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Health Technology Assessment... Oct 2023Emollients are recommended for children with eczema (atopic eczema/dermatitis). A lack of head-to-head comparisons of the effectiveness and acceptability of the... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Emollients are recommended for children with eczema (atopic eczema/dermatitis). A lack of head-to-head comparisons of the effectiveness and acceptability of the different types of emollients has resulted in a 'trial and error' approach to prescribing.
OBJECTIVE
To compare the effectiveness and acceptability of four commonly used types of emollients for the treatment of childhood eczema.
DESIGN
Four group, parallel, individually randomised, superiority randomised clinical trials with a nested qualitative study, completed in 2021. A purposeful sample of parents/children was interviewed at ≈ 4 and ≈ 16 weeks.
SETTING
Primary care (78 general practitioner surgeries) in England.
PARTICIPANTS
Children aged between 6 months and 12 years with eczema, of at least mild severity, and with no known sensitivity to the study emollients or their constituents.
INTERVENTIONS
Study emollients sharing the same characteristics in the four types of lotion, cream, gel or ointment, alongside usual care, and allocated using a web-based randomisation system. Participants were unmasked and the researcher assessing the Eczema Area Severity Index scores was masked.
MAIN OUTCOME MEASURES
The primary outcome was Patient-Oriented Eczema Measure scores over 16 weeks. The secondary outcomes were Patient-Oriented Eczema Measure scores over 52 weeks, Eczema Area Severity Index score at 16 weeks, quality of life (Atopic Dermatitis Quality of Life, Child Health Utility-9 Dimensions and EuroQol-5 Dimensions, five-level version, scores), Dermatitis Family Impact and satisfaction levels at 16 weeks.
RESULTS
A total of 550 children were randomised to receive lotion (analysed for primary outcome 131/allocated 137), cream (137/140), gel (130/135) or ointment (126/138). At baseline, 86.0% of participants were white and 46.4% were female. The median (interquartile range) age was 4 (2-8) years and the median Patient-Oriented Eczema Measure score was 9.3 (SD 5.5). There was no evidence of a difference in mean Patient-Oriented Eczema Measure scores over the first 16 weeks between emollient types (global = 0.765): adjusted Patient-Oriented Eczema Measure pairwise differences - cream-lotion 0.42 (95% confidence interval -0.48 to 1.32), gel-lotion 0.17 (95% confidence interval -0.75 to 1.09), ointment-lotion -0.01 (95% confidence interval -0.93 to 0.91), gel-cream -0.25 (95% confidence interval -1.15 to 0.65), ointment-cream -0.43 (95% confidence interval -1.34 to 0.48) and ointment-gel -0.18 (95% confidence interval -1.11 to 0.75). There was no effect modification by parent expectation, age, disease severity or the application of UK diagnostic criteria, and no differences between groups in any of the secondary outcomes. Median weekly use of allocated emollient, non-allocated emollient and topical corticosteroids was similar across groups. Overall satisfaction was highest for lotions and gels. There was no difference in the number of adverse reactions and there were no significant adverse events. In the nested qualitative study ( = 44 parents, = 25 children), opinions about the acceptability of creams and ointments varied most, yet problems with all types were reported. Effectiveness may be favoured over acceptability. Parents preferred pumps and bottles over tubs and reported improved knowledge about, and use of, emollients as a result of taking part in the trial.
LIMITATIONS
Parents and clinicians were unmasked to allocation. The findings may not apply to non-study emollients of the same type or to children from more ethnically diverse backgrounds.
CONCLUSIONS
The four emollient types were equally effective. Satisfaction with the same emollient types varies, with different parents/children favouring different ones. Users need to be able to choose from a range of emollient types to find one that suits them.
FUTURE WORK
Future work could focus on how best to support shared decision-making of different emollient types and evaluations of other paraffin-based, non-paraffin and 'novel' emollients.
TRIAL REGISTRATION
This trial is registered as ISRCTN84540529 and EudraCT 2017-000688-34.
FUNDING
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (HTA 15/130/07) and will be published in full in ; Vol. 27, No. 19. See the NIHR Journals Library website for further project information.
Topics: Child; Female; Humans; Male; Cost-Benefit Analysis; Dermatitis, Atopic; Eczema; Emollients; Ointments; Quality of Life; Severity of Illness Index; Child, Preschool
PubMed: 37924282
DOI: 10.3310/GZQW6681 -
Clinical and Experimental Dermatology May 2022Topical tacrolimus is used off-label in young children, but data are limited on its use in children under 2 years of age and for long-term treatment.
BACKGROUND
Topical tacrolimus is used off-label in young children, but data are limited on its use in children under 2 years of age and for long-term treatment.
AIM
To compare safety differences between topical tacrolimus (0.03% and 0.1% ointments) and topical corticosteroids (mild and moderate potency) in young children with atopic dermatitis (AD).
METHODS
We conducted a 36-month follow-up study with 152 young children aged 1-3 years with moderate to severe AD. The children were followed up prospectively, and data were collected on infections, disease severity, growth parameters, vaccination responses and other relevant laboratory tests were gathered.
RESULTS
There were no significant differences between the treatment groups for skin-related infections (SRIs) (P = 0.20), non-SRIs (P = 0.20), growth parameters height (P = 0.60), body weight (P = 0.81), Eczema Area and Severity Index (EASI) (P = 0.19), vaccination responses (P = 0.62), serum cortisone levels (P = 0.23) or serum levels of interleukin (IL)-4, IL-10, IL-12, IL-31 and interferon-γ. EASI decreased significantly in both groups (P < 0.001). In the tacrolimus group, nine patients (11.68%) had detectable tacrolimus blood concentrations at the 1-week visit. There were no malignancies or severe infections during the study, and blood eosinophil counts were similar in both groups.
CONCLUSIONS
Topical tacrolimus (0.03% and 0.1%) and topical corticosteroids (mild and moderate potency) are safe to use in young children with moderate to severe AD, and have comparable efficacy and safety profiles.
Topics: Administration, Topical; Child; Child, Preschool; Dermatitis, Atopic; Dermatologic Agents; Follow-Up Studies; Glucocorticoids; Humans; Immunosuppressive Agents; Infant; Ointments; Tacrolimus; Treatment Outcome
PubMed: 34798685
DOI: 10.1111/ced.15024 -
Scientific Reports Aug 2022The role of angiotensin receptor blocker in wound healing and cutaneous fibrosis has become a hotspot in recent years. We have developed a losartan cream that is...
The role of angiotensin receptor blocker in wound healing and cutaneous fibrosis has become a hotspot in recent years. We have developed a losartan cream that is comparable to triamcinolone ointment in inhibiting scarring. Considering the effects of chitosan and asiaticoside on wound healing and scarring, we added them to the losartan cream this time and improved the formula, expecting to get a better anti-scarring effect. The effects of creams were investigated on mouse scar model with triamcinolone ointment, onion extract gel, and commercial asiaticoside cream set as positive controls. A preliminary exploration of the mechanism involved in TGF-β/Smad pathway was performed in vivo and in vitro. With all results of anti-scarring, the compound losartan cream (containing chitosan, asiaticoside, and losartan) shows the best effect, followed by the chitosan asiaticoside cream. The treatment of the compound losartan cream inhibited expression of TGF-β1, collagen, and Smads, and decreased phosphorylation of Smad in vivo. These inhibitory effects were also confirmed in vitro. Our findings indicated that the compound losartan cream could inhibit scarring via TGF-β/Smad pathway. This cream might be an effective option for scar treatment.
Topics: Animals; Chitosan; Cicatrix; Losartan; Mice; Ointments; Signal Transduction; Smad Proteins; Transforming Growth Factor beta1; Triamcinolone
PubMed: 35995975
DOI: 10.1038/s41598-022-17686-y -
International Journal For Vitamin and... Oct 2022Vitamin B12, a water-soluble vitamin, plays a vital role in the formation of hematopoietic stem cells and has been associated with oral mucosal diseases, mainly... (Review)
Review
Vitamin B12, a water-soluble vitamin, plays a vital role in the formation of hematopoietic stem cells and has been associated with oral mucosal diseases, mainly recurrent aphthous stomatitis (RAS). The latter is a debilitating condition, and B12 was proposed as a potential treatment given its role in regenerating oral mucosal tissue. There is conflicting evidence that B12 deficiency causes RAS. Five of the seven randomized controlled trials reviewed used the inactive form of B12 (cyanocobalamin) as intervention, while the other two used the active form (methylcobalamin). Of the latter two, buccal discs (500 μg B12) showed significant improvement and reduced perceived pain in 77% of the subjects, and submucosal injections showed a significant difference in pain, starting from the second day. Moreover, three studies administered vitamin B12 sublingually with different dosages, which revealed that the higher dose (1000 μg) achieved a significant reduction in outbreaks, number, and duration of ulcers, especially after six months. Multivitamins showed no difference in new RAS episodes and duration. Injectable B12 was compared with the oral form, and nearly 50% of the injection group reported a desired response by the eighth week. An ointment form (500 μg) showed a significant reduction in pain levels after two days of treatment. Based on the available literature, we suggest that a daily dose of 1000 μg of vitamin B12 sublingually for six months can be used to treat RAS. Nevertheless, this conclusion should be considered tentative due to the lack of high quality, large scale studies.
Topics: Humans; Ointments; Pain; Stomatitis, Aphthous; Vitamin B 12; Vitamins; Water
PubMed: 33103958
DOI: 10.1024/0300-9831/a000684 -
Journal of Oleo Science Dec 2022Eucalyptol is a major volatile constituent among well-known wound healing medicinal plants. The current study evaluated eucalyptol wound healing activity in the rat's...
Eucalyptol is a major volatile constituent among well-known wound healing medicinal plants. The current study evaluated eucalyptol wound healing activity in the rat's third-degree skin-burn model. The parameters, i.e., skin-healing, oxidative/antioxidant markers, pro-/anti-inflammatory markers, were evaluated after 1- and 2-weeks of treatment regimens with 5% eucalyptol ointment. Eucalyptol-loaded ointment base of 5% w/w strength was formulated using fusion method and physically evaluated for consistency, stability, and homogeneity. A 25-rats were divided randomly into intact, negative control (untreated), silver sulfadiazine (SS, positive control), 1-week, and 2-weeks treated eucalyptol groups. Using an aluminum cylinder (120℃, 10 second duration), 3-degree skin burns were created on the rat's dorsum. Skin biopsies were collected at the end of the experiment for biochemical and histological investigations. Compared to the negative group; time-dependent wound size reduction and decreased edema were observed in eucalyptol-treated animals. Histopathological examinations demonstrated epidermis integrity, decreased neutrophil, and increased capillaries number in the 2-weeks and SS groups, compared to the negative and 1-week treated eucalyptol groups. Compared to the untreated animals, the 1- and 2-weeks eucalyptol treated groups' demonstrated significantly increased antioxidant superoxide dismutase (SOD, p=0.002 and p=0.003, respectively) and reduced lipid peroxide (LP, p=0.005 and p=0.0006, respectively). However, a significant increment of catalase (CAT, p=0.0009) was found only in the 2-weeks of eucalyptol group at a level of 2.42 ± 0.39 ng/g compared to 1.14 ± 0.04 ng/g in the untreated animals. Also, significant reductions in the cytokines, IL-1b, IL-6, and TNF-α (p < 0.05); and increase in the pro-angiogenic marker, IL-10, were detected in the 2-weeks (p=0.001) and SS (p=0.002) treated animals compared to the negative and 1-week eucalyptol treated groups. The study concluded that eucalyptol induced significant duration-based wound healing properties attributed to its antioxidant and anti-inflammatory effects.
Topics: Rats; Animals; Ointments; Antioxidants; Eucalyptol; Wound Healing; Burns; Skin; Anti-Inflammatory Agents
PubMed: 36336343
DOI: 10.5650/jos.ess22214 -
Oral Surgery, Oral Medicine, Oral... Sep 2021We examined whether steroid ointment (0.1% dexamethasone) is an effective treatment for mucoceles.
OBJECTIVE
We examined whether steroid ointment (0.1% dexamethasone) is an effective treatment for mucoceles.
STUDY DESIGN
Using a retrospective cohort study design, a statistical study was conducted of 91 patients diagnosed with mucoceles at the Department of Dental and Oral Surgery, Saga University Hospital, Saga, Japan, between January 2006 and December 2016. The patients' age and sex; shape, size, and site of the lesion; duration; and treatment response rate were evaluated.
RESULTS
The most frequent site of mucoceles was the lower labial mucosa, and several were <10 mm in size. The age of onset was often <20 years, with no sex-based differences. The treatment response rate was 65.8% for steroid ointment and 100% for surgical removal. In the subgroup analysis according to each clinical factor, some subgroups showed statistically nonsignificant differences compared with the surgery group. Among them, the older age and short disease duration subgroups showed small risk differences, suggesting that application of ointment may lead to a response in these subgroups.
CONCLUSIONS
Although its response rate was lower than that of surgical removal, topical steroid application is a noninvasive and useful treatment method that can be used for patients in whom surgical treatment is infeasible.
Topics: Adult; Aged; Humans; Mucocele; Ointments; Oral Surgical Procedures; Retrospective Studies; Steroids; Young Adult
PubMed: 34140272
DOI: 10.1016/j.oooo.2021.04.054 -
Burns : Journal of the International... Mar 2021Effective treatments for non-healing burn wounds are an unmet need for 95% of burn sufferers. Approaches currently available to treat non-healing burn wounds are not...
Effective treatments for non-healing burn wounds are an unmet need for 95% of burn sufferers. Approaches currently available to treat non-healing burn wounds are not satisfactory due to undesirable side-effects or expense. The anti-oxidation and antibacterial activities of walnuts are recommended for treating chronic diseases. Walnut ointment has been developed and successfully applied to treat non-healing burn wounds in our hospital for decades. We report herein a detailed retrospective case review examining patients' response to the walnut ointment. The walnut ointment has shortened healing time of non-healing burn wounds and improved clinical outcomes. In order to investigate the mechanism of action, walnut ointment has been applied on wounds of porcine full-thickness burn wound models. Histological and immunohistochemical analysis indicated our walnut ointment supports wound healing through promoting keratinocyte proliferation and differentiation. Taken together, we recommend the walnut ointment offers an effective and economical treatment for patients presenting with non-healing burn wounds.
Topics: Animals; Burns; Emollients; Humans; Juglans; Ointments; Retrospective Studies; Swine; Wound Healing
PubMed: 32736884
DOI: 10.1016/j.burns.2020.06.032 -
Orbit (Amsterdam, Netherlands) Aug 2021The aim of the study is to describe intracanalicular antibiotic ointment loading as a treatment option for canaliculitis.
AIM
The aim of the study is to describe intracanalicular antibiotic ointment loading as a treatment option for canaliculitis.
MATERIAL AND METHODS
It was an interventional prospective study. The study was conducted over a 3 year period from June 2015 to June 2018. All patients of canaliculitis managed with intracanalicular antibiotic ointment loading and with a minimum follow up of 3 months were included in the study. The antibiotic ointment was loaded into the canaliculus based on the antibiotic sensitivity of the material expressed out from the canaliculus. Patients' demographics, clinical details, microbiological profile and management outcomes were evaluated.
RESULTS
A total of 24 patients were included in the study. Mean age at presentation was 58.41 ± 9.4 years. The right eye was involved in 15 (62.5%, = .0424) cases. The incidence of lower canaliculus involvement (14, 58.33%, = .022) was significantly higher as compared to the upper canaliculus (8, 33.33%). Staphylococcus epidermidis and Actinomyces israelii (6, 25%) were the most commonly isolated organisms. Mean number of intracanalicular antibiotic loading sessions required was 4.21 ± 1.69 (range 2-8). Complete resolution of canaliculitis was seen in all (100%) cases.
CONCLUSION
Canalicular antibiotic ointment loading is a minimally invasive, safe, and effective procedure. It preserves the anatomy and function of the punctum and canaliculus and can be considered as one of the management options for canaliculitis.
Topics: Actinomyces; Anti-Bacterial Agents; Canaliculitis; Dacryocystitis; Humans; Ointments; Prospective Studies
PubMed: 32787481
DOI: 10.1080/01676830.2020.1801763 -
CMAJ Open 2021Topical nitroglycerin (TNG) ointment has been used for almost 3 decades to treat neonatal peripheral tissue ischemia, but this product is now no longer being produced by...
BACKGROUND
Topical nitroglycerin (TNG) ointment has been used for almost 3 decades to treat neonatal peripheral tissue ischemia, but this product is now no longer being produced by its Canadian manufacturer. Our aim was to investigate the efficacy and safety of TNG products in newborns in neonatal intensive care units.
METHODS
In this systematic review we searched Embase, CINAHL, MEDLINE, PubMed and Web of Science from inception to April 2020 for studies on the use of TNG products (TNG ointment, TNG spray, glyceryl trinitrate [GTN] patch) for the treatment of neonatal tissue ischemia. We did not apply language or study design limitations. Animal studies and duplicate records were excluded. Two reviewers screened and extracted data. The Tool for Evaluating the Methodological Quality of Case Reports and Case Series was used to assess the risk of bias of individual studies.
RESULTS
We included 23 articles (20 case reports, 2 case series and 1 retrospective audit) describing the use of TNG ointment, TNG spray or GTN patch in the treatment of 39 tissue ischemia events in 37 newborns. Twenty-three (62.2%), 12 (32.4%), 1 (2.7%) and 1 (2.7%) infants received TNG ointment, GTN patch, both TNG ointment and GTN patch, and TNG spray, respectively. Nineteen (76.0%) and 7 (53.8%) injuries treated with TNG ointment and GTN patch showed complete recovery, respectively. Two (16.7%) infants treated with GTN patch experienced adverse events (i.e., methemoglobinemia) requiring treatment discontinuation.
INTERPRETATION
TNG ointment presents a safe therapeutic modality for salvage therapy of neonatal tissue ischemia. Engagement of stakeholders is essential to address its recent commercial inaccessibility in Canada.
Topics: Administration, Cutaneous; Catheterization, Peripheral; Humans; Infant, Newborn; Intensive Care Units, Neonatal; Ischemia; Nitroglycerin; Ointments; Salvage Therapy; Vasodilator Agents
PubMed: 33731426
DOI: 10.9778/cmajo.20200129 -
Acta Cirurgica Brasileira 2022To investigate the active ingredients of walnut ointment (WO) and its mechanism in repairing wounds.
PURPOSE
To investigate the active ingredients of walnut ointment (WO) and its mechanism in repairing wounds.
METHODS
The ingredients of WO were detected by gas chromatography-mass spectrometry. The effect of linoleic acid (LA) was tested by in vitro Alamar Blue (AB) reagent. Image J software, histological and immunohistochemical analysis were used to confirm the healing effect of LA in the porcine skin model. The animals were euthanized after the experiment by injection of pentobarbital sodium.
RESULTS
LA, 24% in WO, promotes keratinocytes and fibroblasts proliferation, which were 50.09% and 15.07% respectively higher than control (p < 0.05). The healing rate of the LA group (96.02% ± 2%, 98.58% ± 0.78%) was higher than the saline group (82.11% ± 3.37%, 88.72% ± 1.73%) at week 3 and week 4 (p < 0.05). The epidermal thickness of the LA was 0.16 ± 0.04 mm greater and the expression of the P63 and CK10 proteins was stronger in the LA group than the control (p < 0.05).
CONCLUSIONS
LA, which is the main components in WO can promote full-thickness burning wounds (FBWs) by stimulating cell proliferation and differentiation.
Topics: Animals; Swine; Juglans; Ointments; Linoleic Acid; Wound Healing; Accidents
PubMed: 36449813
DOI: 10.1590/acb370902