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British Dental Journal Sep 2021
Topics: Betamethasone; Betamethasone Valerate
PubMed: 34561568
DOI: 10.1038/s41415-021-3487-9 -
International Journal of Radiation... Jan 2021We assessed the role of topical betamethasone as a prophylactic agent in patients receiving radiation for head and neck malignancies. (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
We assessed the role of topical betamethasone as a prophylactic agent in patients receiving radiation for head and neck malignancies.
METHODS AND MATERIALS
This randomized, open-label, phase 3 trial was completed at a single research institute. Patients receiving curative radiation for head and neck cancer were randomized into 2 groups of 75 patients each by computer-generated permuted block random assignment. Patients in the test arm applied 0.1% topical betamethasone valerate cream once a day, after radiation. Patients in the control arm received best supportive care. The Radiation Therapy Oncology Group acute toxicity grading scale was used to assess radiation dermatitis after every fifth fraction until completion and at 2 weeks after treatment. Primary outcome in both arms was the proportion of patients who developed grade 2 and 3 acute skin reaction. The trial is registered at the Central Trial Registry of India (CTRI/2017/04/008298).
RESULTS
Between April 15, 2017, and October 30, 2018,150 patients were randomized into the study, with 75 patients in each arm. Fourteen patients in the test arm and 15 patients in the control arm did not complete the intended treatment. Per the intention-to-treat analysis, 25 of 75 patients (33.3%) and 38 of 75 patients (50.7%) developed grade 2 or greater radiation dermatitis in the test and control arms, respectively (absolute difference, 17.4%; 95% confidence interval, 4%-30%; P = .032). Fifteen of 75 patients (20%) developed grade 3 reactions in the test arm compared with 18 of 75 patients (24%) in the control arm (absolute difference, 4%; 95% confidence interval, 7%-15%; P = .554).
CONCLUSION
Although prophylactic use of betamethasone significantly reduced the composite outcome of the proportion of patients developing grade 2 and grade 3 radiation dermatitis, it did not reduce the proportion of patients developing the clinically significant outcome of grade 3 radiation dermatitis.
Topics: Acute Disease; Administration, Topical; Adult; Aged; Aged, 80 and over; Betamethasone Valerate; Female; Head and Neck Neoplasms; Humans; Male; Middle Aged; Radiodermatitis
PubMed: 32853709
DOI: 10.1016/j.ijrobp.2020.08.040 -
BMJ Open Jan 2022This is a randomised, multi-centre, open-label, phase II study to evaluate the efficacy of betamethasone valerate ointment on radiation-induced oral mucositis in...
Preventive effects of betamethasone valerate ointment for radiation-induced severe oral mucositis in patients with oral or oropharyngeal cancer: protocol for a multicentre, phase II, randomised controlled trial (Bet-ROM study).
INTRODUCTION
This is a randomised, multi-centre, open-label, phase II study to evaluate the efficacy of betamethasone valerate ointment on radiation-induced oral mucositis in patients with head and neck cancer undergoing concomitant radiotherapy with cisplatin or cetuximab.
METHODS AND ANALYSIS
The trial will take place at seven hospitals in Japan. Patients will be randomised (1:1) into betamethasone and control groups after the occurrence of grade 1 oral mucositis. In the betamethasone group, patients will use betamethasone valerate ointment five times a day, in addition to usual oral hygiene guidance. The primary endpoint is the incidence and onset time of grade 3 oral mucositis. The secondary endpoints are the incidence and onset time of grade 2 oral mucositis, incidence and onset time of oral candidiasis, completion of radiation therapy and adverse events. Target accrual is 102 patients with a two-sided type I error rate of 5% and 80% power to detect an 80% risk reduction in the incidence of grade 3 oral mucositis.
ETHICS AND DISSEMINATION
This study was approved by the Clinical Research Review Board of Nagasaki University (No. CRB20-009). All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publication. The datasets generated during the study will be available from the corresponding author on reasonable request.
TRIAL REGISTRATION NUMBER
jRCTs071200013.
Topics: Betamethasone Valerate; Clinical Trials, Phase II as Topic; Head and Neck Neoplasms; Humans; Multicenter Studies as Topic; Ointments; Oropharyngeal Neoplasms; Radiation Injuries; Randomized Controlled Trials as Topic; Stomatitis
PubMed: 35039301
DOI: 10.1136/bmjopen-2021-056781 -
Archives of Dermatological Research Apr 2023Alopecia areata (AA) is a non-scarring tissue-specific autoimmune disorder. Many therapeutic modalities are available for the treatment of AA, but none has yet proven to...
Alopecia areata (AA) is a non-scarring tissue-specific autoimmune disorder. Many therapeutic modalities are available for the treatment of AA, but none has yet proven to be uniformly effective. Fractional carbon dioxide (FRCO) laser has been introduced as a treatment modality for AA. The objective is to evaluate and compare the efficacy and safety of FRCO laser in treatment of AA alone or in combination with betamethasone valerate cream. 30 patients were assigned to one of the following groups, Group A FRCO, Group B FRCO plus betamethasone valerate cream or Group C (betamethasone valerate cream). Patients received eight laser sessions 2 weeks apart, treatment period was 4 months. A statistically significant decrease in SALT score, dystrophic hair and a statistically significant increase in terminal hair was observed in all groups. Patient satisfaction level and reduction in SALT score were significantly higher among FRCO and FRCO plus betamethasone valerate group. However, no statistical significant difference was found between FRCO group and FRCO combined with betamethasone valerate cream group. FRCO laser is a safe and effective treatment modality for AA when used alone or in combination with betamethasone valerate cream. However, it was found superior to betamethasone valerate cream monotherapy.
Topics: Humans; Betamethasone Valerate; Alopecia Areata; Carbon Dioxide; Lasers, Gas; Treatment Outcome; Betamethasone
PubMed: 36114868
DOI: 10.1007/s00403-022-02393-5 -
The Journal of Allergy and Clinical... May 1976The value of betamethasone valerate by inhalation in the prophylactic therapy of severe childhood asthma has been established. To determine whether the efficacy of this... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
The value of betamethasone valerate by inhalation in the prophylactic therapy of severe childhood asthma has been established. To determine whether the efficacy of this drug is due to a local or a systemic action a double-blind crossover study of 28 days' treatment with oral betamethasone valerate and 28 days' treatment with inhaled steroid was carried out in 10 asthmatic children. Daily doses used were 1 mg orally and 800 mug by inhalation. Nine patients had fewer symptoms, higher peak expiratory flow rates, and a lower bronchodilator requirement on inhaled than on oral therapy. Exercise-induced bronchoconstriction was diminished on inhaled therapy. Five children requested early termination of the oral therapy period because of unacceptable symptoms. Nine parents stated a preference for the period of inhaled therapy. It is concluded that betamethasone valerate is highly effective by inhalation but that a comparable oral dose has no appreciable clinical effect.
Topics: Administration, Intranasal; Administration, Oral; Asthma; Betamethasone; Betamethasone Valerate; Child; Clinical Trials as Topic; Female; Humans; Male; Peak Expiratory Flow Rate
PubMed: 770551
DOI: 10.1016/0091-6749(76)90053-1 -
BMJ Clinical Evidence Dec 2010Seborrhoeic dermatitis affects at least 10% of the population. Malassezia (Pityrosporum) ovale is thought to be the causative organism, and causes inflammation by still... (Review)
Review
INTRODUCTION
Seborrhoeic dermatitis affects at least 10% of the population. Malassezia (Pityrosporum) ovale is thought to be the causative organism, and causes inflammation by still poorly defined mechanisms. Seborrhoeic dermatitis tends to relapse after treatment.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of topical treatments for seborrhoeic dermatitis of the scalp in adults? What are the effects of topical treatments for seborrhoeic dermatitis of the face and body in adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 12 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: bifonazole, emollients, ketoconazole, lithium succinate, selenium sulphide, tar shampoo, terbinafine, and topical corticosteroids (betamethasone valerate, clobetasol propionate, clobetasone butyrate, hydrocortisone, mometasone furoate).
Topics: Antifungal Agents; Betamethasone Valerate; Dermatitis, Seborrheic; Emollients; Hair Preparations; Humans; Hydrocortisone; Severity of Illness Index; United States Food and Drug Administration
PubMed: 21418692
DOI: No ID Found -
The British Journal of Dermatology Dec 1978In the albino rat, topical betamethasone 17-valerate acts as an anticorticosteroid. This steroid is inactive in a dermal atrophy assay over a dose range where...
In the albino rat, topical betamethasone 17-valerate acts as an anticorticosteroid. This steroid is inactive in a dermal atrophy assay over a dose range where betamethasone and hydrocortisone display atrophogenic activity. At appropriate concentrations betamethasone 17-valerate competitively inhibits the atrophogenic effects of both betamethasone and triamcinolone acetonide. Since betamethasone and betamethasone 17-valerate penetrate rat skin in vivo at essentially the same rate, it is concluded that the latter compound is relatively resistant to hydrolysis during penetration, and that it binds to rat corticosteroid receptor proteins in such a manner as to prevent expression of corticosteroid activity. Therefore, the rat cannot be used as a model species to predict activity in man for this compound.
Topics: Administration, Topical; Adrenal Cortex Hormones; Animals; Atrophy; Betamethasone; Betamethasone Valerate; Dose-Response Relationship, Drug; Male; Rats; Skin; Triamcinolone Acetonide
PubMed: 737128
DOI: 10.1111/j.1365-2133.1978.tb07060.x -
Postgraduate Medical Journal Jun 1977A double-blind, cross-over study was undertaken to compare inhalation of betamethasone valerate (BV, 800 microgram daily) with sodium cromoglycate (SCG, 80 mg daily) in... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
A double-blind, cross-over study was undertaken to compare inhalation of betamethasone valerate (BV, 800 microgram daily) with sodium cromoglycate (SCG, 80 mg daily) in twenty children requiring bronchodilators for perennial asthma. Each treatment period lasted 4 weeks but statistical comparisons were made only in respect of the last 14 days of each therapy. When the children were using BV they required not only less of the bronchodilator drugs but had fewer symptoms and higher daily peak expiratory flow rates when taking SCG. Statistically, all these differences were highly significant. For 2 weeks before the main trial each child was given a placebo aerosol (single-blind) to assess severity of asthma. In comparison with this period, SCG was associated with a significantly increased peak expiratory flow rate a lower symptom score by day but not by night, but their usage of bronchodilators followed a similar pattern. When the BV period was compared with the placebo period, patients had an even more significant rise in peak expiratory flow rate, less day and night symptoms, and took hardly any bronchodilators. The response to the two drugs did seem to depend upon which was given first. No monilial infections were found, nor any measurable defect in adrenal response from either treatment. Betamethasone valerate is considered to be superior to sodium cromoglycate as a treatment for childhood asthma insufficiently controlled on bronchodilators.
Topics: Adolescent; Asthma; Betamethasone; Betamethasone Valerate; Child; Clinical Trials as Topic; Cromolyn Sodium; Drug Therapy, Combination; Humans; Peak Expiratory Flow Rate; Placebos
PubMed: 407559
DOI: 10.1136/pgmj.53.620.315 -
Journal of Pharmaceutical Sciences Dec 1995Simultaneous diffusion and metabolism of betamethasone 17-valerate was studied using betamethasone 17-valerate, betamethasone 21-valerate, and betamethasone as...
Simultaneous diffusion and metabolism of betamethasone 17-valerate was studied using betamethasone 17-valerate, betamethasone 21-valerate, and betamethasone as permeants. These corticosteroids were suspended in silicone adhesive and applied to an artificial living skin equivalent (LSE) for 72 h. When betamethasone was applied, no metabolites were detected in the receptor medium. Conversely, with betamethasone 21-valerate application, only betamethasone but no betamethasone 21-valerate was detected in the receptor medium indicating the metabolism of the latter by skin esterases. When tested with the theory for simultaneous diffusion and metabolism, the result is consistent with the enzyme rate constant in the LSE homogenate measured in a previous study. When betamethasone 17-valerate was applied to the LSE, more than half of the total amount of corticosteroids detected in the receptor medium was unchanged, consistent with the previously reported chemical (as opposed to enzymatic) degradation half-life of about 8 h. This result also indicated that very little metabolism of betamethasone 17-valerate occurred in the skin.
Topics: Betamethasone; Betamethasone Valerate; Cells, Cultured; Humans; Skin; Skin Absorption
PubMed: 8748331
DOI: 10.1002/jps.2600841215 -
The British Journal of Dermatology Jun 1977Betamethasone valerate aerosol, given in doses of up to 800 microgram per day, was compared with placebo in a double-blind trial involving 23 patients with oral lichen... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
Betamethasone valerate aerosol, given in doses of up to 800 microgram per day, was compared with placebo in a double-blind trial involving 23 patients with oral lichen planus. The majority of patients receiving the active aerosol noted improvement within the first 2 weeks of treatment and at 8 weeks the lesions had almost cleared; in contrast, only 2 patients on placebo showed slight improvement over the same time period. The results suggest that this form of treatment is an effective and acceptable method of controlling the discomfort due to oral lichen planus, especially where minor erosions are present.
Topics: Adult; Aerosols; Aged; Betamethasone; Betamethasone Valerate; Clinical Trials as Topic; Female; Humans; Lichen Planus; Male; Middle Aged; Mouth Diseases
PubMed: 326295
DOI: 10.1111/j.1365-2133.1977.tb05211.x