-
Corticosteroid transdermal delivery significantly improves arthritis pain and functional disability.Drug Delivery and Translational Research Feb 2017Arthritis is characterized by pain and functional limitation affecting the patients' quality of life. We performed a clinical study to investigate the efficacy of a...
Arthritis is characterized by pain and functional limitation affecting the patients' quality of life. We performed a clinical study to investigate the efficacy of a betamethasone valerate medicated plaster (Betesil) in improving pain and functional disability in patients with arthritis and osteoarthritis. We enrolled 104 patients affected by osteoarthritis (n = 40) or arthritis (n = 64) in different joints. Patients received diclofenac sodium cream (2 g, four times a day) or a 2.25-mg dose of Betesil applied to the painful joint every night before bedtime for 10 days. Pain and functional disability were assessed, by the Visual Analogue Scale (VAS) and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) scores. Redness was assessed by clinical inspection, and edema by the "fovea sign" method. C-reactive protein (CRP) was also measured; CRP can be used to cost-effectively monitor the pharmacological treatment efficacy and is increased during the acute-phase response, returning to physiological values after tissue recovery and functional restoration. All measurements were at baseline and at 10-day follow-up. At 10-day follow-up, a greater improvement in VAS and WOMAC pain and WOMAC stiffness and functional limitation scores from baseline was observed in patients treated with Betesil compared with diclofenac (all p < 0.01). At 10-day follow-up, improvement in redness, edema, and CRP levels from baseline was also greater in patients treated with Betesil compared with diclofenac (all p < 0.01). This study demonstrates the safety and efficacy of transdermal delivery of betamethasone valerate in patients affected by arthritis and osteoarthritis.
Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Arthritis; Betamethasone Valerate; C-Reactive Protein; Diclofenac; Drug Delivery Systems; Female; Glucocorticoids; Humans; Male; Middle Aged; Pain; Treatment Outcome
PubMed: 27928713
DOI: 10.1007/s13346-016-0340-9 -
The Journal of Dermatological Treatment 2016A ready to use betamethasone valerate 0.1% (BMV) dressing was effective and well-tolerated by patients receiving chronic plaque psoriasis treatment.
BACKGROUND
A ready to use betamethasone valerate 0.1% (BMV) dressing was effective and well-tolerated by patients receiving chronic plaque psoriasis treatment.
OBJECTIVE
Collect data related to BMV dressing used in the context of market authorization.
METHODS
An observational, prospective study, including 258 patients with a maximum 4-weeks-treatment of inflammatory dermatosis with BMV 2.25 mg plaster was performed. The prescription pattern was described and the disease severity assessed using a Physician Global Assessment (PGA). Patient satisfaction as well as their quality of life (DLQI) were evaluated. Clinical evaluation was performed before and after the treatment.
RESULTS
The DLQI scores improved from 10.0 ± 5.4 to 3.5 ± 3.5 points (p < 0.0001) and PGA decreased from 12.5 ± 3.1 to 4.2 ± 3.0 points (p < 0.0001). The highest DLQI and PGA improvement was reported for the eczema group. Subjects reported the test dressing was better than prior therapies with 93.5% very satisfied and 90.4% satisfied.
CONCLUSIONS
The BMV dressing is well-tolerated and effective in the treatment of inflammatory dermatoses, improving both the objective signs of the disease as well as patients' quality of life.
Topics: Adult; Aged; Bandages; Betamethasone Valerate; Female; Glucocorticoids; Humans; Male; Middle Aged; Patient Satisfaction; Prospective Studies; Psoriasis; Quality of Life
PubMed: 25898980
DOI: 10.3109/09546634.2015.1035692 -
Indian Journal of Cancer 2021Almost all the patients receiving curative radiotherapy for head and neck cancer develop radiation dermatitis, which many a times leads to treatment interruption and...
BACKGROUND
Almost all the patients receiving curative radiotherapy for head and neck cancer develop radiation dermatitis, which many a times leads to treatment interruption and reduce patient compliance. In this study, we evaluated the effect of potent topical steroid (Betamethasone Valerate 0.1%) cream on acute radiation dermatitis in head and neck cancer patients receiving curative radiotherapy.
METHODS
A total 106 patients of head and neck cancers were randomly divided into arm A (52 patients) and arm B (54 patients). The patient in study arm A were treated with topical betamethasone 0.1% twice daily during radiotherapy/chemo-radiotherapy and arm B was kept as control. The radiation reaction in both the groups was monitored weekly according to Radiation Therapy Oncology Group (RTOG) acute radiation dermatitis grading.
RESULTS
Out of 106 patients, 85 (80.2%) patients completed treatment. Patient in control arm had earlier onset of grade 1 reaction (5.7% in arm A vs 16.7 % in arm B at 2 week, P value 0.157 and 28.8% in arm A vs 50% in arm B at 3 week, P value 0.028) and progression of radiation dermatitis. In 7 week patient in arm A had higher grade 1 reaction (17.3% in arm A vs 0% in arm B), while arm B had higher grade 2 reaction (66.7% arm B vs 55.8% in arm A). There was no difference in incidence of grade 3 and 4 reaction. No difference was observed in time taken for reaction to heal.
CONCLUSION
Topical Betamethasone can delay the onset and progression of radiation dermatitis in head and neck cancer, without significant delay in wound healing.
Topics: Adrenal Cortex Hormones; Female; Head and Neck Neoplasms; Humans; Male; Middle Aged; Prospective Studies; Radiodermatitis
PubMed: 33402575
DOI: 10.4103/ijc.IJC_790_18 -
Indian Journal of Pharmacology 2021Nicolau syndrome is a rare serious drug reaction associated with the administering various injectable medications. It is often characterized by an acute and severe pain... (Review)
Review
Nicolau syndrome is a rare serious drug reaction associated with the administering various injectable medications. It is often characterized by an acute and severe pain accompanying erythema that tends to rapidly evolve into the livedoid reticular or hemorrhagic patches and less commonly to ulcers and skin necrosis. Herein, we report a 34-year-old woman who presented with painful, tender discoloration over her abdominal skin following subcutaneous glatiramer acetate injection. Since the patient was diagnosed with multiple sclerosis 18 months ago, she had been on treatment with subcutaneous glatiramer acetate injections thrice weekly. The patient was diagnosed with Nicolau syndrome clinically and histopathologically. After 15-day treatment with topical betamethasone valerate and mucopolysaccharide polysulfate cream twice daily, the lesion completely regressed with only minimal hypopigmented irregular scarring. Nicolau syndrome should be considered in patients with severe pain, tenderness, and redness localized at the injection site following glatiramer subacetate.
Topics: Adult; Antirheumatic Agents; Diagnosis, Differential; Female; Glatiramer Acetate; Humans; Injections, Subcutaneous; Multiple Sclerosis; Nicolau Syndrome
PubMed: 34975138
DOI: 10.4103/ijp.ijp_166_21 -
Se Pu = Chinese Journal of... May 2022A high throughput screening method based on ultra performance liquid chromatography-quadrupole-time-of-flight high resolution mass spectrometry (UPLC-Q-TOF HRMS) was...
[Fast screening and confirmation of 73 common prohibited compounds in cosmetics by ultra performance liquid chromatography-quadrupole-time-of-flight high resolution mass spectrometry].
A high throughput screening method based on ultra performance liquid chromatography-quadrupole-time-of-flight high resolution mass spectrometry (UPLC-Q-TOF HRMS) was developed for the simultaneous and rapid confirmation of 73 prohibited compounds in cosmetics. The sample was dispersed in a saturated sodium chloride solution and ultrasonically extracted using acetonitrile containing 0.2% (v/v) formic acid. The resultant solution was centrifuged and then cleaned using dispersive solid phase extraction using a primary secondary amine (PSA) sorbent. The purified solution was centrifuged, and the supernatant was filtered through a 0.22 μm membrane before determination. The optimal pretreatment method was determined by comparing the recovery rates obtained using different extraction solvents and different amounts of purifying agents. The chromatographic separation conditions and mass spectrometry scanning mode were also optimized. Chromatographic separation was performed on an Acquity UPLC HSS T3 column (100 mm×2.1 mm, 1.8 μm) with gradient elution using 0.1% (v/v) formic acid aqueous solution and methanol as mobile phases. The eluent from the column was further detected using Q-TOF HRMS with the high resolution multiple reaction monitoring (MRM HR) scanning mode. Retention time, precise mass of parent ion, isotope abundance ratio, and precise mass of fragment ions were the parameters considered for rapid untargeted screening and confirmation. The matrix effects of water- and cream-based cosmetics were investigated. The matrix effects could be addressed using the matrix matched standard curve method. The correlation coefficients for the 73 prohibited compounds were all >0.99 in the corresponding linear concentration range. The limits of detection (LODs) were in the range of 5-150 μg/kg, and the limits of quantification (LOQs) were in the range of 15-450 μg/kg. Average recoveries were in the range of 60.3%-130.3% at three spiked levels, and the intra-day and inter-day precisions were 0.8%-10.0% (=6) and 1.1%-15.0% (=3), respectively. A total of 692 cosmetics samples were screened; 16 positive samples were detected, namely, sulfamethoxazole, meprednisone, lincomycin, 4-acetamidophenol, trimethoprim, alfacalcidol, betamethasone 17-valerate, brimonidine, chloramphenicol, chlorpheniramine, clobetasol propionate, crotamiton, econazole, ketoconazole, prednisone 21-acetate, and prednisone, with content in the range of 0.5-1136.1 mg/kg. The optimized method is accurate, fast, and simple, and it is suitable for the routine detection and rapid screening of common prohibited compounds in cosmetics. In addition, a screening and confirmation library was established for the 650 prohibited compounds using SCIEX OS and Library View software, using information-dependent acquisition (IDA)-MS/MS mode for MS data acquisition. The database contains multiple types of information, including formulas, theoretical exact mass, retention time, precise mass of parent ion, isotope abundance ratio, and fragment ion distribution. The library can be used for the simultaneous and rapid confirmation of prohibited compounds in cosmetics.
Topics: Chromatography, High Pressure Liquid; Chromatography, Liquid; Cosmetics; Prednisone; Tandem Mass Spectrometry
PubMed: 35478002
DOI: 10.3724/SP.J.1123.2021.09010 -
Journal of Parasitic Diseases :... Sep 2015This case report presents a classical case of nodular scabies in a 12 year boy who complained of itching for 20-21 days before presentation to the hospital....
This case report presents a classical case of nodular scabies in a 12 year boy who complained of itching for 20-21 days before presentation to the hospital. Application of Betnovate ointment (Betamethasone valerate 0.1 %) before presentation to the hospital had provided only 2-3 days of relief from itching. Dermatological examination revealed skin colored to erythematous papule of 3-4 mm on the body with predilection for web space of fingers and flexural areas and nodules on the scrotum and groin. Based on this, clinical diagnosis of scabies with nodular scabies was made on the child. The scraping obtained from the web-space of the child showed mite under the light microscope, which confirms the diagnosis. Treatment with topical permethrin 5 % lotion resulted in 50-70 % subsidence of itching within a day, and improvement in impetigo lesions of his father in 5 days. However, the scrotal and groin nodular lesion of the child persisted with severe itching. Treatment with topical steroid and tacrolimus 0.1 % ointment did not show much improvement. Intralesional injection of triamcinolone (5 mg/ml) on the nodule resulted in 30-40 % subsidence in itching and 50-60 % reduction in the size of the lesion over 2-3 weeks.
PubMed: 26345076
DOI: 10.1007/s12639-013-0365-7 -
Drug Design, Development and Therapy 2013The use of transdermal therapeutic systems has spread worldwide since they allow effective local drug delivery. In the present study, we investigated the efficacy and... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND AND AIM
The use of transdermal therapeutic systems has spread worldwide since they allow effective local drug delivery. In the present study, we investigated the efficacy and safety of a new betamethasone valerate medicated plaster (Betesil®) to manage facial swelling, edema, inflammation, ecchymosis, and hematoma, when applied immediately after a facial rejuvenation procedure.
MATERIALS AND METHODS
We applied the plaster to the skin of 20 healthy patients for 12 hours immediately after hyaluronic acid-based procedure performed with the aim of erasing facial wrinkles of perioral and nasolabial folds and improving chin and eye contour. A further 20 patients underwent the same cosmetic procedure, but they were treated with an aescin 10% cream (applied immediately after the procedure, in the evening, and the morning after) and served as control group.
RESULTS
Betesil® application resulted in a significant improvement in swelling/edema/inflammation score, if compared with aescin 10% cream (P < 0.01). As for facial ecchymosis and hematoma around the needle injection track, only two patients in the active treatment group displayed minimal ecchymosis and hematoma. In the control group, two patients presented minimal ecchymosis and three slight hematoma. However, using the ecchymosis/hematoma score, no significant difference between Betesil® and aescin 10% cream groups was observed. Patients' satisfaction was significantly higher among subjects receiving Betesil®, if compared to patients receiving aescin 10% cream (P < 0.01).
CONCLUSION
The present study supports the use of Betesil® plaster immediately after facial cosmetic procedures in order to safely control swelling, edema, and inflammation.
Topics: Administration, Cutaneous; Adult; Aged; Betamethasone Valerate; Cosmetic Techniques; Edema; Escin; Female; Follow-Up Studies; Glucocorticoids; Humans; Hyaluronic Acid; Inflammation; Male; Middle Aged; Patient Satisfaction; Rejuvenation; Skin Aging; Treatment Outcome
PubMed: 24101860
DOI: 10.2147/DDDT.S45722 -
Cureus Jan 2023Acquired dermal macular hyperpigmentation (ADMH) is a term used to describe a group of diseases that are characterized by idiopathic macular dermal hypermelanosis. These...
Acquired dermal macular hyperpigmentation (ADMH) is a term used to describe a group of diseases that are characterized by idiopathic macular dermal hypermelanosis. These skin conditions include erythema dyschromicum perstans, lichen planus pigmentosus, and pigmented contact dermatitis, also known as Riehl's melanosis. This case report involves a 55-year-old woman who was generally healthy but who had been experiencing asymptomatic, slowly progressive skin lesions for the previous four years. A thorough inspection of her skin revealed many non-scaly, pin-point follicular brown macules, which in some spots had coalesced into patches across her neck, chest, upper extremities, and back. Darier disease and Dowling-Degos disease were included in the differential diagnosis. The biopsies of the skin revealed follicular plugging. The dermis had pigment incontinence with melanophages and slight perivascular and perifollicular mononuclear cell infiltrates. The patient was diagnosed with a follicular form of ADMH. Patient's skin condition caused her concern. She was reassured and prescribed topical steroids 0.1% betamethasone valerate ointment application twice a day for two days per week (weekends) and 0.1% tacrolimus ointment application twice a day for five days per week for three months. She showed some improvement and was put under periodic follow-ups.
PubMed: 36843742
DOI: 10.7759/cureus.34133 -
Magma (New York, N.Y.) Feb 2019To investigate if it was feasible to quantify the renal excretion of topically applied corticosteroids by F MRS.
OBJECTIVE
To investigate if it was feasible to quantify the renal excretion of topically applied corticosteroids by F MRS.
MATERIALS AND METHODS
Five participants, one healthy and four with skin diseases, were treated with ointment containing betamethasone 17-valerate. Urine samples were collected for up to 87 h after the initial application. A sample of ointment mixed with urine served as a study control. Organic fractions were obtained after sample freeze drying, and resolved in deuterated chloroform prior to acquisition of F MR spectra at 470 MHz for typically 8 h.
RESULTS
We detected fluorine signals in 40 of the 62 fractions of organic extracts. The corticosteroid was detected in samples from all patients, ranging from 0.1 to 2.8% of the applied steroid. No fluorine signal was obtained in samples from the healthy volunteer.
DISCUSSION
F MRS can be utilized to detect topically applied corticosteroids in urine. However, more work is required to optimize and control for extraction procedures, complete spectral assignments and reliable quantification.
Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Aged; Betamethasone Valerate; Chloroform; Dermatitis, Contact; Female; Fluorine-19 Magnetic Resonance Imaging; Healthy Volunteers; Humans; Magnetic Resonance Spectroscopy; Male; Middle Aged; Ointments; Pilot Projects; Pruritus; Psoriasis; Skin; Skin Diseases; Urinalysis
PubMed: 30610404
DOI: 10.1007/s10334-018-00734-y -
Muscles, Ligaments and Tendons Journal 2016to investigate the efficacy and safety of a medicated plaster containing betamethasone valerate (BMV) 2.25 mg in patients with chronic elbow tendinopathy.
OBJECTIVE
to investigate the efficacy and safety of a medicated plaster containing betamethasone valerate (BMV) 2.25 mg in patients with chronic elbow tendinopathy.
METHODS
randomized, double-blind, placebo-controlled study with assignment 2:2:1:1 to BMV medicated plaster applied daily for 12 hours, daily for 24 hours or matched placebo. 62 patients aged ≥18 years with chronic lateral elbow tendinopathy were randomized. The primary efficacy variable was pain reduction (VAS) at day 28. Secondary objectives included summed pain intensity differences (SPID), overall treatment efficacy and tolerability.
RESULTS
mean reduction in VAS pain score at day 28 was greater in both BMV medicated plaster groups, -39.35±27.69 mm for BMV12-h and -36.91±32.50 mm for BMV24-h, than with placebo, -20.20±27.32 mm. Considering the adjusted mean decreases, there was a statistically significant difference between BMV12-h and placebo (p=0.0110). Global pain relief (SPID) and overall treatment efficacy were significantly better with BMV. BMV and placebo plasters had similar local tolerability and there were few treatment-related adverse events.
CONCLUSIONS
BMV plaster was significantly more effective than placebo at reducing pain in patients with chronic elbow tendinopathies. The BMV plaster was safe and well tolerated.
PubMed: 27331041
DOI: 10.11138/mltj/2016.6.1.131