Exploring the safety and effectiveness of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy in chronic urticaria: An observer-blind, randomized, controlled study.

BACKGROUND: Autologous serum therapy aims to supplement the existing pharmacotherapy in chronic urticaria by decreasing the antihistamine pill-burden and maintaining symptom-free interval. Subcutaneous autologous serum therapy further modifies the amount of serum (2 mL to 1 mL) and gauge of a needle (24G to 31G) to improve compliance and facilitate ease of application. OBJECTIVES: To assess clinical effectiveness and safety of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy and to compare the quality of life in the two treatment arms. METHODS: Institution-based, assessor-blind, prospective, randomized, parallel-group, active-controlled trial with 32 patients in each treatment arm and analyzed on a modified intention to treat principle. After baseline autologous serum skin test, autologous serum was injected as per randomization every week for 9 consecutive weeks. RESULTS: Among the study population, conventional intramuscular autologous serum therapy and subcutaneous autologous serum therapy had a comparable duration of disease (P = 0.164, Mann-Whitney U test), autoreactive status (P = 0.796), urticaria total severity score (P = 0.637) and urticaria activity score summed up over 7 days (P = 0.982). Both urticaria activity score summed up over 7 days and total severity score along with antihistamine pill-burden reduced significantly (P < 0.001, Friedman's analysis of variance) in both subcutaneous autologous serum therapy and conventional intramuscular autologous serum therapy from first follow-up onwards (P < 0.05, Post hoc Dunn's test). Significant improvement was noted in patient's as well as physician's global assessment of disease activity improvement scale (P < 0.001, Friedman's analysis of variance). Intergroup analysis showed that there was no significant difference in urticaria activity score summed up over 7 days either at baseline (P = 0.982, Mann-Whitney U test) or at study end (P = 0.398, Mann-Whitney U test). Similar comparable results were found in the total severity score at the end of the study (P = 0.345, Mann-Whitney U test). Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test). The pain score at the injection site was more with conventional intramuscular autologous serum therapy than subcutaneous autologous serum therapy (P = 0.0115, Mann-Whitney test). Younger age and lower baseline total severity scores were associated with a better therapeutic response. Baseline urticaria activity score added up over a period of 7 days and total severity scores and the diameter of lesions showed a positive correlation with response pattern. LIMITATION: Basophil histamine release assay not done. Logistics could not support follow-up beyond the end of treatment. CONCLUSION: Subcutaneous autologous serum therapy is not inferior to conventional intramuscular autologous serum therapy with the additional advantage of less pain and operational feasibility.

Effectiveness and safety of autologous platelet-rich plasma therapy with total contact casting versus total contact casting alone in treatment of trophic ulcer in leprosy: An observer-blind, randomized controlled trial.

BACKGROUND: Trophic ulcers secondary to leprosy pose a great stigma to patients and remain a challenge to the treating dermatologists. Platelet-rich plasma (PRP) introduces growth factors directly into the wound and aids in rapid healing. The role of PRP in the treatment of trophic ulcers in leprosy patients has not yet been established by randomized controlled trials. AIMS: To study the effectiveness and safety of autologous PRP therapy with total contact casting versus total contact casting alone in the treatment of trophic ulcers in leprosy. METHODS: In an observer-blind, randomized (1:1) controlled study, 118 patients were enrolled. PRP was prepared by the manual double-spin method (1600 rpm for 10 min followed by 4000 rpm for 10 min). After wound bed preparation, activated PRP was injected intra- and perilesionally, and platelet-poor plasma gel was applied over the ulcer bed. Occlusive dressings and total contact casting were then applied in Group A, and only total contact casting was applied in Group B. The same procedure was repeated every 2 weeks for 8 weeks. RESULTS: In all, 56 patients were analyzable in Group A and 52 in Group B. The surface area of the ulcer decreased significantly from first follow-up onward in both the groups (P < 0.001 in both the groups). Intergroup comparison showed that the reduction in the surface area of the ulcer was significantly more in Group A than in Group B from the first follow-up onward (P = 0.038) and the difference was maintained till the fifth follow-up (P < 0.001). At the end of the study, 91.10 ± 9.65% ulcer surface area reduction had occurred in Group A, whereas it was 79.77 ± 17.91% in Group B (P < 0.001). Trophic ulcers healed completely more often in paucibacillary leprosy patients (P < 0.001) and in those with a lower initial surface area of the ulcer (P < 0.001). LIMITATION: Short duration of treatment (8 weeks). CONCLUSION: PRP combined with total contact casting accelerates the healing of trophic ulcers of leprosy and is more effective than total contact casting alone. Complete remission is more likely to occur when the duration and surface area of ulcer are less and in the paucibacillary spectrum.

A randomized study to evaluate the efficacy and effectiveness of two sunscreen formulations on Indian skin types IV and V with pigmentation irregularities.

BACKGROUND: Regular exposure to ultraviolet rays is high in India, where most Indians present Fitzpatrick skin phototypes IV and V. AIMS: To evaluate the efficacy and compare the effectiveness of two sunscreen products on Indian skin types IV and V with pigmentation irregularities. METHODS: A randomized, uncontrolled and investigator-blinded, single-center study enrolled adult men and women (18-45 years) with Fitzpatrick skin phototypes IV (28° < individual typological angle <10°) and V (10° < individual typological angle < -30°) with pigmentary abnormalities seen on the face in adults (actinic lentigines and postinflammatory hyperpigmentation), who did not use sunscreens. Participants were randomized (1:1) to either of the two marketed sunscreen products, Product A (sun protection factor 50 PA+++) or Product B (sun protection factor 19 PA+++), applied twice daily before sun exposure for ≥2 h. Primary objectives aimed at assessing possible improvement in hyperpigmented spots and overall skin appearance after 12 weeks of use. Evaluation of skin radiance and skin color was done by means of L'Oréal color chart and colorimetric measurements (Chromameter®). RESULTS: Among the 230 enrolled participants, 216 (93.91%) completed the study. The clinical assessment of the density of pigmented spots and skin radiance showed significant (P < 0.001) improvement in both groups during all visits. The qualitative (participant perception) and quantitative (Chromameter®) data indicated improvement in pigmentation from Week 0 to Week 12. Both products were well-tolerated. LIMITATIONS: The study was conducted over a rather short period of time (12 weeks) at a single location. CONCLUSIONS: This is the first study conducted on Indian skin phototypes IV and V under real-life conditions. It demonstrated the effect of regular sunscreen usage in the prevention of certain signs of skin photoaging such as increased pigmentation or pigmentary abnormalities, thus providing support and assistance to clinicians in suggesting the use of efficient sun-screening products to patients.

Topical sirolimus for the treatment of angiofibromas in tuberous sclerosis.

BACKGROUND: The skin is one of the most affected organs in tuberous sclerosis complex and angiofibromas are seen in almost 80% of such patients. These benign tumors impose a great psycho-social burden on patients. OBJECTIVE: The aim of the study was to evaluate the effectiveness and tolerability of topical sirolimus for facial angiofibromas in patients with tuberous sclerosis complex. METHODS: This was a prospective, single-blinded, cross-over study which involved twelve patients. We investigated the effect and safety of topical 0.1% sirolimus, which was obtained by crushing sirolimus tablets and mixing it with petrolatum. The patients were asked to apply the cream to one side of their face, and vaseline to the other side. The effect of topical sirolimus was evaluated using the "facial angiofibroma severity index." RESULTS: There was a significant improvement in the redness and extension of the tumors on the sides to which the active ingredient was applied. Some side effects such as itching and irritation occurred in three patients, which were treated with topical hydrocortisone cream. CONCLUSION: Topical sirolimus appears to be a promising, fairly well tolerated treatment for facial angiofibromas in patients with tuberous sclerosis complex. Although its efficacy diminishes with time, repetitive usage is effective.

Superiority of dutasteride over finasteride in hair regrowth and reversal of miniaturization in men with androgenetic alopecia: A randomized controlled open-label, evaluator-blinded study.

BACKGROUND: Finasteride and dutasteride are inhibitors of the enzyme 5-alpha-reductase which inhibits the conversion of testosterone to dihydrotestosterone. Dutasteride inhibits both type I and type II 5-alpha-reductase while finasteride inhibits only the type II enzyme. As both isoenzymes are present in hair follicles, it is likely that dutasteride is more effective than finasteride. AIMS: To compare the efficacy, safety and tolerability of dutasteride and finasteride in men with androgenetic alopecia. METHODS: Men with androgenetic alopecia between 18 and 40 years of age were randomized to receive 0.5 mg dutasteride or 1 mg finasteride daily for 24 weeks. The primary efficacy variables were hair counts (thick and thin) in the target area from modified phototrichograms and global photography evaluation by blinded and non-blinded investigators. The secondary efficacy variable was subjective assessment using a preset questionnaire. Patients were assessed monthly for side effects. RESULTS: Ninety men with androgenetic alopecia were recruited. The increase in total hair count per cm[2] representing new growth was significantly higher in dutasteride group (baseline- 223 hair; at 24 weeks- 246 hair) compared to finasteride group (baseline- 227 hair; at 24 weeks- 231 hair). The decrease in thin hair count per cm[2] suggestive of reversal of miniaturization was significantly higher in dutasteride group (baseline- 65 hair; at 24 weeks- 57 hair) compared to finasteride group (baseline- 67 hair; at 24 weeks- 66 hair). Both the groups showed a similar side effect profile with sexual dysfunction being the most common and reversible side effect. LIMITATIONS: Limitations include the short duration of the study (6 months), the small sample size and the fact that it was an open-label study. CONCLUSIONS: Dutasteride was shown to be more efficacious than finasteride and the side-effect profiles were comparable.

Comparison of the effects of remifentanil and remifentanil plus lidocaine on intubation conditions in intellectually disabled patients.

BACKGROUND AND OBJECTIVES: This is a prospective, randomized, single-blind study. We aimed to compare the tracheal intubation conditions and hemodynamic responses either remifentanil or a combination of remifentanil and lidocaine with sevoflurane induction in the absence of neuromuscular blocking agents. METHODS: Fifty intellectually disabled, American Society of Anesthesiologists I-II patients who underwent tooth extraction under outpatient general anesthesia were included in this study. Patients were randomized to receive either 2 µg kg(-1) remifentanil (Group 1, n=25) or a combination of 2 µg kg(-1) remifentanil and 1 mg kg(-1) lidocaine (Group 2, n=25). To evaluate intubation conditions, Helbo-Hansen scoring system was used. In patients who scored 2 points or less in all scorings, intubation conditions were considered acceptable, however if any of the scores was greater than 2, intubation conditions were regarded unacceptable. Mean arterial pressure, heart rate and peripheral oxygen saturation (SpO2) were recorded at baseline, after opioid administration, before intubation, and at 1, 3, and 5 min after intubation. RESULTS: Acceptable intubation parameters were achieved in 24 patients in Group 1 (96%) and in 23 patients in Group 2 (92%). In intra-group comparisons, the heart rate and mean arterial pressure values at all-time points in both groups showed a significant decrease compared to baseline values (p=0.000) CONCLUSION: By the addition of 2 µg/kg remifentanil during sevoflurane induction, successful tracheal intubation can be accomplished without using muscle relaxants in intellectually disabled patients who undergo outpatient dental extraction. Also worth noting, the addition of 1mg/kg lidocaine to 2 µg/kg remifentanil does not provide any additional improvement in the intubation parameters.

Comparison of the effects of remifentanil and remifentanil plus lidocaine on intubation conditions in intellectually disabled patients / Comparação dos efeitos de remifentanil e remifentanil + lidocaína em intubação de pacientes intelectualmente deficientes / Comparación de los efectos del remifentanilo y el remifentanilo más lidocaína en intubación de pacientes intelectualmente discapacitados

BACKGROUND AND OBJECTIVES: This is a prospective, randomized, single-blind study. We aimed to compare the tracheal intubation conditions and hemodynamic responses either remifentanil or a combination of remifentanil and lidocaine with sevoflurane induction in the absence of neuromuscular blocking agents. METHODS: Fifty intellectually disabled, American Society of Anesthesiologists I-II patients who underwent tooth extraction under outpatient general anesthesia were included in this study. Patients were randomized to receive either 2 μg kg-1 remifentanil (Group 1, n = 25) or a combination of 2 μg kg-1 remifentanil and 1 mg kg-1 lidocaine (Group 2, n = 25). To evaluate intubation conditions, Helbo-Hansen scoring system was used. In patients who scored 2 points or less in all scorings, intubation conditions were considered acceptable, however if any of the scores was greater than 2, intubation conditions were regarded unacceptable. Mean arterial pressure, heart rate and peripheral oxygen saturation (SpO2) were recorded at baseline, after opioid administration, before intubation, and at 1, 3, and 5 min after intubation. RESULTS: Acceptable intubation parameters were achieved in 24 patients in Group 1 (96%) and in 23 patients in Group 2 (92%). In intra-group comparisons, the heart rate and mean arterial pressure values at all-time points in both groups showed a significant decrease compared to baseline values (p = 0.000) CONCLUSION: By the addition of 2 μg/kg remifentanil during sevoflurane induction, successful tracheal intubation can be accomplished without using muscle relaxants in intellectually disabled patients who undergo outpatient dental extraction. Also worth noting, the addition of 1 mg/kg lidocaine to 2 μg/kg remifentanil does not provide any additional improvement in the intubation parameters. .

JUSTIFICATIVA E OBJETIVOS: este é um estudo prospectivo, randômico e duplo-cego. Nosso objetivo foi comparar as condições de intubação endotraqueal e as respostas hemodinâmicas com o uso de remifentanil ou combinação de remifentanil e lidocaína em indução anestésica com sevoflurano sem agentes bloqueadores neuromusculares. MÉTODOS: cinquenta pacientes intelectualmente deficientes, estado físico ASA I-II, submetidos à extração dentária sob anestesia geral em ambulatório foram incluídos neste estudo. Os pacientes foram randomizados para receber 2 μg kg-1 de remifentanil (Grupo 1, n = 25) ou uma combinação de 2 μg kg-1 de remifentanil e 1 mg kg-1 de lidocaína (Grupo 2, n = 25). Para avaliar as condições de intubação, o sistema de pontuação de Helbo-Hansen foi usado. Em pacientes com 2 ou menos pontos em todas as pontuações, as condições de intubação foram consideradas aceitáveis, porém, se qualquer uma das pontuações fosse superior a 2, as condições de intubação seriam consideradas inaceitáveis. Pressão arterial média, frequência cardíaca e saturação periférica de oxigênio (SpO2) foram registradas no início do estudo, após a administração de opiáceos, antes da intubação e nos minutos 1, 3 e 5 após a intubação. RESULTADOS: parâmetros aceitáveis de intubação foram obtidos em 24 pacientes do Grupo 1 (96%) e em 23 pacientes do Grupo 2 (92%). Nas comparações intragrupo, os valores da frequência cardíaca e pressão arterial média em todos os momentod em ambos os grupos mostraram uma redução significativa em relação aos valores basais (p = 0.000). ...

JUSTIFICACIÓN Y OBJETIVOS: este es un estudio prospectivo, aleatorizado y doble ciego. Nuestro objetivo fue comparar las condiciones de intubación endotraqueal y las respuestas hemodinámicas con el uso de remifentanilo o la combinación de remifentanilo y lidocaína en inducción anestésica con sevoflurano sin agentes bloqueantes neuromusculares. MÉTODOS: cincuenta pacientes intelectualmente discapacitados, estado físico ASA I-II, sometidos a la extracción dental bajo anestesia general en ambulatorio fueron incluidos en este estudio. Los pacientes fueron aleatorizados para recibir 2 μg/kg-1 de remifentanilo (grupo 1, n = 25) o una combinación de 2 μg/kg-1 de remifentanilo y 1 mg/kg-1 de lidocaína (grupo 2, n = 25). Para evaluar las condiciones de intubación se usó el sistema de puntuación de Helbo-Hansen. En pacientes con 2 o menos puntos en todas las puntuaciones, las condiciones de intubación fueron consideradas aceptables, sin embargo, si cualquiera de las puntuaciones fuese superior a 2 las condiciones de intubación serían consideradas inaceptables. La presión arterial media, frecuencia cardíaca y la saturación periférica de oxígeno, fueron registradas al inicio del estudio, después de la administración de opiáceos, antes de la intubación y en los minutos 1, 3 y 5 después de la intubación. RESULTADOS: se obtuvieron parámetros aceptables de intubación en 24 pacientes del grupo 1 (96%) y en 23 pacientes del grupo 2 (92%).En las comparaciones intragrupo, los valores de la frecuencia cardíaca y la presión arterial media en todos los momentos en ambos grupos arrojaron una reducción significativa con relación a los valores basales (p = 0,000). CONCLUSIÓN: con la adición de 2 μg/kg de remifentanilo durante la inducción con sevoflurano ...

The prevalence of dementia and depression in Taiwanese institutionalized leprosy patients, and the effectiveness evaluation of reminiscence therapy--a longitudinal, single-blind, randomized control study.

OBJECTIVE: This study investigated the prevalence of depression and dementia in long-term institutionalized older leprosy patients in Taiwan. We then examined the effectiveness of reminiscence group therapy on depressive symptoms and cognitive function in this population. METHODS: We recruited 129 long-term institutionalized older leprosy patients in Taiwan and used the Geriatric Depression Scale-Short Form (GDS-SF), the mini mental state examination (MMSE), and the Clinical Dementia Rating (CDR) scale for outcome measurement. We then conducted a single-blind, randomized, longitudinal quasi-experimental analysis comparing the pre-test and post-test results of two equivalent groups at a 24-week intervention interval. The intervention in the experimental group was three sessions of reminiscence group therapy per week, whereas that in the control group was weekly individual supportive interviews. RESULTS: The prevalence of dementia was 45.7-50.4% according to a CDR score ≥ 0.5 and an MMSE score < 25, and the prevalence of depression was 25% based on a GDS-SF score ≥ 7. According to the Wilcoxon signed-rank test, the GDS-SF scores in the experimental group decreased significantly (p = 0.02) after intervention as compared with that in the control group (p = 0.22), whereas the MMSE scores in both groups remained steady. CONCLUSIONS: The prevalence of dementia and depression in long-term institutionalized older leprosy patients in Taiwan is high. Reminiscence group therapy has been confirmed effective on depression in this population, but its effectiveness on cognitive function requires further verification.

Laparoscopic sigmoid resection for diverticular disease has no advantages over open approach: midterm results of a randomized controlled trial.

PURPOSE: Elective laparoscopic sigmoid resection (LSR) for symptomatic diverticular disease is supposed to have significant short-term advantages compared to open surgery (open sigmoid resection (OSR)). This opinion is rather based on inferences from trials on colonic resections for malignant diseases or minor laparoscopic surgery. This randomized controlled trial was conducted to compare quality of life as well as morbidity and clinical outcome after LSR vs. OSR following a midterm follow-up period. METHODS: Patients presenting with a symptomatic sigmoid diverticular disease stage II/III (Stock/Hansen) were randomly allocated to LSR or OSR in a prospective multicenter trial. Endpoints included the quality of life assessed with a standardized questionnaire, postoperative mortality, and complications within the follow-up of 12 months after operation. RESULTS: A total of 143 patients randomized between 2005 and 2008 in 12 centers could be analyzed. The recruitment was aborted for nonachievement of the planned sample size. Seventy-five patients were allocated to LSR, and 68 received OSR. Nine operations were converted to OSR (9%) and analyzed as intention to treat. Groups were comparable for age, gender, body mass index, comorbidity, and indication for surgery. Operation time was longer for LSR (p < 0.001). Quality of life did not differ between LSR and OSR, either during the early postoperative course or after 12 months (p = 0.172). Also, mortality and morbidity, including subgroups of major and minor morbidity, were compared. CONCLUSION: LSR was not superior to OSR regarding postoperative quality of life and incidence of complications in this trial.

[Reliability and agreement of two smear reading scales for classification and monitoring of multidrug therapy in leprosy patients]. / Confiabilidad y concordancia de dos escalas de lectura de baciloscopias para clasificación y seguimiento del tratamiento con múltiples medicamentos de los pacientes con lepra.

INTRODUCTION: After the clinical diagnosis of leprosy, classification methods are necessary to define a treatment and prognosis of patients consistent with bacterial load. Bacteria are detected in skin smear, and bacterial load typically is established by the internationally used Ridley's logarithmic scale, However, in Colombia an alternative semiquantitative scale is used. OBJECTIVE: The interobserver reproducibility was established for the Ridley and Colombia scales, and the level of correlation-matching was identified between the bacillary indices obtained in order to assess the degree of interchangeability. MATERIALS AND METHODS: Standardization was attained by a reading of the smears by 2 readers with subsequent, blinded evaluation of inter-observer agreement. Each reader quantified the bacterial load of for each sample (n=325) using the Colombian and the Ridley scales. The degree of interobserver agreement was assessed with weighted kappa coefficient. The level of correlation and agreement between the measurements of the bacillary index was established with coefficient of Lin. RESULTS: The interobserver weighted kappa coefficient was 0.83 for the Colombia scale and 0.85 for the Ridley scale. The Lin coefficient was 0.96 for the correlation-matching of bacillary indexes. CONCLUSIONS: Interobserver agreement obtained for both scales was excellent as the correlation-matching bacillary indices determined with both methods. With the cut-off points yielded a good level of agreement, ensuring interchangeability between the scales defining the high or low bacterial load.

Clindamycin lotion alone versus combination lotion of clindamycin phosphate plus tretinoin versus combination lotion of clindamycin phosphate plus salicylic acid in the topical treatment of mild to moderate acne vulgaris: a randomized control trial.

BACKGROUND: Acne vulgaris is a common skin disease that affects 85% to 100% of people at some time during their lives. It is characterized by noninflammatory follicular papules or comedones and by inflammatory papules, pustules, and nodules in its more severe forms. AIMS: To compare the efficacy of combination treatment of clindamycin+salicylic acid, versus clindamycin+tretinoin versus clindamycin alone in the treatment of the mild-to-moderate acne vulgaris. METHODS: This was a single-blinded, randomized clinical trial.Forty-two female patients (age range: 15-25 years) with mild-to-moderate acne vulgaris were selected randomly and subsequently randomized to 3 groups. Group A patients were treated with 1% clindamycin lotion (C lotion) twice daily. Group B patients were treated with 1% clindamycin+0.025% tretinoin lotion once nightly (CT lotion). Group C patients were treated with 1% clindamycin+2% salicylic acid lotion twice daily (CS lotion) for 12 weeks. For comparison of efficacy of these treatments, and regarding the skewed distribution of the data, Kruskal-Wallis Test and Mann-Whitney U test were used. SPSS software was used for statistical analysis. RESULTS: There was a significant difference between 3 types of treatment in the respect of the total lesion count (TLC) improvement (P = 0.039). The efficacy of treatment on Acne Severity Index (ASI) was maximum for CS lotion (81.80% reduction in ASI). CT lotion reduced ASI by as much as 73.73% during 12 weeks of treatment. The efficacy of C lotion was calculated to be 37.87% in the reduction of ASI. CONCLUSIONS: Our data suggested that the efficacy of CS lotion was significantly more than C lotion with respect to the TLC and ASI, although there was no significant difference between CS and CT lotion.

Comparison of intralesional verapamil with intralesional triamcinolone in the treatment of hypertrophic scars and keloids.

BACKGROUND: The calcium channel blocker, verapamil stimulates procollagenase synthesis in keloids and hypertrophic scars. AIM: To study the effect of verapamil in the treatment of hypertrophic scars and keloids and to evaluate the effect of verapamil on the rate of reduction of hypertrophic scars and keloids in comparison with triamcinolone. METHODS: The study was a randomized, single blind, parallel group study in which 54 patients were allocated to to receive either verapamil or triamcinolone. Drugs were administered intralesionally in both groups. Improvement of the scar was measured using modified Vancouver scale and by using a centimeter scale serially till the scar flattened. RESULTS: There was a reduction in vascularity, pliability, height and width of the scar with both the drugs after 3 weeks of treatment. These changes were present at one year of follow-up after stopping treatment. Scar pigmentation was not changed desirably by either drug. Length of the scars was also not altered significantly by either drug. The rate of reduction in vascularity, pliability, height and width of the scar with triamcinolone was faster than with verapamil. Adverse drug reactions were more with triamcinolone than with verapamil. CONCLUSION: Intralesional verapamil may be a suitable alternative to triamcinolone in the treatment of hypertrophic scars and keloids.

An open randomized comparative study to test the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in the treatment of onychomycosis.

BACKGROUND: Onychomycosis is a fungal infection of nails caused by dermatophytes, yeasts and molds. AIMS: To study the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in onychomycosis. METHODS: A clinical comparative study was undertaken on 96 Patients of onychomycosis during the period between August 2005 to July 2006. Forty-eight patients were randomly assigned in group A to receive oral terbinafine 250 mg, one tablet twice daily for seven days every month (pulse therapy); 24 patients in group B to receive oral terbinafine pulse therapy plus topical ciclopirox olamine 8% to be applied once daily at night on all affected nails; and 24 patients in group C to receive oral terbinafine pulse therapy plus topical amorolfine hydrochloride 5% to be applied once weekly at night on all the affected nails. The treatment was continued for four months. The patients were evaluated at four weekly intervals till sixteen weeks and then at 24 and 36 weeks. RESULTS: We observed clinical cure in 71.73, 82.60 and 73.91% patients in groups A, B and C, respectively; Mycological cure rates against dematophytes were 88.9, 88.9 and 85.7 in groups A, B and C, respectively. The yeast mycological cure rates were 66.7, 100 and 50 in groups A, B and C, respectively. In the case of nondermatophytes, the overall response was poor: one out of two cases (50%) responded in group A, while one case each in group B and group C did not respond at all. CONCLUSION: Terbinafine pulse therapy is effective and safe alternative in treatment of onychomycosis due to dermatophytes; and combination therapy with topical ciclopirox or amorolfine do not show any significant difference in efficacy in comparison to monotherapy with oral terbinafine.

Comparative potency of formulations of mometasone furoate in terms of inhibition of 'PIRHR' in the forearm skin of normal human subjects measured with laser doppler velocimetry.

BACKGROUND AND AIMS: Topical glucocorticoid formulations are widely used for effective treatment and control of a variety of dermatoses. Mometasone furoate is a newer corticoid that has high potency but low systemic toxicity. Pharmaceutical factors are known to significantly influence potency and systemic absorption of topically applied glucocorticoids. We studied the potency of "Elocon", a topical formulation of mometasone furoate, compared with two other branded formulations of the same corticoid. METHODS: Corticoid potency was measured by employing a pharmacodynamic parameter of an inhibitory effect of the corticoid on post-ischemic-reactive-hyperemic-response (PIRHR) in human forearm skin under occlusive dressing. The PIRHR was expressed in terms of % increase in the skin blood flow (SBF) as measured with laser doppler velocimetry (LDV). RESULTS: All three active branded formulations of mometasone furoate produced significant inhibition of PIRHR. The AUC(0-2 min) of PIRHR was ( Mean +/- SEM ), Control = 213.52 +/- 11.80, Placebo = 209.77 +/- 19.31, Formulation A = 119.83 +/- 13.71, Formulation C = 53.67 +/- 4.85 and Formulation D = 111.46 +/- 22.87. Formulation "C" exhibited significantly higher topical anti-inflammatory potency than formulations "A" or "D". CONCLUSIONS: Thus, branded formulations of the same glucocorticoid, mometasone furoate significantly differed in their topical anti-inflammatory potency. "Elocon" was significantly more potent than the two other branded formulations studied.

An open randomized comparative study of oral itraconazole pulse and terbinafine pulse in the treatment of onychomycosis.

BACKGROUND: Onychomycosis is a recalcitrant disease of the nails caused by dermatophytes, yeasts, and molds. AIMS: To compare the clinical efficacy of oral itraconazole pulse therapy and oral terbinafine pulse therapy in onychomycosis. METHODS: A randomized single-blind clinical comparative study was undertaken on 120 patients of onychomycosis during the period March 1999-February 2002. Sixty patients were randomly assigned to receive oral itraconazole 100 mg, two capsules twice daily for seven days a month and the other group of sixty patients received oral terbinafine 250 mg, one tablet twice daily for seven days every month. Four such monthly pulses were administered for each drug. The patients were evaluated at 4-weekly intervals till sixteen weeks and then at 24, 36 and 48 weeks. RESULTS: We observed a clinical cure rate of 82% and mycological cure rate of 90% in the group of patients treated with itraconazole while the group with terbinafine showed clinical and mycological cure rates of 79% and 87% respectively. This difference was not statistically significant. CONCLUSIONS: Both oral itraconazole and terbinafine are effective in the treatment of onychomycosis when administered in the pulse dosage form. Terbinafine is more cost effective while itraconazole has a broader spectrum of antimycotic activity.

Reactional states and neuritis in multibacillary leprosy patients following MDT with/without immunotherapy with Mycobacterium w antileprosy vaccine.

A vaccine based on autoclaved Mycobacterium w was administered, in addition to standard multidrug therapy (MDT), to 157 untreated, bacteriologically positive, lepromin negative multibacillary leprosy patients, supported by a well matched control group of 147 patients with similar type of disease, who received a placebo injection in addition to MDT. The MDT was given for a minimum period of 2 years and continued until skin smear negativity, while the vaccine/placebo was given at 3-monthly intervals up to a maximum of eight doses. The incidence of type 2 reaction and neuritis during treatment and follow-up showed no statistically significant difference in the vaccine and placebo groups. The incidence of type 1 reaction (mild in most cases), however, was higher in the vaccine group (P = 0.041, relative risk ratio 1.79), considering LL, BL and BB leprosy types together, and considerably higher (P = 0.009) in LL type, probably because of confounding due to higher number of patients with previous history of reaction in this group. The occurrence of reactions and neuritis in terms of single or multiple episodes was similar in the vaccine and placebo groups. The association of neuritis and reactions, as well as their timing of occurrence (during MDT or follow-up), was also similar in the two groups, with more than 90% of occurrences taking place during MDT. The incidence of reversal reaction was significantly higher among the males in the vaccine group (34.5% versus 8.3%, P = 0.019). Patients with high initial BI (4.1-6.0) showed higher incidence of reactions (70.3%) as compared to those with medium (2.1-4.0) and low (0.3-2.0) BI where the reactions were observed with a frequency of 56.1% and 38.8%, respectively. However, unlike reactions, neuritis incidence did not seem to be affected by initial BI to the same extent in the vaccine group, with frequencies of 35.3%, 36.3% and 25.9% in the three mentioned BI ranges. Overall, the vaccine did not precipitate reactional states and neuritis over and above that observed with MDT alone.

Induction of lepromin positivity following immuno-chemotherapy with Mycobacterium w vaccine and multidrug therapy and its impact on bacteriological clearance in multibacillary leprosy: report on a hospital-based clinical trial with the candidate antileprosy vaccine.

A vaccine based on autoclaved Mycobacterium w was administered, in addition to standard multidrug therapy (MDT), to 157 bacteriologically positive, lepromin-negative, multibacillary (LL, BL and BB) leprosy patients. The vaccinees were supported by a well-matched control group of 147 patients with similar type of disease who received a placebo injection in addition to MDT. The MDT was given for a minimum period of 2 years and continued until skin-smear negativity, while the vaccine was given at 3-month intervals up to a maximum of 8 doses. The lepromin response evaluated in terms of percentage of subjects converting to positivity status, measurement in millimeters, and duration of lepromin positivity sustained, reflected a statistically significant better outcome in the vaccine group patients (especially LL and BL leprosy) in comparison to those in the placebo group. The data indicate that lepromin-positivity status seems to have an impact on accelerating the bacteriological clearance, as is evident by the statistically significant accelerated decline in the BI of those patients who converted to lepromin positivity as compared to those remaining lepromin negative throughout therapy and post-therapy follow up. To conclude, the addition of the Mycobacterium w vaccine to standard MDT induces a lepromin response of a statistically significant higher magnitude than that observed with MDT alone.

Reversal reaction in multibacillary leprosy patients following MDT with and without immunotherapy with a candidate for an antileprosy vaccine, Mycobacterium w.

Immunotherapy with a candidate for an antileprosy vaccine, Mycobacterium w, was given in addition to standard multidrug therapy (MDT) to 53 multibacillary lepromin negative patients belonging to BB, BL and LL types of leprosy (vaccine group). An equal control group received MDT and injections of micronized starch as placebo. Both the vaccine and placebo were administered intradermally every 3 months. The patients were evaluated at determined intervals by clinical, bacteriological and histopathological parameters and lepromin testing. Reactional episodes were analysed with reference to incidence, onset, frequency and severity during and after release from treatment (RFT). Incidence of reversal reaction (RR) was marginally higher in the vaccine group (22.6% vaccine group vs 15% control group). All cases with a history of downgrading type 1 reaction developed RR during therapy. Most episodes occurred within the 1st year of the commencement of therapy--50% developing within 3 months. Late reversal reaction (after RFT) were observed in 3.8% of cases in both groups, and 50% of the reactors in the control group and 33% in the vaccine group had repeated reactional episodes. Incidence of neuritis associated with RR as well as isolated neuritis was similar in both groups.