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At least 19 recordsLinked to original sources
PubMed1999

Topical corticosteroids in association with miconazole and chlorhexidine in the long-term management of atrophic-erosive oral lichen planus: a placebo-controlled and comparative study between clobetasol and fluocinonide.

OBJECTIVE: To evaluate the efficacy of a combination of topical corticosteroids with topical antimycotic drugs in the therapy of atrophic-erosive forms of oral lichen planus (OLP). PATIENTS AND METHODS: The study population consisted of 60 patients with OLP subdivided into three groups matched for sex and age. The first group (25 patients) and the second group (24 patients) received respectively 0.05% clobetasol propionate ointment or 0.05% fluocinonide ointment in an adhesive medium (4% hydroxyethyl cellulose gel) plus in each case antimycotic treatment consisting of miconazole gel and 0.12% chlorhexidine mouthwashes. The third group (11 patients), placebo group, received only hydroxyethyl cellulose gel and antimycotic treatment as above. All the treatment regimens were carried out for 6 months. Each patient was examined every 2 months during the 6-month period of active treatment and for a further 6 months of follow-up. Objective and subjective clinical progress was scored and compared between the three groups. Plasma cortisol levels were monitored in half the patients using the topical corticosteroids. RESULTS: All patients treated with clobetasol and 90% of the patients treated with fluocinonide witnessed some improvement, whereas in the placebo group only 20% of patients improved (P < 0.0001 and P = 0.00029, respectively. However, when considering complete responses, only clobetasol gave significantly better results than placebo. Clobetasol resolved 75% of the lesions whereas fluocinonide was effective in 25% of cases and placebo in none. Clobetasol achieved better results statistically than did fluocinonide (P = 0.00442) and placebo (P = 0.00049) whereas there was no statistical difference among fluocinonide and placebo (P = 0.140). Similar results were obtained for symptoms. Both drugs were shown to be effective in the treatment of erosive lesions, but clobetasol was considerably more efficacious than fluocinonide in the atrophic areas (75% vs 25% of total response, respectively) (P = 0.00442). None of the treated patients contracted oropharyngeal candidiasis. After 6 months of follow-up, 65% of the clobetasol-treated group and 55% of the fluocinonide group were stable. Estimation of plasma cortisol levels showed no significant systemic adverse effects of clobetasol or fluocinonide. CONCLUSIONS: Our results suggest that a very potent topical corticosteroid such as clobetasol may control OLP in most cases, with no significant adrenal suppression or adverse effects. Moreover, a concomitant antimycotic treatment with miconazole gel and chlorhexidine mouthwashes is a useful and safe prophylaxis against oropharyngeal candidiasis.

Administration, Topical↗
PubMedDate not supplied

Mometasone furoate 0.1%-salicylic acid 5% ointment twice daily versus fluocinonide 0.05% ointment twice daily in the management of patients with psoriasis.

This study compared the clinical efficacy and safety of the combination agent mometasone furoate 0.1%-salicylic acid 5% ointment with those of the single agent fluocinonide 0.05% ointment, each applied twice daily for 21 days, in the treatment of patients with moderate to severe plaque psoriasis. Forty adult patients were included in this single-center, randomized, double-masked, intraindividual, bilateral-paired comparative trial. Two similar, bilaterally symmetrical target lesions on the trunk, arms, or legs of each patient were selected for treatment and evaluation. One lesion was treated with mometasone furoate 0.1%-salicylic acid 5% ointment, and the other was treated with fluocinonide 0.05% ointment, both twice daily for 21 days. Treatment was randomly assigned to the right or left side of the body. Signs of psoriasis (ie, erythema, induration, and scaling) and overall clinical response were evaluated and scored on days 4, 8, 15, and 22 and compared against baseline. Patients were asked to evaluate the treatments for efficacy and acceptability at each visit. The primary efficacy parameter was the mean percentage of improvement in total sign scores for the target lesions. Safety was evaluated based on clinical observation and patients' reports. Beginning with day 15, statistically significant differences favoring mometasone furoate 0.1%-salicylic acid 5% ointment over fluocinonide 0.05% ointment were seen in individual and total sign scores, as well as in overall global clinical response. On day 15, 20 patients expressed a preference for one treatment over the other, and 20 patients made no distinction between the two. Of those who expressed a preference, significantly more patients believed mometasone furoate 0.1%-salicylic acid 5% ointment to be better than fluocinonide 0.05% ointment. On day 22, of 25 patients who expressed a preference, significantly more patients thought mometasone furoate 0.1%-salicylic acid 5% ointment was better than fluocinonide 0.05% ointment. No adverse events were recorded for either treatment group. The combination mometasone furoate 0.1%-salicylic acid 5% ointment was significantly more efficacious than and equally as safe as fluocinonide 0.05% ointment in the management of patients with plaque psoriasis and was preferred by a greater number of patients.

Adolescent↗
PubMed1994

Comparative study of calcipotriene (MC 903) ointment and fluocinonide ointment in the treatment of psoriasis.

BACKGROUND: The topical vitamin D analogue calcipotriene has been reported to be an effective treatment for patients with psoriasis. Comparative studies with topical steroids are informative in judging this new therapy. OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of calcipotriene ointment 0.005% versus fluocinonide ointment 0.05% in the treatment of plaque psoriasis. METHODS: This study was a randomized, double-blind, parallel-group, active-controlled trial in adults who had at least mild overall disease severity and plaque elevation of at least moderate severity. Treatments were applied twice daily for 6 weeks, and subjects were evaluated at weeks 0, 2, 4, and 6. Subjects were graded on a 9-point scale (0 to 8) for scaling, erythema, plaque elevation, and for overall disease severity. A physician's global assessment of improvement/worsening was performed at every visit. RESULTS: A total of 114 subjects were enrolled at six study sites. Ninety-nine subjects completed the trial. Mean scores for signs of scaling and plaque elevation in calcipotriene-treated subjects were significantly lower by week 2 than in the fluocinonide-treated subjects. These scores continued to be significantly lower than fluocinonide through week 6 (p < 0.05). Mean scores for erythema in calcipotriene-treated subjects were significantly lower than those in fluocinonide-treated subjects at weeks 4 and 6 (p < 0.05). Both the physician's global assessment and overall disease severity showed statistically significant treatment differences in favor of calcipotriene at week 4 (p < 0.05). This superior efficacy continued through week 6. Treatment-related adverse events were observed in 12 calcipotriene-treated subjects and 5 fluocinonide-treated subjects; all were considered minor. CONCLUSION: Calcipotriene was superior to fluocinonide in the treatment of plaque psoriasis.

Adult↗
PubMed1995

Chemical stability of fluocinolone acetonide ointment and fluocinonide cream diluted in emollient bases.

The chemical stability of fluocinolone acetonide ointment and fluocinonide cream was studied when diluted in emollient bases. Fluocinolone acetonide ointment was diluted 1 in 4 with Unguentum Merck and Lipobase. Fluocinonide cream was also studied in these bases, with the addition of Metosyn Diluent, at dilutions of 1 in 4 and 1 in 10. Regression analysis gave the time for 5% degradation of fluocinolone acetonide at a dilution of 1 in 4 in Unguentum Merck and in Lipobase as 12 weeks in both cases. The lower 95% confidence bound of each regression line was used to set shelf lives, for additional safety, and gave values of 1 month for the Unguentum Merck dilution and 2 months for the Lipobase dilution. Fluocinonide dilutions were more stable than the corresponding fluocinolone acetonide dilutions, with no degradation detectable during the study. The base made no observable difference to stability. Shelf lives, based on the lower 95% confidence bound of the regression data, of more than 6 months would be feasible for all of the fluocinonide 1 in 4 dilutions studied and for the 1 in 10 dilution in Unguentum Merck. However, for fluocinonide 1 in 10 in Metosyn Diluent, a shelf life of only 6 weeks could be assured, due to there being more variation in the analytical results. There were insufficient data to determine a storage life based on the lower 95% confidence bound of the regression for fluocinonide 1 in 10 in Lipobase. More data would be required to determine if there was significant interbatch variation in the stability of the dilutions.

Administration, Topical↗
PubMed1985

Clobetasol propionate versus fluocinonide creams in psoriasis and eczema.

A double-blind, parallel comparison was made of the short-term efficacy and safety of three times daily regimens of 0.05% clobetasol propionate cream and 0.05% fluocinonide cream in 114 adolescent and adult patients with psoriasis and 113 with eczema. After 2 weeks of topical applications, patients were assessed according to (1) investigators' overall judgment of clinical response, (2) degree of severity of specific signs and symptoms, and (3) patients' evaluation of improvement. In all three response categories in psoriasis, and in two of three in eczema, clobetasol was statistically significantly superior to fluocinonide (p less than 0.05-p less than 0.001). Healing commenced more rapidly with clobetasol and there was no indication of tachyphylaxis. In contrast, the healing rate with fluocinonide slowed noticeably after the first week, and there was a greater tendency to relapse following fluocinonide treatment. Both regimens were safe: drug-related side effects were generally mild and occurred most commonly with fluocinonide therapy in eczema patients. Overall, drug-related effects occurred in 4% of patients receiving clobetasol and 12% receiving fluocinonide (p less than 0.05). Transient morning plasma cortisol reductions below 5 micrograms/dl occurred in 6% of clobetasol-treated patients, reverting to normal within 1 week of the end of treatment.

Administration, Topical↗
PubMed2006

An open-label adrenal suppression study of 0.1% fluocinonide cream in pediatric patients with atopic dermatitis.

OBJECTIVE: To assess the potential of a superhigh-potency 0.1% fluocinonide cream to suppress the hypothalamic-pituitary-adrenal (HPA) axis in pediatric patients with atopic dermatitis. DESIGN: A multicenter, multiple-dose, open-label safety study in 4 age cohorts with 0.1% fluocinonide cream applied once or twice daily for 2 weeks. SETTING: Clinical outpatient setting. PATIENTS: Patients with moderate to severe atopic dermatitis with 20% or more of the body surface area involved were included in the study. Each cohort began only after evaluation of the preceding cohort: ages 12 to younger than 18 years (cohort 1); 6 to younger than 12 years (cohort 2); 2 to younger than 6 years (cohort 3); and 3 months to younger than 2 years (cohort 4). MAIN OUTCOME MEASURES: Assessment of HPA axis suppression, local and systemic adverse events, and change in disease status from baseline. RESULTS: Suppression of the HPA axis was not observed in any patient treated once daily for the 2 youngest cohorts. Suppression was observed in 1 (7%) of 15 and 2 (12%) of 16 patients in the fluocinonide twice-daily group in cohorts 1 and 2, respectively. In all 4 cohorts, more than 90% of patients in the fluocinonide once-daily and twice-daily groups showed improvement in their disease status. CONCLUSIONS: Once-daily treatment with 0.1% fluocinonide cream for 2 weeks does not result in HPA axis suppression under the conditions of this study. Once-daily applications provided similar or better efficacy as twice-daily applications with a lower risk of HPA axis suppression. The frequency of HPA axis suppression is no greater in younger children than in older children. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN71227633.

Adolescent↗
PubMed1998

Once-daily tazarotene gel versus twice-daily fluocinonide cream in the treatment of plaque psoriasis.

BACKGROUND: A new class of topical receptor-selective acetylenic retinoids, the first of which is tazarotene, has been developed. OBJECTIVE: Our purpose was to compare the safety, efficacy, and duration of therapeutic effect of 12 weeks of once-daily tazarotene 0.1% and 0.05% gel with that of twice-daily fluocinonide 0.05% cream in the treatment of patients with plaque psoriasis. METHODS: Three hundred forty-eight patients with plaque psoriasis were enrolled and 275 patients completed a multicenter, investigator-masked, randomized, parallel-group clinical trial. RESULTS: Both tazarotene gels were as effective as fluocinonide in reducing plaque elevation after 1 week of treatment, and tazarotene 0.1% gel was similar to fluocinonide in reducing scaling of trunk/limb lesions at all study weeks except week 4. Tazarotene 0. 1% gel was similar to fluocinonide in reducing scaling of knee/elbow lesions at weeks 8 and 12. Fluocinonide had a significantly greater effect on erythema than tazarotene at weeks 2 through 8. However, treatments were not significantly different at week 12, and tazarotene demonstrated significantly better maintenance of therapeutic effect after cessation of therapy. CONCLUSION: Tazarotene 0.1% and 0.05% gels were safe and effective in the treatment of mild-to-moderate plaque psoriasis.

Administration, Cutaneous↗
PubMed1999

[Fluocinonide Reference Standard (Control 981) of National Institute of Health Sciences].

The raw material of fluocinonide was examined for preparation of the "Fluocinonide Reference Standard (Control 981)". The analytical data obtained were: UV spectrum, lambda max of 237.4 nm; IR spectrum, same as that of the Fluocinonide Reference Standard (Control 841); optical rotation, [alpha]20(D) = + 84.4 degree, thin-layer chromatography, one impurity detected; high-performance liquid chromatography, three impurities detected and total amount estimated to be about 0.20%; loss on drying, 0.15%; assay by HPLC, 99.6% Based on the above results, the raw material was authorized as the Fluocinonide Reference Standard (Control 981) of the National Institute of Health Sciences.

Fluocinonide↗
PubMedDate not supplied

Comparative efficacy of halcinonide and fluocinonide creams in psoriasis and eszematous dermatoses.

The clinical efficacy of halcinonide and fluocinonide creams was compared in the treatment of 392 patients with corticosteroid-responsive dermatoses, including psoriasis, and various eczematous dermatoses such as atopic dermatitis, eczematous dermatitis, and neurodermatitis. The severity of the condition treated was moderate or severe in most of the patients. Usually, the creams were applied three times daily for two to three weeks. In psoriasis, halcinonide was superior to fluocinonide (P less than 0.05). There was no significant difference between halcinonide and fluocinonide in the treatment of the eczematous dermatoses. Both creams were well tolerated, each being associated with local side effects (such as burning sensation, dryness, erythema, and pruritus) in 4.9 per cent of patients.

Administration, Topical↗
PubMed1982

The effect of topical fluocinonide ointment on phototherapy of psoriasis.

The effect of fluocinonide ointment and 5% crude coal tar on clearance of plaque-type psoriasis vulgaris by phototherapy was studied in 25 hospitalized patients using the bilateral comparison technique. All treated areas received ultraviolet radiation from Westinghouse fluorescent FS-40 bulbs (290-400 nm) in doses calculated to produce a minimal delayed erythema. The topically applied compounds (fluocinonide ointment, 5% Crude coal tar, white petrolatum) were applied individually or in combination. In nearly all comparisons clearance of psoriatic plaques was obtained after the same number of ultraviolet exposures, although many (8 or 14) of the areas treated with fluocinonide ointment had an accelerated early response. It thus appears that although the use of topical corticosteroids may enhance the early therapeutic response of psoriatic plaques it does not hasten the clearance of these plaques.

Adult↗
PubMedDate not supplied

A trial with fluocinonide in recalcitrant dermatoses.

The effectiveness and safety of fluocinonide 0.05% in a cream base (FAPG cream: fatty acid propylene glycol) were evaluated in 105 patients with recalcitrant corticosteroid-responsive dermatoses that had failed to respond adequately to at least two weeks' previous treatment with one of 21 other topical corticosteroid preparations. At the end of the three weeks, 66 (71.0%) of the 93 patients who qualified for analysis showed excellent to moderate improvement with fluocinonide. Side effects were rare and of a minor nature. The general effectiveness of fluocinonide is indicated in this single-blind trail in which excellent or moderate results predominated in 8 of the 12 different diagnosis.

Drug Evaluation↗
PubMed1979

Multicenter trial of fluocinonide in an emollient cream base.

Working independently, eight investigators evaluated the clinical effectiveness of fluocinonide 0.05% in a three-week double-blind paired comparison trial of 240 patients. Half the investigators compared fluocinonide emollient cream with betamethasone valerate 0.1% cream in the treatment of atopic dermatitis, while the remaining four compared the study drug with triamcinolone acetonide 0.1% cream in the treatment of psoriasis. Statistical analysis showed clinical responses favored fluocinonide p = 0.021 (Wilcoxon Signed Rank) for the atopic dermatitis group and p = 0.001 (Wilcoxon Signed Rank) for the psoriasis group.

Adolescent↗
PubMed1982

Treatment of psoriasis with amcinonide 0.1 percent and fluocinonide 0.05 percent ointments. A comparative double-blind study.

Fifty psoriatic patients enrolled in a three week, double-blind, randomized, parallel study were treated either with amcinonide ointment 0.1 percent twice a day or fluocinonide ointment 0.05 percent three times a day. After Week 1 of treatment, no statistically significant differences appeared between the two groups with regard to improvement in signs and symptoms of psoriasis. After Week 3, improvement in all efficacy parameters, except erythema, and in Total Scores in both groups was greater than 50 percent as compared to baseline evaluations. There were no statistically significant differences between the treatment groups. Only one patient in each group reported an adverse experience that could have been drug-related. Amcinonide ointment used twice a day and fluocinonide ointment used three times a day were judged comparable with regard to safety and clinical efficacy. Amcinonide may be considered to have some advantage over fluocinonide because its twice a day treatment schedule makes it more convenient for patients to use.

Administration, Topical↗
PubMed1976

Clinical comparison of desonide cream with fluocinonide cream in steroid-responsive dermatologic disorders.

Desonide, a nonfluorinated topical corticosteriod, was compared with fluocinonide, a potent fluorinated steroid, in identical concentrations, in the treatment of various steroid-responsive dermatologic disorders. In treatment comparisons, the group treated with desonide showed significantly (p less than 0.05) better erythema and scaling scores after the first week than did those in the fluocinonide group, but the two week scores were not significantly different. Although 5 percent of patients treated with fluocinonide had adverse reactions, no such reactions were observed in the desonide-treated group.

Adolescent↗
PubMed1993

Fluocinonide in an adhesive base for treatment of oral lichen planus. A double-blind, placebo-controlled clinical study.

Patients with symptomatic oral lichen planus frequently require therapy to reduce signs and symptoms. For this purpose, corticosteroids are often applied topically. In a randomized, double-blind, placebo-controlled study, the efficacy of the topical application of 0.025% fluocinonide was evaluated. Forty consecutive patients with oral lichen planus diagnosed on the basis of histopathologic and immunofluorescence findings participated in this study. All patients were followed for 3 to 17 months. No adverse effects were noted during follow-up period. In the group of 20 patients that received the drug, 4 patients (20%) showed a complete remission, and 12 patients (60%) had a good or partial response to topical treatment. In the placebo-group, these figures were 0 and 6 (30%), respectively. The majority of the placebo-group (70%) did not respond at all with regard to signs (Xt2 = 10.4; p = 0.0013) and symptoms (Xt2 = 6.97, p = 0.008). The results from this study suggest that topical application of fluocinonide in an adhesive base is a safe and effective drug to reduce signs and symptoms in oral lichen planus.

Adolescent↗
PubMed1994

Double-blind clinical trial of 0.05% clobetasol propionate (corrected from proprionate) ointment in orabase and 0.05% fluocinonide ointment in orabase in the treatment of patients with oral vesiculoerosive diseases.

Because of their chronic nature treatment of oral vesiculoerosive diseases remains a challenge to the oral medicine specialist. Even though oral vesiculoerosive diseases respond well to systemic steroids, adverse side effects sometimes limit their use. Potent topical steroids are becoming increasingly useful to treat these chronic conditions with good control. The purpose of this double-blind clinical trial was to compare clobetasol propionate and fluocinonide ointment in orabase as treatments for controlling oral vesiculoerosive diseases. Sixty patients were asked to participate (43 women and 17 men). Data are reported for 55 patients. Each patient was seen at baseline and at days 7, 14, 21, and 28. Variables evaluated were pain, erythema, atrophy, and size of lesion. Overall, both medications had a beneficial effect in the control of symptoms and signs of oral vesiculoerosive diseases with minimal side effects. Clobetasol propionate was better than fluocinonide as measured by more rapid control of pain (within 7 days). Candidiasis was observed in 13 patients at the end of treatment (most of them carriers of Candida). Therefore normal carriers should be identified and treatment with antifungal therapy instituted before the patient begins using topical steroids.

Aged↗
PubMed1999

Effect of concentration and degree of saturation of topical fluocinonide formulations on in vitro membrane transport and in vivo availability on human skin.

PURPOSE: The thermodynamic activity of drugs in topical vehicles is considered to significantly influence topical delivery. In vitro diffusion across a synthetic membrane was shown to be correlated to the degree of saturation of the drug in the applied vehicle and therefore offers a potential for increased topical drug delivery. Fluocinonide a topical corticosteroid, was chosen as a model compound to investigate in vitro and in vivo availability from formulations with different degrees of saturation. METHODS: Sub-, as well as, supersaturated drug solutions were prepared using PVP as an antinucleant agent. In vitro membrane diffusion experiments across silicone membrane and in vivo pharmacodynamic activity assessments, using the human skin blanching assay, were carried out. RESULTS: Over the concentration range studied, the in vitro membrane transport of fluocinonide was proportional to the degree of saturation of the respective formulations. The in vivo pharmacodynamic response in the human skin blanching assay was related to the concentration of the drug in the vehicle irrespective of the degree of saturation. CONCLUSIONS: From the membrane permeation experiment it can be concluded, that the drug flux might be increased supra-proportionally with increasing donor concentration, drug (super-)saturation (proportional), beyond what would be anticipated based on ideal donor concentration and partition coefficient considerations only. These findings could not be confirmed in the in vivo investigation, probably due to additional vehicle effects (e.g., enhancement, irritation, drug binding) which have to be expected and could have altered the integrity of the stratum corneum and therewith topical bioavailability of the drug.

Administration, Topical↗
PubMedDate not supplied

Comparison of 0.25% desoxymethasone ointment with 0.05% fluocinonide ointment in psoriasis.

A double-blind comparative trial was carried out in 56 patients with psoriasis to assess the effectiveness of 0.25% desoxymethasone and 0.05% fluocinonide ointments. All patients showed marked improvement in their condition with twice daily application of the ointments during the 2-week period of the trial. Erythema, scaling and induration on the desoxymethasone-treated side showed a significantly better improvement than on the fluocinonide-treated side.

Adolescent↗