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1.
J Ethnopharmacol ; 298: 115603, 2022 Nov 15.
Article in English | MEDLINE | ID: mdl-35940465

ABSTRACT

ETHNOPHARMACOLOGICAL RELEVANCE: Pityriasis Versicolor (PV) is a commonly encountered infection of the skin caused by Malassezia species. Despite effective conventional antifungal drugs, the prevention and treatment of PV remain a challenge. The Unani pharmacopoeial preparations Itrifal Hakim Ali (IHA) and Habb-e-Kalaf (HK) have been used in the treatment of PV for a long time. The Unani practitioners recommend these formulations for the successful treatment of PV in clinical practice. AIM OF THE STUDY: This study aimed to evaluate the efficacy and safety of Unani formulations IHA (oral) and HK (topical) in the treatment of PV. MATERIALS AND METHODS: A single centre, randomized, active-controlled, parallel-group and open-label clinical study was carried out in the outpatient departments of the National Research Institute of Unani Medicine for Skin Disorders, Hyderabad, India. The participants diagnosed with PV of any gender aged between 18 and 60 years were randomized into the test group (n = 37) to receive oral IHA (10g/day) and topical HK and the active control group (n = 35) to receive oral Itraconazole (100 mg/day) and local Terbinafine (1%) for the period of 6 weeks. Of them, 30 participants in each group completed the duration of the protocol therapy. The outcome of this study was based on a per-protocol analysis of the data. The efficacy of the interventions was measured by post-treatment change in subjective clinical symptoms/signs, mean TSSS, IGA score, direct microscopy of fungal elements and DLQI. The dermal safety was assessed by Berger/Bowman Scoring Scale and systemic safety was evaluated by Urinalysis, haematological and biochemical parameters. RESULTS: This study observed statistically and clinically significant post-treatment reduction in itching (test group vs. active control group; 73.4% vs. 89.1%), hypopigmentation (63.2% vs. 57.1%), hyperpigmentation (60% vs. 65.5%), and scaling (91.6% vs. 92.7%) (p < 0.001). The differences in mean TSSS (5.4 ± 0.63 vs. 5.60 ± 0.32), IGA score (2.07 ± 0.15 vs. 1.74 ± 0.08) and DLQI (9.6 ± 2.06 vs. 9.04 ± 2.7) were also found clinically and statistically significant (p < 0.001) in each group when compared baseline data to post-treatment. On inter-group comparison, the changes in mean TSSS and DLQI were not found statistically significant at p < 0.05. But, the change in the mean IGA score was significant (p = 0.03). Further, the mycological cure was observed in 100% and 76.7% of participants in the test group and the control group respectively. On comparing inter-group the effects of the interventions on direct microscopy were found statistically significant (p = 0.034). In addition, no significant change in urinalysis, biochemical and haematological parameters from baseline to post-treatment in each group was observed. CONCLUSION: This study concluded that the test drugs (IHA and HK) were safe and effective in the treatment of PV. The oral (IHA) and local (HK) Unani formulations were tolerated well by all the participants The efficacy and safety of the IHA and HK were comparable to the standard drugs (Itraconazole and Terbinafine).


Subject(s)
Tinea Versicolor , Antifungal Agents/adverse effects , Child, Preschool , Humans , Immunoglobulin A , Infant , Itraconazole , Terbinafine/therapeutic use , Tinea Versicolor/drug therapy , Treatment Outcome
2.
Fitoterapia ; 153: 104974, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34166706

ABSTRACT

In Rwanda, the roots of Pentas longiflora Oliv. (Rubiaceae) have been used for a long time to treat Pityriasis versicolor. However, many people reported the use of leaves instead of roots. This research was conducted to compare the phytochemical composition and establish chromatographic methods for the standardization of roots and leaves extracts of P. longiflora. During this process, three new pentalongin glycosides (pentalonginoside A, pentalonginoside B, and pentalonginoside C) and two known glycosides of the same type (harounoside and clarinoside), as well as rutin, luteolin-7-rutinoside were isolated from methanol extract of leaves. In addition, pentalongin and psychorubrin, previously isolated from ethylacetate roots extract, were also identified in Pentas longiflora ethylacetate leaves extract. The presence of the antifungal compound pentalongin in leaves may explain the traditional use of leaves in the treatment of Pytiriasis versicolor. Furthermore, harounoside, psychorubrin, and pentalongin were selected as markers for HPLC fingerprints of MeOH extract. The accuracy and risk profile demonstrated the reliability of the validated method. In general, considerable variations of concentration in plant metabolites, including pentalongin, were observed between samples from different sites. The content in pentalongin (expressed as juglone) in collected samples ranged between 1.7 and 70.0 mg/100 g. The highest concentration (70.0 ± 17 mg/100 g) was registered in the cultivated samples from Mukoni. This important variation of pentalongin concentrations according to sampling sites, shows that in order to guarantee equivalent efficacy, finished products with P. longiflora should be standardized based on their pentalongin content.


Subject(s)
Plant Extracts/pharmacology , Rubiaceae/chemistry , Tinea Versicolor/drug therapy , Chromatography, High Pressure Liquid , Molecular Structure , Phytochemicals/isolation & purification , Phytochemicals/pharmacology , Plant Extracts/chemistry , Plant Extracts/standards , Plant Leaves/chemistry , Plant Roots/chemistry , Plants, Medicinal/chemistry , Rwanda , Tandem Mass Spectrometry
3.
Cell Tissue Bank ; 21(2): 313-320, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32162164

ABSTRACT

Pityriasis versicolor (PV) is a chronic skin disease caused by virulence activities of Malassezia, a genus of skin-associated yeasts. Traditionally, Tioconazole is used as a topical antifungal for curing PV. Previous investigations cited that human amniotic membrane (HAM), a placental tissue, has antimicrobial and anti-inflammatory activities and is useful as a dressing for healing skin lesions. Moreover, tea tree oil (TTO) has a potent antifungal efficacy. This clinical trial aims to achieve an alternative therapeutic treatment able to kill Malassezia and heal PV lesions using TTO-saturated HAM (TOSHAM), with little application times. This study subjected 120 patients with hypopigmented or hyperpigmented PV lesions; half patients were treated weekly with TOSHAM compared with the others who applying 1% Tioconazole cream daily as a traditional treatment. Microbiological evaluation of in vitro fungicidal activity of TOSHAM versus Tioconazole was carried out against Malassezia furfur culture. The clinical outcomes of this study proved the superior activity of TOSHAM to heal PV lesions than Tioconazole; this was in harmony with microbiological findings. This study approached a novel therapeutic treatment of PV with great outcomes by using TOSHAM.


Subject(s)
Amnion/radiation effects , Imidazoles/administration & dosage , Imidazoles/therapeutic use , Tea Tree Oil/therapeutic use , Tinea Versicolor/drug therapy , Administration, Topical , Adolescent , Adult , Child , Disease Progression , Female , Humans , Imidazoles/pharmacology , Malassezia/drug effects , Male , Microbial Sensitivity Tests , Pigmentation , Tea Tree Oil/pharmacology , Tinea Versicolor/microbiology , Treatment Outcome , Young Adult
4.
J Med Microbiol ; 67(2): 198-207, 2018 Feb.
Article in English | MEDLINE | ID: mdl-29388537

ABSTRACT

PURPOSE: The lack of novel antifungal drugs and the increasing incidence and severity of fungal infections are major concerns worldwide. Herein, we tested the activity of the Blad-containing oligomer (BCO), a new antifungal molecule already in use for agriculture, on Malassezia spp. and dermatophytes, the causal agents of human tinea versicolor and tinea pedis. Given the lack of a standard method for Malassezia susceptibility testing and the plethora of published methods, we also developed an improved method for this genus. METHODOLOGY: The efficacy of BCO was assessed in vitro and compared to that of the drugs currently utilized in the treatment of tinea versicolor (fluconazole and itraconazole) and tinea pedis (itraconazole and terbinafine). For dermatophytes, the standard microdilution broth-based method was used, with small adjustments, and several broth formulations and inocula sizes were tested to develop an improved susceptibility method for Malassezia spp. RESULTS: We successfully developed a microdilution broth-based method with considerable advantages over other available methods, and used it for all in vitro susceptibility tests of Malassezia spp. isolates. We report that, on a molar basis, BCO was more effective than fluconazole or itraconazole on most strains of Malassezia spp. isolated from clinical samples (n=29). By contrast, BCO was less effective than itraconazole or terbinafine on the common dermatophytes Trichophyton rubrum and Trichophyton interdigitale. CONCLUSION: These data place BCO as a promising drug for the treatment of Malassezia-associated skin diseases. Further in vivo studies are now required to ascertain its applicability in the clinical setting.


Subject(s)
Antifungal Agents/pharmacology , Arthrodermataceae/drug effects , Fungicides, Industrial/pharmacology , Malassezia/drug effects , Tinea Pedis/drug therapy , Tinea Versicolor/drug therapy , Antifungal Agents/therapeutic use , Crop Protection , Drug Discovery , Fluconazole/pharmacology , Fungicides, Industrial/therapeutic use , Humans , Itraconazole/pharmacology , Microbial Sensitivity Tests , Tinea Pedis/microbiology , Tinea Versicolor/microbiology , Trichophyton/drug effects
6.
An Bras Dermatol ; 88(3): 381-5, 2013.
Article in English | MEDLINE | ID: mdl-23793205

ABSTRACT

BACKGROUND: Pityriasis versicolor is a fungal infection caused by Malassezia spp. that has frequent relapses. OBJECTIVES: The main objective of this research was to perform phase I and II clinical studies, using formulations containing essential oil of Cymbopogon citratus in patients with pityriasis versicolor. METHODS: Phase I study included twenty volunteers to ascertain the safety of the formulations. In phase II, 47 volunteers randomly received essential oil formulations at 1.25 µL/mL concentration, for forty days. The shampoo should be applied three times a week and the cream twice a day. A control group in phase II, consisting of 29 volunteers, received the same formulations but with 2% ketoconazole as the active ingredient. RESULTS: No significant adverse events were observed in volunteers during Phase I. In Phase II, 30 (63.83%) volunteers using essential oil and 18 (62.07%) using ketoconazole remained until the end of the study. We observed a predominance of lesions in disseminated form, with M. sympodialis detected as the predominant agent identified in cultures. After 40 days of treatment, the rate of mycological cure was 60% (p <0.05) for the group treated with essential oil of C. citratus and over 80% (p <0.05) for the group treated with ketoconazole formulations. CONCLUSIONS: Notwithstanding the safety and antifungal effects observed in this study after application of formulations containing the essential oil of C. citratus, further studies with larger populations should be performed to confirm the actual potential of these formulations in the treatment of patients with Pityriasis versicolor.


Subject(s)
Antifungal Agents/therapeutic use , Cymbopogon/chemistry , Ketoconazole/therapeutic use , Oils, Volatile/administration & dosage , Phytotherapy , Tinea Versicolor/drug therapy , Adolescent , Adult , Aged , Female , Hair Preparations/therapeutic use , Humans , Malassezia , Male , Middle Aged , Pilot Projects , Plant Preparations/therapeutic use , Young Adult
7.
An. bras. dermatol ; 88(3): 381-385, jun. 2013. tab, graf
Article in English | LILACS | ID: lil-676236

ABSTRACT

BACKGROUND: Pityriasis versicolor is a fungal infection caused by Malassezia spp. that has frequent relapses. OBJECTIVES: The main objective of this research was to perform phase I and II clinical studies, using formulations containing essential oil of Cymbopogon citratus in patients with pityriasis versicolor. METHODS: Phase I study included twenty volunteers to ascertain the safety of the formulations. In phase II, 47 volunteers randomly received essential oil formulations at 1.25 μL/mL concentration, for forty days. The shampoo should be applied three times a week and the cream twice a day. A control group in phase II, consisting of 29 volunteers, received the same formulations but with 2% ketoconazole as the active ingredient. RESULTS: No significant adverse events were observed in volunteers during Phase I. In Phase II, 30 (63.83%) volunteers using essential oil and 18 (62.07%) using ketoconazole remained until the end of the study. We observed a predominance of lesions in disseminated form, with M. sympodialis detected as the predominant agent identified in cultures. After 40 days of treatment, the rate of mycological cure was 60% (p <0.05) for the group treated with essential oil of C. citratus and over 80% (p <0.05) for the group treated with ketoconazole formulations. CONCLUSIONS: Notwithstanding the safety and antifungal effects observed in this study after application of formulations containing the essential oil of C. citratus, further studies with larger populations should be performed to confirm the actual potential of these formulations in the treatment of patients with Pityriasis versicolor. .


FUNDAMENTOS: Pitiríase versicolor é uma micose causada pela Malassezia spp., e que apresenta frequentes recidivas. OBJETIVOS: Este trabalho objetivou realizar estudos clínicos de fase I e II, para essa patologia, com óleo essencial de Cymbopogon citratus. MÉTODOS: Na fase I, participaram vinte voluntários para averiguar a segurança das formulações. Na fase II, 47 voluntários receberam as formulações do óleo essencial a 1,25 μL/mL, as quais deveriam ser utilizadas por quarenta dias, sendo o xampu três vezes por semana e o creme duas vezes ao dia. Um grupo controle na fase II, constituído por 29 voluntários recebeu as mesmas formulações, com cetoconazol a 2%. RESULTADOS: Verificada a segurança das formulações com a finalização da fase I, onde nenhuma reação adversa significativa foi observada nos indivíduos sadios, conduziu-se a fase II. Nesta segunda fase, 30 (63,83%) voluntários utilizando óleo essencial e 18 (62,07%) cetoconazol permaneceram até o final do estudo. Observaram-se nos pacientes com pitiríase versicolor predomínio de lesões na forma disseminada e M. sympodialis foi o agente predominante identificado em cultura. Após 40 dias de tratamento, obteve-se um percentual de cura micológica de 60% (p < 0,05) para o grupo tratado com óleo essencial de C. citratus e superior a 80% (p < 0,05) para o grupo tratado com cetoconazol. CONCLUSÕES: Apesar da segurança e efeito antifúngico observados após aplicação das formulações contendo óleo essencial de C. citratus, outros estudos com maior número de portadores de pitiríase versicolor precisam ser realizados para confirmar o real potencial destas f...


Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Antifungal Agents/therapeutic use , Cymbopogon/chemistry , Ketoconazole/therapeutic use , Oils, Volatile/administration & dosage , Phytotherapy , Tinea Versicolor/drug therapy , Hair Preparations/therapeutic use , Malassezia , Pilot Projects , Plant Preparations/therapeutic use
8.
J Altern Complement Med ; 18(10): 978-82, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22871048

ABSTRACT

BACKGROUND: Pityriasis versicolor (PV) is a common superficial fungal infection of skin caused by the fungus, Malassezia furfur. It can occur at any age but occurs mainly during adolescence and typically presents with hypopigmented or hyperpigmented scaling plaques, generally on the trunk and upper arms. It often poses a therapeutic challenge. In the Unani system of medicine, many herbal drugs are used empirically for its treatment. OBJECTIVES: The objective of this study was to evaluate safety and efficacy of a topical Polyherbal Unani formulation in the management of PV on scientific parameters. DESIGN: This was a randomized, single-blind, standard controlled study. LOCATION: This study was performed in the Dermatology Outpatient Department, National Institute of Unani Medicine, Bangalore, India. SUBJECTS AND INTERVENTIONS: Forty-six (46) patients with PV were included in the study after taking informed consents and were randomly allocated to test and control groups. In the test group, a polyherbal formulation was advised for topical application while in the control group, sodium thiosulphate lotion (20%) was advised locally for a duration of 1 month. The assessment of the severity of PV and efficacy of treatment in both groups was carried out using the Total Sign and Symptom Score (TSSS) scale. Data were analyzed with the Instat Graph pad. RESULTS: The mean±standard error of the mean (SEM) scores of TSSS in the test group were 7.7±1.174 and 0.9±0.7881 before and after treatment, respectively, while it was 6.9±0.8756 and 1.2±0.7888 in the control group before and after treatment, respectively. Mean±SEM of TSSS of both groups was found to be significantly lowered (p<0.001) after treatment when compared with mean±SEM of TSSS before treatment. However, the polyherbal formulation showed precedence over the standard drug by exhibiting comparatively quicker response. Furthermore, no unpleasant side-effects were observed in the test group during and after the study. CONCLUSIONS: This study concluded that polyherbal Unani formulation is safe, effective, and superior to standard drug in the treatment of PV.


Subject(s)
Medicine, Unani , Phytotherapy , Plant Extracts/therapeutic use , Severity of Illness Index , Tinea Versicolor/drug therapy , Acetic Acid , Adolescent , Adult , Child , Female , Humans , Male , Middle Aged , Mustard Plant , Plant Extracts/adverse effects , Plumbaginaceae , Raphanus , Rubia , Single-Blind Method , Treatment Outcome , Young Adult
9.
J Dermatol ; 37(8): 699-702, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20649710

ABSTRACT

This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re-evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.


Subject(s)
Antifungal Agents/therapeutic use , Clotrimazole/therapeutic use , Fluconazole/therapeutic use , Tinea Versicolor/drug therapy , Adult , Clinical Protocols , Double-Blind Method , Female , Humans , Male , Recurrence , Treatment Outcome , Young Adult
10.
Int J Dermatol ; 46 Suppl 2: 23-8, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17958626

ABSTRACT

BACKGROUND: Superficial dermatomycoses are a common problem in tropical regions. Due to limited resources, specific antimycotic therapy is often not available. The present study was performed to assess the clinical efficacy of the antimicrobial agent Triclosan in bar soap in comparison with regular soap against selected superficial dermatomycoses in Tanzanian schoolchildren. METHODS: 820 primary school children were examined for skin disorders and 224 of these were included in the soap trial. The clinical presentation of dermatomycoses was recorded using a symptom score. Samples were taken for microscopic examination and mycological culture. The study participants received either bar soap containing Triclosan or a placebo for 2 months. They were re-examined at the end of this period. RESULTS: The benefit achieved by the addition of Triclosan was not statistically significant. Overall cure rates for Triclosan and placebo groups taken together were 21.8% for tinea versicolor, 58.3% for tinea capitis, 55.5% for tinea corporis and 68.8% for tinea pedis. This was confirmed microscopically. For the majority of the children the dermatomycoses improved significantly. CONCLUSIONS: The results strongly argue for regular soap use against common dermatomycoses as a low-cost and effective treatment. This promising finding should be considered in settings where dermatophyte infections represent a public health problem and where access to appropriate treatment and financial resources are limited.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Soaps/therapeutic use , Tinea Versicolor/drug therapy , Tinea/drug therapy , Triclosan/therapeutic use , Adolescent , Adult , Child , Female , Follow-Up Studies , Humans , Malassezia/isolation & purification , Male , Microbial Sensitivity Tests , Soaps/chemistry , Statistics, Nonparametric , Tanzania , Treatment Outcome , Trichophyton/isolation & purification
11.
Mycoses ; 50(3): 193-5, 2007 May.
Article in English | MEDLINE | ID: mdl-17472615

ABSTRACT

Flutrimazole is an imidazole derivative that has been proven to be efficient in superficial skin fungal infections. The aim of this randomised double-blind study was to compare for the first time, the efficiency and safety of flutrimazole 1% shampoo versus ketoconazole 2% shampoo in the treatment of tinea versicolor. Study population consisted of 60 patients with pityriasis versicolor diagnosed clinically and through direct microscopy and culture. Patients were randomly assigned to two groups: one instructed to apply flutrimazole shampoo 1% and one instructed to apply ketoconazole shampoo 2% both on head and body for 14 days. Patients were re-evaluated 14 days after the end of treatment clinically and through direct microscopy and culture. Twenty-one of 26 patients (80.8%) in the ketoconazole and 22 of 29 patients (75.9%) in the flutrimazole group had both visual healing and negative mycological evaluation. Comparison of the response between the two groups with the Yates' corrected chi-square was found statistically not significant (chi(2) = 0.19, d.f. = 1, P = 0.91). None of the patients in the two groups reported any adverse effects. Fourteen (53%) patients in the ketoconazole group and 23 (79%) in the flutrimazole group assessed the shampoos as cosmetically acceptable regarding texture, smell and foam properties. Flutrimazole shampoo 1% appears to present efficacy comparable with ketoconazole 2% in the treatment of tinea versicolor.


Subject(s)
Antifungal Agents , Clotrimazole/analogs & derivatives , Hair Preparations , Ketoconazole , Tinea Versicolor/drug therapy , Adult , Antifungal Agents/administration & dosage , Antifungal Agents/adverse effects , Antifungal Agents/therapeutic use , Clotrimazole/administration & dosage , Clotrimazole/adverse effects , Clotrimazole/therapeutic use , Double-Blind Method , Female , Humans , Ketoconazole/administration & dosage , Ketoconazole/adverse effects , Ketoconazole/therapeutic use , Malassezia/drug effects , Male , Tinea Versicolor/microbiology , Treatment Outcome
12.
Phytother Res ; 17(5): 555-7, 2003 May.
Article in English | MEDLINE | ID: mdl-12748998

ABSTRACT

In an open non-comparative study to evaluate the efficacy and safety of Acalypha wilkesiana ointment in superficial fungal skin diseases, 32 Nigerian patients with clinical and mycological evidence of superficial mycoses were recruited. Twelve patients defaulted and were lost to follow up, while one patient withdrew because of intolerable excoriation at the site of the lesion. Of the 19 patients that completed the trial, clinical cure was achieved in 73.3% of the patients. The ointment was very efficacious in the treatment of Tinea pedis, Pityriasis versicolor and Candida intetrigo where the cure rate was 100% in each condition. It is recommended that Acalypha ointment can be used for the treatment of these superficial mycoses.


Subject(s)
Dermatomycoses/drug therapy , Euphorbiaceae , Ointments/therapeutic use , Phytotherapy , Plant Extracts/therapeutic use , Candidiasis/drug therapy , Female , Humans , Kwashiorkor/drug therapy , Male , Nigeria , Plant Leaves/chemistry , Tinea Pedis/drug therapy , Tinea Versicolor/drug therapy , Treatment Outcome
13.
Med. cután. ibero-lat.-am ; 29(3): 154-157, mayo 2001. ilus, tab
Article in Es | IBECS | ID: ibc-3780

ABSTRACT

Las micosis cutáneas constituyen una patología relativamente frecuente en los pacientes sometidos a algún tipo de trasplante.Se presentan los resultados de un estudio realizado sobre la incidencia de pitiriasis versicolor en pacientes trasplantados renales en el Hospital La Paz, en un seguimiento llevado a cabo durante año y medio.Como principales características encontradas, destacamos elevada incidencia (58 por ciento), superior a la de otras series publicadas, tendencia a la afectación cutánea extensa, presencia de localizaciones atípicas, buena respuesta al tratamiento tópico convencional y ausencia de recidivas tras tratamiento profiláctico. (AU)


Subject(s)
Adolescent , Adult , Female , Male , Middle Aged , Humans , Tinea Versicolor/epidemiology , Kidney Transplantation/adverse effects , Tinea Versicolor/diagnosis , Tinea Versicolor/drug therapy , Incidence , Immunosuppressive Agents/administration & dosage , Follow-Up Studies , Clinical Diagnosis , Imidazoles/therapeutic use , Ketoconazole/therapeutic use
15.
Mycoses ; 38(9-10): 395-403, 1995.
Article in English | MEDLINE | ID: mdl-8569816

ABSTRACT

In a double-blind, randomized study the efficacy and tolerance of flutrimazole 1% solution were compared with bifonazole 1% solution, applied once daily for 4 weeks, in 40 patients with culturally proven dermatophytosis or cutaneous candidosis. Forty patients with mycologically proven pityriasis versicolor were treated with once-daily application for 1 week. The four groups of patients and distribution of target lesions were similar, although in the flutrimazole group more patients had cutaneous candidosis (n = 8 versus n = 1). The distribution of the sum of clinical scores was also similar in both groups. At the end of therapy the proportion of patients with negative microscopy and culture was 85% in the flutrimazole group and 65% in the bifonazole group. There was a significant difference (P = 0.022) in terms of efficacy, since 80% of patients in the flutrimazole group versus 40% in the bifonazole group were judged to have received effective treatment. At the assessment 6 weeks after the end of therapy the percentages of flutrimazole- and bifonazole-treated patients with negative mycology were 75% and 65% respectively. There were two relapses (one in each group), which represents a 5% rate. Fifteen flutrimazole-treated patients (75%) compared with 12-bifonazole-treated patients (60%) had overall effective therapy. Two patients treated with bifonazole (10%) and one treated with flutrimazole (5%) had a premature termination due to adverse events attributable to the medication. On assessment 3 weeks after the end of treatment, the patients with pityriasis versicolor were all clinically and mycologically healed with negative fluorescence, including the patients who withdrew from the full course of treatment (one in each group). Nine weeks after the end of therapy all the patients remained cured, with no relapses. The overall incidence of adverse events (mild local reactions such as irritation, burning and itching) was one and seven cases for bifonazole and flutrimazole respectively. One patient in each group had to abandon treatment owing to severe intolerance.


Subject(s)
Antifungal Agents/therapeutic use , Clotrimazole/analogs & derivatives , Dermatomycoses/drug therapy , Imidazoles/therapeutic use , Administration, Topical , Adolescent , Adult , Aged , Antifungal Agents/administration & dosage , Candidiasis, Cutaneous/drug therapy , Clotrimazole/administration & dosage , Clotrimazole/therapeutic use , Double-Blind Method , Female , Humans , Imidazoles/administration & dosage , Male , Middle Aged , Recurrence , Solutions , Tinea Versicolor/drug therapy
16.
Dermatology ; 190(4): 295-300, 1995.
Article in English | MEDLINE | ID: mdl-7655109

ABSTRACT

BACKGROUND: Flutrimazole is a new imidazole derivate. Its antifungal activity has been demonstrated in in vivo and in vitro studies to be comparable to that of clotrimazole and higher than bifonazole. AIM: To compare the efficacy and tolerability of flutrimazole cream 1% with a reference drug, bifonazole, in the treatment of dermatomycoses, eligible for topical treatment exclusively. METHODS: A multicentre, double-blind, randomized, parallel-group clinical trial was conducted. Patients with clinically and mycologically (KHO and/or culture) diagnosed fungal infection of the skin were included in this study and were randomized into two treatment groups: 1% flutrimazole or 1% bifonazole, applied to the affected area (target lesion) once a day. The principal criterion of efficacy, 'cure', was based on clinical and mycological assessment. RESULTS: Four hundred and forty-nine patients were included in the study (228 flutrimazole, 221 bifonazole). 'Intention-to-treat' analysis of the data showed a difference between the treatments in terms of the rate of cure (clinical and mycological) after 4 weeks: 73% in the flutrimazole group and 65% in the bifonazole group (p = 0.05). From a safety point of view, flutrimazole and bifonazole were well tolerated, and the overall incidence of adverse effects (mainly mild local effects like irritation or burning sensation) was 5%. CONCLUSIONS: One percent flutrimazole applied topically once a day in the treatment of fungal infections of the skin presents a better efficacy than bifonazole and a good tolerability.


Subject(s)
Antifungal Agents/administration & dosage , Clotrimazole/analogs & derivatives , Dermatomycoses/drug therapy , Imidazoles/administration & dosage , Administration, Topical , Adolescent , Adult , Aged , Antifungal Agents/therapeutic use , Candidiasis, Cutaneous/drug therapy , Chi-Square Distribution , Child , Clotrimazole/administration & dosage , Clotrimazole/therapeutic use , Dosage Forms , Double-Blind Method , Female , Humans , Imidazoles/therapeutic use , Male , Middle Aged , Spain , Tinea Versicolor/drug therapy
17.
Int J Dermatol ; 33(8): 588-92, 1994 Aug.
Article in English | MEDLINE | ID: mdl-7960360

ABSTRACT

BACKGROUND: Oral 8-methoxypsoralen is the drug of choice in photochemotherapy of several dermatoses, e.g., vitiligo and psoriasis. The aim of this trial is to produce a new preparation of the drug, which is able to overcome the difficulties met with the oral use of the older preparations. METHODS: A new preparation containing ultramicronized methoxypsoralen (8-MOP) in 10 mg capsules was tried in an open trial. The trial included 53 patients (15 psoriasis, 26 vitiligo, and 12 tinea versicolor). Light testing showed that the strongest erythema appeared 30 minutes after ingesting the capsules. Patients were exposed to UVA after that period. Laboratory studies were also performed using high performance liquid chromatography to assay the serum concentrations of the drug on normal individuals. RESULTS: Thirteen of the 15 psoriasis patients (87%) showed an excellent response (a remission) after 30 sittings. Twenty-two of the 26 vitiligo patients (85%) showed an excellent response (acceptable repigmentation) after 70 sittings. The 12 patients with tinea versicolor (100%) showed complete repigmentation after 12 sittings. The laboratory studies showed the optimum time to be between 35 to 55 minutes, verifying the clinical observation. CONCLUSIONS: The therapeutic effective dose was found to be 0.25 mg/kg. This new preparation of 8-MOP proved to be well tolerated by the patients, causing no epigastric discomfort, nausea, or vomiting, overcoming the biggest obstacle of oral 8-MOP therapy. It was also well tolerated by patients known to be sensitive to oral and/or topical 8-MOP therapy.


Subject(s)
Methoxsalen/administration & dosage , PUVA Therapy , Psoriasis/drug therapy , Tinea Versicolor/drug therapy , Vitiligo/drug therapy , Administration, Oral , Adolescent , Adult , Biological Availability , Capsules , Child , Dose-Response Relationship, Drug , Female , Humans , Male , Methoxsalen/pharmacokinetics , Methoxsalen/therapeutic use , Middle Aged , Pilot Projects , Treatment Outcome
18.
J Ethnopharmacol ; 42(1): 19-23, 1994 Mar.
Article in English | MEDLINE | ID: mdl-8046939

ABSTRACT

The therapeutic efficacy of Cassia alata leaf extract against Pityriasis versicolor has been reported for the first time involving humans. For the collection of clinically effective antifungal compounds from the leaves of Cassia alata, a simple procedure has been devised. A 10-year human study indicates that the leaf extract can be reliably used as a herbal medicine to treat Pityriasis versicolor. The leaf extract has no side-effects.


Subject(s)
Antifungal Agents/therapeutic use , Cassia/chemistry , Plant Extracts/therapeutic use , Plants, Medicinal , Tinea Versicolor/drug therapy , Adolescent , Adult , Female , Humans , Male , Middle Aged , Plant Extracts/isolation & purification
20.
Indian J Dermatol ; 34(3): 69-72, 1989 Sep.
Article in English | MEDLINE | ID: mdl-2632381

ABSTRACT

Two hundred cases of superficial mycosis (100 dermatophytosis, 40 candidiasis and 60 pityriasis versicolor) were studied for the comparative effect of miconazole and clotrimazole. The patients were evaluated both clinically and mycologically every 2 weeks for a period of 12 weeks. In dermatophytosis, miconazole showed accelerated response (75% cleared in 6 weeks) than clotrimazole (56%). In candidiasis, both were found to be effective (80-85%) cure though clotrimazole showed slightly earlier response (40% cure in 6 weeks) against miconazole (30% cure). In pityriasis versicolor both were, effective (miconazole 99.6% and clotrimazole 86.7%).


Subject(s)
Candidiasis, Cutaneous/drug therapy , Clotrimazole/therapeutic use , Dermatomycoses/drug therapy , Imidazoles/therapeutic use , Miconazole/therapeutic use , Tinea Versicolor/drug therapy , Humans , Nail Diseases/drug therapy , Time Factors
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