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British Medical Journal Jul 1971The efficacy of betamethasone 17-valerate (5 mg) and prednisolone 21-phosphate (20 mg) retention enemata in the outpatient treatment of distal proctocolitis was compared... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
The efficacy of betamethasone 17-valerate (5 mg) and prednisolone 21-phosphate (20 mg) retention enemata in the outpatient treatment of distal proctocolitis was compared in a formal clinical trial. The two treatments were equally effective in inducing remissions of the disease, but the betamethasone valerate enema produced less adrenal suppression.
Topics: Adolescent; Adrenal Glands; Adult; Aged; Betamethasone; Colitis, Ulcerative; Depression, Chemical; Enema; Female; Humans; Hydrocortisone; Intestinal Absorption; Male; Middle Aged; Prednisolone; Proctitis; Remission, Spontaneous
PubMed: 5090826
DOI: No ID Found -
European Journal of Pharmaceutics and... Feb 2009The objective was to compare the in vivo distribution profiles of betamethasone 17-valerate (BMV) across the stratum corneum (SC) following (a) delivery from gelled and... (Clinical Trial)
Clinical Trial
The objective was to compare the in vivo distribution profiles of betamethasone 17-valerate (BMV) across the stratum corneum (SC) following (a) delivery from gelled and un-gelled formulations, and (b) two different skin cleaning procedures at the end of the application period. BMV was dissolved in gelled and un-gelled vehicles comprising either medium chain triglycerides (MCT) or a brand microemulsion (ME). The BMV concentration was adjusted to 80% of saturation and applied to the forearms of healthy volunteers. After 2 h, the treated skin site was cleaned either with a dry paper towel or with an isopropyl alcohol swab, and the SC was then progressively removed by repeated adhesive tape-stripping. BMV distribution profiles across the SC showed reasonable reproducibility, and that delivery from the ME was significantly superior to that from MCT. Gelled vehicles were less efficiently removed from the skin surface by dry wiping than un-gelled formulations. Removing excess formulation more aggressively with isopropyl alcohol resulted in a lower apparent uptake of drug into the SC. Excess gelled formulation may be trapped in the skin 'furrows', and requires an efficient skin cleaning procedure to ensure its complete removal.
Topics: 2-Propanol; Administration, Cutaneous; Adult; Betamethasone Valerate; Biological Availability; Emulsions; Female; Gels; Glucocorticoids; Humans; Male; Reproducibility of Results; Skin; Skin Absorption; Tissue Distribution; Triglycerides; Young Adult
PubMed: 18940255
DOI: 10.1016/j.ejpb.2008.10.001 -
Drug Delivery and Translational Research Apr 2022Predicting the dermal bioavailability of topically delivered drugs is challenging. In this work, minimally invasive stratum corneum (SC) sampling was used to quantify...
Predicting the dermal bioavailability of topically delivered drugs is challenging. In this work, minimally invasive stratum corneum (SC) sampling was used to quantify the delivery of betamethasone valerate (BMV) into the viable skin. Betnovate® cream (0.1% w/w BMV) was applied at three doses (2, 5, and 10 mg cm) to the ventral forearms of 12 healthy volunteers. The mass of drug in the SC was measured using a validated tape-stripping method (a) after a 4-h "uptake" period, and (b) following a 6-h "clearance" period subsequent to cream removal. Concomitantly, the skin blanching responses to the same doses were assessed with a chromameter over 22 h post-application. BMV uptake into the SC was significantly higher for the 5 mg cm dose compared to those of 2 and 10 mg cm. In all cases, ~30% of the drug in the SC at the end of the uptake period was cleared in the subsequent 6 h. From the SC sampling data, the average drug flux into the viable epidermis and its first-order elimination rate constant from the SC were estimated as 4 ng cm h and 0.07 h, respectively. In contrast, skin blanching results were highly variable and insensitive to the dose of cream applied. The SC sampling method was able to detect a 50% difference between two applied doses with 80% power; detection of a 20% difference would require a larger sample size. SC sampling enabled quantitative metrics describing corticosteroid delivery to the viable epidermis to be determined.
Topics: Betamethasone Valerate; Epidermis; Glucocorticoids; Humans; Skin; Skin Absorption
PubMed: 34599470
DOI: 10.1007/s13346-021-01064-8 -
Carbohydrate Polymers Jun 2018Mucoadhesive membranes were proposed in this study as drug delivery system for betamethasone-17-valerate (BMV) in the treatment of recurrent aphthous stomatitis (RAS)....
Mucoadhesive membranes were proposed in this study as drug delivery system for betamethasone-17-valerate (BMV) in the treatment of recurrent aphthous stomatitis (RAS). The membranes were obtained by using the polymers chitosan (CHI) in both presence and absence of polyvinilpyrrolidone (PVP), following the solvent evaporation method. The presence of PVP in the membranes causes significant modifications in its thermal properties. Changes in the thermal events at 114 and 193 °C (related to BMV melting point), and losses in mass (39.38 and 30.68% for CH:PVP and CH:PVP-B, respectively), suggests the incorporation of BMV in these membranes. However, the morphological aspects of the membranes do not change after adding PVP and BMV. PVP causes changes in swelling ratios (>80%) of the membranes, and it is suggested that the reorganization of the polymer mesh was highlighted by the chemical interactions between the polymers leading to different percentages of BMV released ∼40% and ∼80% from CH-B and CH:PVP-B. BMV release profile follows Korsmeyer and Peppas model (n > 0.89) which suggests that the diffusion of the drug in the swollen matrix is driven by polymer relaxation. In addition, the membranes containing PVP (higher swelling ability) present high rates of tensile strength, and therefore, higher mucoadhesion. Moreover, given the results presented, the developed mucoadhesive membranes are a promising system to deliver BMV for the treatment of RAS.
PubMed: 29628256
DOI: 10.1016/j.carbpol.2018.02.079 -
Journal of Clinical Medicine Sep 2023Umbilical granuloma (UG) is a common problem during the neonatal period; however, its epidemiology and etiology are poorly studied, and the best treatment option has not...
Umbilical granuloma (UG) is a common problem during the neonatal period; however, its epidemiology and etiology are poorly studied, and the best treatment option has not yet been established. We examined the medical records of neonates who were born and underwent 1-month evaluations at our hospital between 2013 and 2022 to investigate the frequency of-and factors associated with-UG, as well as the annual trends of UG treatments and their efficacy. Of the 6680 eligible neonates, 395 (5.9%) had UG. The annual incidence rate ranged from 3.8% to 7.3%. Gestational age, birth weight, and incidence of meconium-stained amniotic fluid were significantly associated with UG. Silver nitrate cauterization was the predominant UG treatment from 2013 to 2016. Silver nitrate cauterization and topical betamethasone valerate were nearly equally applied in 2017. Betamethasone application became predominant in 2018. The healing rates during the initial treatment period were 91% for silver nitrate cauterization, 97.7% for betamethasone application, 60% for ethanol disinfection, and 88% for ligation; these rates were significantly different ( < 0.001). Topical steroid application may be the most effective treatment. If steroid application is ineffective, then silver nitrate cauterization and ligation may be important treatment options.
PubMed: 37763044
DOI: 10.3390/jcm12186104 -
Skin Pharmacology and Physiology 2022Proactive therapy with topical corticosteroids (TCSs) is the standard treatment for chronic inflammatory diseases such as atopic dermatitis; however, skin atrophy as TCS... (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of Intermittent Treatment with Topical Corticosteroids and Calcineurin Inhibitors on Epidermal and Dermal Thickness Using Optical Coherence Tomography and Ultrasound.
INTRODUCTION
Proactive therapy with topical corticosteroids (TCSs) is the standard treatment for chronic inflammatory diseases such as atopic dermatitis; however, skin atrophy as TCS side effect remains a concern.
METHODS
This 16-week, evaluator-blinded, within-patient placebo-controlled, randomized study enrolled volunteers with healthy skin conditions. For 12 weeks, their volar forearm and the back of their hand were applied with hydrocortisone acetate 1% cream (HC), methylprednisolone aceponate 0.1% cream (MPA), betamethasone valerate 0.1% cream (BMV), or an active agent-free base cream (Dermatop® Basiscreme) once daily twice weekly, and pimecrolimus 1% cream (PIM) twice daily twice weekly. Epidermal and dermal thickness was measured by optical coherence tomography and high-frequency ultrasound, respectively. Furthermore, skin atrophy and telangiectasia were determined by contact dermatoscopic photography (Dermaphot®).
RESULTS
After 8 and 12 weeks, only BMV led to significant epidermal thinning on both sites. Four weeks after the end of treatment, epidermal thickness returned to baseline. No dermal thinning, atrophy, or telangiectasia was observed.
CONCLUSIONS
MPA, HC, and PIM may be more suitable for repeated and prolonged treatment, especially in chronic diseases.
Topics: Administration, Topical; Calcineurin Inhibitors; Dermatitis, Atopic; Dermatologic Agents; Glucocorticoids; Humans; Tomography, Optical Coherence; Treatment Outcome
PubMed: 34348352
DOI: 10.1159/000518214 -
Potential combination topical therapy of anal fissure: development, evaluation, and clinical study†.Drug Delivery Nov 2018To treat anal fissure, internal anal sphincterotomy may be associated with surgical risks and incidence of incontinence. Botulinum toxin injection into the anal... (Randomized Controlled Trial)
Randomized Controlled Trial
To treat anal fissure, internal anal sphincterotomy may be associated with surgical risks and incidence of incontinence. Botulinum toxin injection into the anal sphincter is invasive and expensive. Headache and hypotension hindered topical treatment with glyceryl trinitrate. Greater patient compliance, potentiated efficacy, reduced side effects, and lower cost are the major advantages offered by the combination therapy. Therefore, combination topical gels of nifedipine (NIF), lidocaine hydrochloride (LDH) and betamethasone valerate (BMV) were prepared and evaluated regarding viscosity, pH, drug content, and in vitro release. Compatibility study of drug-drug and drug-excipient mixtures preceded the formulation. Stability study was performed. A prospective randomized clinical trial was conducted for six weeks to assess the efficacy of the optimized formula in the treatment of anal fissure either acute (AAF, 37 patients) or chronic (CAF, 34 patients) in comparison with three single drug market products. The compatibility was indicated except in case of LDH with each of poloxamer 407 (P407), methylparaben, and propylparaben as well as BMV with P407. The gels showed acceptable viscosity ranges, tolerated pH values, and drugs content limits complying with the pharmacopeial limit. The gel containing 10% Transcutol (F2) was selected as optimized formula due to the significant (p < 0.05) enhancement in NIF release. The recommended storage temperature was 8 °C. In comparison with the market products, the optimized gel can be represented as a potential combination therapy of acute and chronic anal fissures as suggested by significantly increased healing% and significantly reduced pain, bleeding, anal discharge and itching without side effects.
Topics: Administration, Topical; Adult; Aged; Anesthetics, Local; Anti-Inflammatory Agents, Non-Steroidal; Betamethasone; Drug Combinations; Drug Compounding; Drug Therapy, Combination; Excipients; Female; Fissure in Ano; Gels; Humans; Lidocaine; Male; Middle Aged; Nifedipine; Prospective Studies; Vasodilator Agents; Young Adult
PubMed: 30430875
DOI: 10.1080/10717544.2018.1507059 -
BMJ (Clinical Research Ed.) Mar 2005To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Electronic searches of the Cochrane Library, Medline, and Embase.
STUDY SELECTION
Randomised controlled trials of topical pimecrolimus or tacrolimus reporting efficacy outcomes or tolerability.
EFFICACY
investigators' global assessment of response; patients' global assessment of response; proportions of patients with flares of atopic dermatitis; and improvements in quality of life. Tolerability: overall rates of withdrawal; withdrawal due to adverse events; and proportions of patients with burning of the skin and skin infections.
DATA SYNTHESIS
4186 of 6897 participants in 25 randomised controlled trials received pimecrolimus or tacrolimus. Both drugs were significantly more effective than a vehicle control. Tacrolimus 0.1% was as effective as potent topical corticosteroids at three weeks and more effective than combined treatment with hydrocortisone butyrate 0.1% (potent used on trunk) plus hydrocortisone acetate 1% (weak used on face) at 12 weeks (number needed to treat (NNT) = 6). Tacrolimus 0.1% was also more effective than hydrocortisone acetate 1% (NNT = 4). In comparison, tacrolimus 0.03% was more effective than hydrocortisone acetate 1% (NNT = 5) but less effective than hydrocortisone butyrate 0.1% (NNT = -8). Direct comparisons of tacrolimus 0.03% and tacrolimus 0.1% consistently favoured the higher strength formulation, but efficacy differed significantly between the two strengths only after 12 weeks' treatment (rate ratio 0.80, 95% confidence interval 0.65 to 0.99). Pimecrolimus was far less effective than betamethasone valerate 0.1% (NNT = -3 at three weeks). Pimecrolimus and tacrolimus caused significantly more skin burning than topical corticosteroids. Rates of skin infections in any of the comparisons did not differ.
CONCLUSIONS
Both topical pimecrolimus and topical tacrolimus are more effective than placebo treatments for atopic dermatitis, but in the absence of studies that show long term safety gains, any advantage over topical corticosteroids is unclear. Topical tacrolimus is similar to potent topical corticosteroids and may have a place for long term use in patients with resistant atopic dermatitis on sites where side effects from topical corticosteroids might develop quickly. In the absence of key comparisons with mild corticosteroids, the clinical need for topical pimecrolimus is unclear. The usefulness of either treatment in patients who have failed to respond adequately to topical corticosteroids is also unclear.
Topics: Administration, Topical; Adult; Child; Dermatitis, Atopic; Dermatologic Agents; Humans; Ointments; Patient Compliance; Quality of Life; Randomized Controlled Trials as Topic; Tacrolimus; Treatment Outcome
PubMed: 15731121
DOI: 10.1136/bmj.38376.439653.D3 -
Indian Journal of Dermatology Mar 2013To evaluate the efficacy and safety of fixed drug combination (FDC) halometasone 0.05% and fusidic acid 2% (group A) vs FDC betamethasone 0.12% and neomycin sulfate 0.5%...
Evaluation of Efficacy, Safety, and Tolerability of Fixed Dose Combination (FDC) of Halometasone 0.05% and Fusidic Acid 2% W/W Topical Cream Versus FDC of Betamethasone Valerate 0.12% and Neomycin Sulphate 0.5% W/W Topical Cream in the Treatment of Infected Eczematous Dermatosis in Indian Subjects:...
AIM
To evaluate the efficacy and safety of fixed drug combination (FDC) halometasone 0.05% and fusidic acid 2% (group A) vs FDC betamethasone 0.12% and neomycin sulfate 0.5% cream (group B) in acute or chronic infected eczematous dermatosis, through a randomized open-label, comparative, multicentric study.
MATERIALS AND METHODS
A total of 152 patients were randomized to either Group A or Group B. EASI (Eczema Area and Severity Index), IGA (Investigator's global assessment), scale for severity of eczema, pruritus, and safety parameters were assessed at baseline, Day 5/Day 10, Day 10/20, and Day 20/Day 30 for acute/chronic cases. Skin swabs were tested at screening, Day 10, and end of the study.
RESULTS
Staphylococcus aureus was the frequently encountered causative agent. There was a significant reduction within the study groups in EASI, IGA scales for severity of eczema, pruritus at various visits, compared to baseline. At the end of study, 83.87% in group A and 65.71% in group B were culture negative. Cure rate was 54.28% and 50% in group A and B, respectively. Five adverse events were reported in five patients, of which three patients withdrew from the study.
CONCLUSION
Halometasone 0.05% and Fusidic acid 2% cream is effective, safe, well tolerated with comparable efficacy to the comparator in the treatment of acute and chronic infected eczematous dermatosis.
PubMed: 23716800
DOI: 10.4103/0019-5154.108041