilation/methods , Pediatrics , Anesthesia, Local/adverse effects , Child , Child, Preschool , Female , Humans , Iontophoresis/adverse effects , Male , Middle Ear Ventilation/adverse effects , Middle Ear Ventilation/instrumentation , Office Visits , Pain, Postoperative/etiology , Patient Satisfaction , Prospective Studies , Treatment Outcome
17.
Br J Clin Pharmacol ; 80(2): 185-92, 2015 Aug.
Article in English | MEDLINE | ID: mdl-25753207

ABSTRACT

AIMS: Current-induced vasodilation (CIV) is an axon-reflex response observed during monopolar current application such as iontophoresis. Cyclo-oxygenase derivates (COD) participate in CIV and act as sensitizing agents at the anodal level. Mechanisms involved during cathodal current application (CCA) are partially unknown. In a randomized double-blind crossover trial, we tested in 16 healthy subjects (i) the influence of the inter-stimulation interval (I-I) by comparing CIV following all-at-once 10 s CCA against 2 × 5 s CCA with intervals ranging from15 s-16 min and (ii) the participation of COD in CIV using 1 g aspirin or placebo intake. METHODS: Measurements were repeated 2 h and 14 days after treatment. Laser Doppler flowmetry assessed cutaneous blood flow, reported in multiples of baseline. RESULTS: Before treatment, peak vasodilation 10 min after the last current application (CVCstim2 ) increased compared with baseline whatever the I-I. Increase in CVCstim2 from baseline was greater for the 4 min (9.4 (5.3, 10.9) times; median (1(st) percentile, 3(rd) percentile)) and higher I-Is compared with all-at-once delivery (3.0 (2.1, 4.3) times, P < 0.05). The response was similar after placebo but aspirin abolished this vasodilation (increase by 1.2 (1.1, 1.3) times for all-at-once delivery and by 1.5 (1.3, 1.7) ± 0.3 times for 4 min interval, 2 h after aspirin intake) that recovered after 14 days. CONCLUSIONS: This confirms the participation of COD in CIV with CCA and their sensitizing action. This model can represent an attractive way to study the axon-reflex and sensitizing function of COD in humans.


Subject(s)
Aspirin/pharmacology , Iontophoresis , Prostaglandin-Endoperoxide Synthases/physiology , Skin Physiological Phenomena , Skin/blood supply , Vasodilation , Aspirin/administration & dosage , Cross-Over Studies , Double-Blind Method , Female , Healthy Volunteers , Humans , Iontophoresis/adverse effects , Iontophoresis/methods , Laser-Doppler Flowmetry , Male , Microcirculation , Skin/drug effects , Skin/enzymology , Skin Physiological Phenomena/drug effects , Skin Temperature , Vasodilation/drug effects , Young Adult
18.
BMC Pulm Med ; 14: 198, 2014 Dec 13.
Article in English | MEDLINE | ID: mdl-25495771

ABSTRACT

BACKGROUND: The classic sweat test (CST) is the golden standard for cystic fibrosis (CF) diagnosis. Then, our aim was compare the production and volume of sweat, and side effects caused by pulsed direct current (PDC) and constant direct current (CDC). To determine the optimal stimulation time (ST) for the sweat collection. To verify the PDC as CF diagnosis option. METHODS: Prospective study with cross-sectional experimental intervention. Experiment 1 (right arm): PDC and CDC. ST at 10 min and sweat collected at 30 min. Currents of 0.5; 0.75; 1.0 and 1.5 mA and frequencies of 0, 200, 1,000 and 5,000 Hz applied. Experiment 2 (left arm): current of 1.0 mA, ST at 5 and 10 min and sweat collected at 15 and 30 min with frequencies of 0; 200; 1,000 and 5,000 Hz applied Experiments 1 and 2 were performed with current density (CD) from 0.07 to 0.21 mA/cm2. Experiment 3: PDC was used in typical CF patients with two CFTR mutations screened and or with CF diagnosis by rectal biopsy and patients with atypical CF. RESULTS: 48 subjects (79.16% female) with average of 29.54 ± 8.87 years old were enrolled. There was no statistical difference between the interaction of frequency and current in the sweat weight (p = 0.7488). Individually, positive association was achieved between weight sweat and stimulation frequency (p = 0.0088); and current (p = 0.0025). The sweat production was higher for 10 min of stimulation (p = 0.0023). The sweat collection was better for 30 min (p = 0.0019). The skin impedance was not influenced by ST and sweat collection (p > 0.05). The current frequency was inversely associated with the skin impedance (p < 0.0001). The skin temperature measured before stimulation was higher than after (p < 0.0001). In Experiment 3 (29 subjects) the PDC showed better kappa index compared to CDC (0.9218 versus 0.5205, respectively). CONCLUSIONS: The performance of the CST with CDC and PDC with CD of 0.14 to 0.21 mA/cm2 showed efficacy in steps of stimulation and collection of sweat, without side effects. The optimal stimulation time and sweat collection were, respectively, 10 and 30 min.


Subject(s)
Cystic Fibrosis/diagnosis , Electrodiagnosis/methods , Iontophoresis/methods , Sweat/metabolism , Adult , Biopsy , Chlorides/analysis , Electric Impedance , Electrodiagnosis/adverse effects , Female , Humans , Iontophoresis/adverse effects , Male , Muscarinic Agonists/pharmacology , Pilocarpine/pharmacology , Prospective Studies , Rectum/pathology , Sweat/chemistry , Sweat Glands/drug effects , Sweat Glands/physiopathology , Time Factors , Young Adult
19.
J Cutan Med Surg ; 18(2): 109-13, 2014.
Article in English | MEDLINE | ID: mdl-24636435

ABSTRACT

BACKGROUND: Patients tend to be noncompliant with tap water iontophoresis (TWI), which is an effective treatment option for palmoplantar hyperhidrosis. OBJECTIVE: To investigate compliance with TWI in patients with palmoplantar hyperhidrosis and identify the factors limiting its utility. METHODS: The medical data of 22 patients treated with TWI for palmoplantar hyperhidrosis were collected. A telephone inquiry questioning overall satisfaction with the treatment and the reasons for discontinuation was conducted. RESULTS: Sixteen patients completed the initial treatment period, and all responded well to the therapy. Eight patients started on the maintenance treatment, five of whom gave up before completing five sessions. The reasons for discontinuation were a lack of time in 12 patients, switching to home therapy in 3 patients, and side effects in 1 patient. CONCLUSION: Patients with palmoplantar hyperhidrosis are noncompliant with TWI, mainly due to a lack of time. They should be well informed before therapy and be encouraged to have a home device for maintenance.


Subject(s)
Hyperhidrosis/therapy , Iontophoresis/methods , Patient Compliance , Water/standards , Adolescent , Adult , Female , Humans , Hyperhidrosis/physiopathology , Iontophoresis/adverse effects , Male , Middle Aged , Patient Satisfaction , Retrospective Studies , Treatment Outcome , Visual Analog Scale , Young Adult
20.
Br J Clin Pharmacol ; 77(1): 63-71, 2014 Jan.
Article in English | MEDLINE | ID: mdl-23590287

ABSTRACT

Iontophoresis is a method of non-invasive transdermal drug delivery based on the transfer of charged molecules using a low-intensity electric current. Both local and systemic administration are possible; however, the skin pharmacokinetics of iontophoretically delivered drugs is complex and difficult to anticipate. The unquestionable theoretical advantages of the technique make it attractive in several potential applications. After a brief review of the factors influencing iontophoresis, we detail the current applications of iontophoresis in therapeutics and the main potential applications under investigation, including systemic and topical drugs and focusing on the treatment of scleroderma-related ulcerations. Finally, we address the issue of safety, which could be a limitation to the routine clinical use of iontophoresis.


Subject(s)
Iontophoresis/methods , Scleroderma, Localized/drug therapy , Skin Ulcer/drug therapy , Administration, Cutaneous , Analgesics/administration & dosage , Anesthetics, Local/administration & dosage , Anesthetics, Local/pharmacokinetics , Drug Delivery Systems/methods , Humans , Iontophoresis/adverse effects , Models, Biological , Pharmaceutical Preparations/administration & dosage , Scleroderma, Localized/complications , Skin Absorption , Skin Ulcer/complications , Vasoconstrictor Agents/administration & dosage , Vasoconstrictor Agents/pharmacokinetics , Vasodilator Agents/administration & dosage , Vasodilator Agents/pharmacokinetics
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