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Bacterial vaginosis (BV) is associated with an elevated vaginal pH and the presence of abnormal offensive discharge. It is common, often recurrent, and the most effective treatment regimen is unknown. 'Metronidazole Versus lactic acId for Treating bacterial vAginosis' (VITA) is a UK-based randomised controlled trial assessing clinical and cost-effectiveness of topical lactic acid gel compared to oral metronidazole antibiotic for treating second and subsequent BV episodes. Few BV trials report on women's preferences for treatment in the context of their own experiences. This qualitative study investigated the acceptability and tolerability of the two treatments. During the trial, semi-structured telephone interviews were undertaken between January-May 2018. A total of 33 women diagnosed with BV were consecutively sampled then interviewed from six sites across England. Thematic analysis was guided by the acceptability of health interventions framework. Potential causes of BV and its impact on women's lives were explored in addition to women's treatment preference and perceived treatment effectiveness. Although women felt antibiotics treat BV effectively, and were associated with longer time periods between episodes, they generally preferred using the lactic acid gel because of ease of use, once daily application and less side-effects. Women would recommend the lactic acid gel to others for mild cases of BV but to take antibiotics when more severe. The risk of antibiotic drug resistance was a common concern. Self-help medicating or self-decision to not treat was also evident due to prior experience of poor outcomes from treatment. Triggers of BV were attributed to personal hygiene habits-soaps used to wash the vagina and sexual practices such as unprotected sex. Acceptability and preference for topical lactic acid gel or oral metronidazole tablets in the treatment of recurrent BV was affected by personal choice relating to affective attitude, burden, ethicality, intervention coherence, opportunity costs, and self-efficacy. These differed depending on ease of use, tolerability and past experiences, but not necessarily based on perceived drug effectiveness. Knowledge of a patient preference for topical lactic acid gel therapy despite lower perceived effectiveness may be useful for clinicians when making treatment decisions.

Background Fragile X syndrome (FXS) is associated with dysregulated endocannabinoid signaling and may therefore respond to cannabidiol therapy. Design CONNECT-FX was a double-blind, randomized phase 3 trial assessing efficacy and safety of ZYN002, transdermal cannabidiol gel, for the treatment of behavioral symptoms in children and adolescents with FXS. Methods Patients were randomized to 12 weeks of ZYN002 (250 mg or 500 mg daily [weight-based]) or placebo, as add-on to standard of care. The primary endpoint assessed change in social avoidance (SA) measured by the Aberrant Behavior Checklist–Community Edition FXS (ABC-C FXS ) SA subscale in a full cohort of patients with a FXS full mutation, regardless of the FMR1 methylation status. Ad hoc analyses assessed efficacy in patients with ≥ 90% and 100% methylation of the promoter region of the FMR1 gene, in whom FMR1 gene silencing is most likely. Results A total of 212 patients, mean age 9.7 years, 75% males, were enrolled. A total of 169 (79.7%) patients presented with ≥ 90% methylation of the FMR1 promoter and full mutation of FMR1 . Although statistical significance for the primary endpoint was not achieved in the full cohort, significant improvement was demonstrated in patients with ≥ 90% methylation of FMR1 (nominal P  = 0.020). This group also achieved statistically significant improvements in Caregiver Global Impression‐Change in SA and isolation, irritable and disruptive behaviors, and social interactions (nominal P -values: P  = 0.038, P  = 0.028, and P  = 0.002). Similar results were seen in patients with 100% methylation of FMR1 . ZYN002 was safe and well tolerated. All treatment-emergent adverse events (TEAEs) were mild or moderate. The most common treatment-related TEAE was application site pain (ZYN002: 6.4%; placebo: 1.0%). Conclusions In CONNECT-FX, ZYN002 was well tolerated in patients with FXS and demonstrated evidence of efficacy with a favorable benefit risk relationship in patients with ≥ 90% methylation of the FMR1 gene, in whom gene silencing is most likely, and the impact of FXS is typically most severe. Trial registration The CONNECT-FX trial is registered on Clinicaltrials.gov (NCT03614663).

Adapalene is used for treatment of acne vulgaris, a common dermatological disease. Nano-based carriers have been developed to improve solubility and bioavailability of adapalene and other acne treatment drugs. In our previous report, tea tree oil nanoemulsion containing adapalene gel (TTO NE + ADA Gel) showed appropriate physical and biological properties such as stability, viscosity, pH, size, morphology and biocompatibility in an animal model. The present study was designed to assess efficacy and safety of the TTO NE + ADA Gel in comparison with 0.1% adapalene marketed gel (ADA Marketed Gel). A total of 100 patients were randomized to receive TTO NE + ADA Gel or ADA Marketed Gel, once daily at night, for 12 weeks. Analysis for efficacy was conducted by acne lesion count (total, inflammatory and non-inflammatory) and acne severity index at weeks 4, 8 and 12 using generalized estimating equation along with the safety assessments in each measurement for assessing dryness, erythema, burning sensation and irritation. Significantly better reduction in total, inflammatory, and non-inflammatory acne lesions were reported for TTO NE + ADA Gel as compared to the ADA Marketed Gel overall and on each measurement occasion ( p value  < 0.001 for all). Mean acne severity index also reduced with TTO NE + ADA Gel significantly in comparison with ADA Marketed Gel ( p value  < 0.001). Dryness was the most common adverse effect reported in both groups and it was higher in TTO NE + ADA Gel group. In conclusion, TTO NE + ADA Gel compared to ADA Marketed Gel appears more effective in the treatment of acne vulgaris, with no important change in adverse effects.

Background Hypertrophic scars, resulting from alterations in the normal processes of cutaneous wound healing, are characterized by proliferation of dermal tissue with excessive deposition of fibroblast-derived extracellular matrix proteins, especially collagen, over long periods, and by persistent inflammation and fibrosis. The present study aim to compare the efficacy of silicone gel versus combination of a 577-nm pro- yellow laser and silicone gel in the treatment of post-surgery hypertrophic scar. Methods This study is a randomized comparative study In the period from 14 January 2021 up to the end of January 2023. 30 patients with post-surgery hypertrophic scar divided into two groups: A: one half of scar was managed with 577 nm diode laser 3 sessions monthly combined with application of silicone gel at home. A + B: the entire scar was treated with silicone gel within six months who admitted to the Laser unit of the Dermatology and Andrology Department at Al-Azhar University Hospital, Assiut during the study period. Results Significant improvement in pigmentation, pliability, height and total Vancouver score. By comparing between silicone gel and combination of silicone gel and a 577 nm diode laser, the combination shows significant improving than silicone gel alone. The scar in the lip and breast area showed a significant higher improvement rate with yellow laser plus silicone gel compared to the other site. Conclusion Combination of silicone gel and yellow laser has significant effect in making surgical scars less distinct.

Background Oral thrush is the most common occurring fungal infection in the oral cavity in uncontrolled diabetic patients, it is treated by various antifungal drugs according to each case. This study aimed to evaluate the therapeutic effects of topical application of miconazole and miconazole-loaded chitosan nanoparticles in treatment of diabetic patients with oral candidiasis. Methods In this randomized controlled clinical trial. A total of 80 diabetic patients presenting with symptomatic oral candidiasis were randomly assigned into two treatment groups: miconazole and miconazole-loaded chitosan nanoparticles. The patients were treated for 28 days, and clinical assessments were conducted at baseline, 7, 14, 21 and 28 days. Clinical parameters, including signs and symptoms of oral candidiasis were evaluated and microbiological analysis was performed to determine the Candida species and assess their susceptibility to the antifungal agents. Statistical analysis was done to the categorical and numerical data using chi-square test and Kruskal Wallis test. Results The antifungal efficacy between the miconazole and miconazole-loaded chitosan nanoparticles (CS-MCZ) groups insignificant difference ( P  >  0.05) was observed. Both treatment modalities exhibited comparable effectiveness in controlling oral candidiasis symptoms and reducing Candida colonization as miconazole-loaded chitosan nanoparticles group showed a significant difference in the clinical improvement in respect of both signs and symptoms from baseline (70%) until the end of study at 28 days (5%) ( P  <  0.05) Moreover, miconazole-loaded chitosan nanoparticles, there was a significant reduction in the number of colonies forming units of Candida albicans from baseline until the end of the study at 28-day with P value  <  0.000. Conclusions This randomized controlled clinical trial and microbiological analysis demonstrate that both miconazole and miconazole-loaded chitosan nanoparticles are effective in the treatment of oral candidiasis in diabetic patients with no adverse reactions. Trial registration NCT06072716 with first registration first registration in 10/10/2023.

Optimal burn scar management has the potential to markedly improve the lives of children, but can require substantial healthcare resources. The study aimed to examine the cost-effectiveness of three scar management interventions: pressure garment; topical silicone gel; combined pressure garment and topical silicone gel therapy, alongside a randomised controlled trial of these interventions. Participants were children (n = 153) referred for burn scar management following grafting, spontaneous healing after acute burn injury, or reconstructive surgery. Healthcare resource use was costed from a health service perspective (6-months post-burn time-horizon). The mean total scar management cost was lowest in the topical silicone gel group ($382.87 (95% CI $337.72, $443.29)) compared to the pressure garment ($1327.02 (95% CI $1081.46, $1659.95)) and combined intervention $1605.97 ($1077.65, $2694.23)) groups. There were no significant between-group differences in Quality Adjusted Life Year estimates. There was a 70% probability that topical silicone gel dominated pressure garment therapy (was cheaper and more effective), a 29% probability that pressure garment therapy dominated combined therapy, and a 63% probability that topical silicone gel dominated combined therapy. In conclusion, topical silicone gel was the cheaper intervention, and may be favoured in the absence of clear clinical effect favouring pressure garment therapy or a combination of these management approaches. Trial registration: ACTRN12616001100482 (prospectively registered).

Background The study compared the clinical effectiveness of topical Tacrolimus (TAC) in patches or gel with Triamcinolone acetonide (TRI) gel for erosive/atrophic oral lichen planus (OLP) and investigated the influence of these therapies on Caspase-3 expression as a marker of apoptosis. Methods Thirty patients were randomly assigned into three equal groups to receive either topical TAC 0.1% patch twice daily, topical TAC 0.1% gel, or topical TRI 0.1% gel four times daily for 8 weeks. Each patient's clinical score (CS), visual analogue scale (VAS), and total atrophic area (TAA) of the marker lesion were measured at baseline, 2, 4, and 8 weeks of treatment, as well as after 4 weeks of treatment free period. Caspase-3 expression and lymphocytic counts (LC) were assessed in pre- and post-treatment biopsied stained sections. Results TAC patch resulted in a higher reduction in CS [− 14.00 (15.54%)] and VAS [− 70.21 (15.82%)] followed by TAC gel then TRI gel within the first two weeks. The reduction in VAS and TAA were significantly higher in TAC groups compared to TRI gel, although the difference between TAC treatment was not significant and this was observed throughout the treatment and follow-up periods. Caspase-3 expression increased in connective tissue in all groups. It decreased significantly within the epithelium in both TAC groups but increased in TRI gel. (LC) were significantly lowered with the TAC patch compared to other groups. The percentage change in Caspase-3 epithelial expression was significantly correlated to the CS, TAA, and LC. Conclusion Both TAC patch and gel significantly decreased pain and lesion size than TRI gel, with a significant reduction in Caspase-3 expression within the epithelium in comparison to the increase seen with TRI gel. The study protocol was registered at www.clinicaltrials.gov (NCT05139667) on 01/12/2021.

This randomised controlled clinical trial compared the efficacy of a standardised autologous platelet gel (RegenWound gel) (n = 48) with a standard care treatment (hydrocellular or hydrocolloid dressing) (n = 48) for the treatment of hard‐to‐heal foot ulcers in type 1 or 2 diabetes mellitus patients > 18 years old. The primary outcomes were the percentage of ulcers healed 6 weeks after treatment commenced. The secondary outcomes were the average healing time, the time course of the healing process, the local tolerance, and the acceptability of the treatment by the patient compared to the standard treatment. At the 6 weeks end‐of‐treatment visit (ETV), 56.5% of the patients in the RegenWound gel group and 20.0% of the patients in the control group had completely healed. Healing continued to evolve after the ETV and reached 77.3% at end‐of‐study visit 2 (12 weeks) in the RegenWound gel group, compared to 35.1% for the control group. The treatment was well tolerated and safe. RegenWound gel could be an effective treatment for diabetic foot ulcers, with most patients being healed within 6 weeks of treatment, and on average 1 to 2 treatments being needed. Trial Registration: ISRCTN10032417

Background Recurrent Aphthous Stomatitis (RAS) is one of the most common lesions of the oral mucosa. Herbal medicine can be used for the treatment of this disease. The present study aimed to compare the effects of topical application of Sage (Salvizan) and triamcinolone acetonide gels on RAS. Methods This double-blind clinical study recruited sixty patients with minor aphthous ulcers. Half of the patients were treated with Salvizan gel, and the other half were treated with oral triamcinolone acetonide gel. The effect of Salvizan topical gel was evaluated and compared with that of oral triamcinolone acetonide gel. Factors such as Pain recovery time, wound healing time, and pain level was evaluated. Data were analyzed by SPSS version 22 using independent t-test, paired t-test, repeated measures ANOVA, and survival analysis, including Kaplan-Meier and Cox regression. Results The mean duration of pain recovery was 1.5 days for Salvizan and 2.5 days for triamcinolone acetonide ( p  < 0.001). Moreover, the duration of wound healing was 3.3 days for Salvizan and 6 days for triamcinolone acetonide ( p  < 0.001). Patients’ satisfaction from factors such as taste and smell had no significant difference between the two groups. Conclusion The results of this study showed that Salvizan gel is very effective in the treatment of RAS. It was significantly better than triamcinolone acetonide in the pain recovery and wound healing. These promising results favor herbal treatments and show that they can be used more commonly for treating diseases such as RAS. Trial registration This study was approved by the ethics committee of Isfahan University of Medical Sciences (IR.MUI.RESEARCH.REC.1399.834) on 17/03/2021. It was also registered in the Iranian Registry of Clinical Trials (IRCT20100202003251N7).