Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma: A Randomized Clinical Trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Kessels J
PROVIDER: S-EPMC5817560 | biostudies-literature | 2017 Oct
REPOSITORIES: biostudies-literature
Publications
Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma: A Randomized Clinical Trial.
Kessels Janneke J Voeten Lotte L Nelemans Patty P Cleutjens Jack J Hillen Lisa Maria LM Mosterd Klara K Kelleners-Smeets Nicole W J NWJ
JAMA dermatology 20171001 10
Similar Datasets
Project description:BackgroundBasal cell carcinoma (BCC) is the most common cancer in the world and has a rising incidence. Current guidelines for low-risk BCC including superficial BCC (sBCC) recommend several treatment options including destructive treatment methods, such as cryosurgery with or without prior curettage or curettage and electrodesiccation. Curettage only (i.e. without subsequent cryosurgery or electrodesiccation) is a simple and quick destructive treatment method used for many benign skin lesions but has not been sufficiently evaluated for the treatment of sBCCs.ObjectivesThe objective was to compare the effectiveness of curettage vs. cryosurgery for sBCCs in terms of overall clinical clearance rates after 1 year as well as wound healing times.MethodsA single-centre non-inferiority clinical trial was conducted. Non-facial sBCCs with a diameter of 5-20 mm were randomised to either cryosurgery using one freeze-thaw cycle or curettage. At follow-up visits, treatment areas were evaluated regarding the presence of residual tumour after 3-6 months and recurrence after 1 year. Further, wound healing times were assessed.ResultsIn total, 228 sBCCs in 97 patients were included in the analysis. At 3-6 months, no residual tumours were seen in any of the treated areas. After 1 year, the clinical clearance rates for curettage and cryosurgery were 95.7% and 100%, respectively (P = 0.060). However, the non-inferiority analysis was inconclusive. Wound healing times were shorter for curettage (4 weeks) compared to cryosurgery (5 weeks; P < 0.0001). Overall, patient satisfaction at 1 year was high.ConclusionsBoth treatment methods showed high clinical clearance rates after 1 year, whilst curettage reduced the wound healing time.
| S-EPMC9544261 | biostudies-literature
Project description:BackgroundCutaneous bacterial infections are common in children and adults and frequently are caused by Staphylococcus aureus (S. aureus). Treatment failures with topical agents are not uncommon and have been shown to be secondary to bacterial resistance.ObjectiveTo determine clinical and bacteriological efficacy of retapamulin ointment 1% in treatment of patients with cutaneous bacterial infections caused by methicillin-resistant S. aureus (MRSA) and other bacteria.MethodsProspective, nonrandomized, uncontrolled, open label, single center trial conducted between April 2008 and November 2012 that evaluated efficacy of retapamulin ointment 1% in the treatment of impetigo, folliculitis, and other minor soft tissue infections in children and adults. Fifty patients, who presented to a dermatology outpatient clinic and were clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic, were screened. Thirty-eight patients were enrolled and received treatment: topical retapamulin ointment 1% twice daily for 5 days. Seven patients were MRSA positive and qualified for the primary efficacy population. One patient withdrew due to an adverse event. Clinical and microbiological exams were performed at baseline and follow-up 5 to 7 days later to assess clinical, microbiological, and therapeutic responses. Primary outcome was clinical response at follow-up in primary efficacy population with MRSA isolated as the baseline pathogen. Secondary outcomes included clinical, microbiologic, and therapeutic responses in patients who were culture positive for any species of bacteria.ResultsClinical response at follow-up in the primary efficacy population (MRSA-positive patients) was not sufficiently powered to demonstrate significance; however, outcomes were excellent, with 7 of 7 patients demonstrating clinical success (5 of 7) or clinical improvement (2 of 7) at follow-up. Barring lack of significance due to small total sample size for patients who were culture positive for any species of bacteria (n = 35), overall success rates were favorable for clinical, microbiologic, and therapeutic responses with values of 66%, 97%, and 69%, respectively. Adverse events (AEs) were mild or moderate in severity. No serious AEs were reported.ConclusionSafety profile appears favorable given the low number of AEs. Study design limits conclusions that can be drawn. Nevertheless, this study supports use of topical retapamulin 1% ointment in treatment of cutaneous bacterial infections, particularly those caused by S. aureus, including MRSA.
| S-EPMC5418665 | biostudies-literature
Project description:BackgroundSeveral observational studies have suggested differences in the risk factor profile between patients with superficial basal cell carcinomas (BCCs) and non-superficial BCCs.ObjectiveTo test the reproducibility of previous study findings and to find new genetic and non-genetic predictors for patients with a superficial first BCC.MethodsA total of 14.628 participants of northwestern European descent aged 45 years or older from a prospective population-based cohort study (Rotterdam Study) were linked with the Dutch Pathology Registry (PALGA) of whom 1528 were identified as BCC patients. After exclusion, 948 eligible BCC patients remained for further non-genetic analyses and 1014 for genetic analyses. We included 11 phenotypic, environmental and tumour-specific characteristics, and 20 candidate single nucleotide polymorphisms (SNP) as potential predictors for patients with a superficial first BCC. We performed binary logistic multivariable regression analyses.ResultsWe found that patients with a superficial first BCC were significantly younger, almost two times more often female and 12-18 times more likely to have their BCC on the trunk or extremities than patients with a non-superficial first BCC. One SNP (rs12203592), mapped to IRF4, looked promising (OR 1.83, 95% CI 1.13-2.97, P-value <0.05), but after adjustment for multiple testing, no significant differences in genetic make-up between superficial BCC and non-superficial BCC patients were found.ConclusionWe conclude that patients with a superficial BCC differ from non-superficial BCC patients with respect to environmental factors (tumour localization as a proxy for UVR exposure) and phenotypic characteristics (age and sex), but we found no difference in genotype. As superficial BCC patients develop their first BCCs at a younger age, they could be at higher lifetime risk for subsequent skin cancers and therefore be an important group for secondary prevention.
| S-EPMC6593991 | biostudies-literature
Project description:BackgroundElectrochemotherapy (ECT), by combining manageable cytotoxic agents with short electric pulses, represents an effective palliative skin-directed therapy. The accumulated evidence indicates that ECT stands out as a safe and well-tolerated alternative treatment for patients with multiple or large basal cell carcinoma (BCC), who are not suitable for conventional treatments. However, long-term data and shared indications are lacking.MethodsIn this observational study, we retrospectively analyzed 84 prospectively collected patients with multiple, recurrent or locally advanced BCC who were not candidate for standard therapies and received bleomycin-based ECT according to the European Standard Operative Procedures of ECT, from 2006 to 2016.ResultsDisease extent was local, locally advanced and metastatic in 40 (48%), 41 (49%) and 3 (3%), respectively. Forty-four (52%) individuals had multiple BCCs. Grade 3 skin toxicity after ECT was observed in 6% of cases. Clearance rate was 50% (95% CI 39-61%). Primary presentation (p = 0.004), tumor size <3 cm (p < 0.001), well-defined borders (p = 0.021), absence of tumor ulceration (p = 0.001), non-aggressive BCC histology (p = 0.046) and age ≤69 years were associated with higher complete response rate. In patients with local BCC, the clearance rate was 72.5 and 85% after one or two ECT cycles, respectively. In the laBCC group, 32 patients (78%) achieved an objective response. Five-year recurrence rate for local and laBCC was 20 and 38%, respectively (p ≤ 0.001).ConclusionsOne or two ECT cycles with bleomycin may be a valuable palliative treatment in well-selected patients with multiple BCCs and favorable tumor features. Validation of predictive factors will be imperative to match patients with optimal ECT treatment modalities. Management of laBCC with ECT warrants further investigation. Trial registration ISRCTN14633165 Registered 24 March 2017 (retrospectively registered).
| S-EPMC5452531 | biostudies-literature
Project description:BackgroundPhotodynamic therapy (PDT) is a noninvasive treatment for patients with superficial basal-cell carcinoma (sBCC). The efficacy of PDT may vary with different photosensitizers and treatment schedules.ObjectiveOur objective was to evaluate whether fractionated 5-aminolevulinic acid 20% (ALA)-PDT is superior to conventional two-stage methyl aminolevulinate (MAL)-PDT for sBCC.MethodsWe present the 5 years results of a single-blind, randomized, multicenter trial. 162 patients with a histologically confirmed primary sBCC were randomized to fractionated ALA-PDT or MAL-PDT.ResultsThe 5-year tumor-free survival rate was 70.7% (95% CI 58.2-80.1%) for ALA-PDT and 76.5% (95% CI 64.4-85.0%) for MAL-PDT. In the first 3 years, there was no significant difference in risk of treatment failure (HR = 1.53, p = 0.283), but in the long-term, the risk of recurrence was significantly lower following MAL-PDT compared to ALA-PDT (HR = 0.125, p = 0.049). As judged by patients, the esthetic result was good-excellent in 96.8% (61/63) and 94.4% (56/59) of patients treated with ALA-PDT and MAL-PDT, respectively (p = 0.631).ConclusionThe long-term efficacy is significantly higher for conventional two-stage MAL-PDT than for fractionated ALA-PDT, whereas there was no significant difference in esthetic outcome between the treatments at 5 years after treatment. These results indicate that fractionated ALA-PDT offers no benefit over conventional two-stage MAL-PDT.
| S-EPMC9677860 | biostudies-literature
Project description:ImportanceDisseminated superficial actinic porokeratosis (DSAP) is an inherited or sporadic disorder of keratinization associated with germline variations. There is no effective standard of care therapy for DSAP, but treatment with topical lovastatin combined with cholesterol cream has shown promise.ObjectivesTo evaluate and compare the safety and efficacy of topical lovastatin 2% plus cholesterol 2% cream (lovastatin-cholesterol) and topical lovastatin 2% cream (lovastatin) alone in adults diagnosed with DSAP.Design, setting, and participantsThis patient- and assessor-blinded, randomized clinical trial was conducted at the Medical University of South Carolina between August 3, 2020, and April 28, 2021. Nonpregnant adults with a previous clinical or histological diagnosis of DSAP were eligible. Data were blindly analyzed after study completion.InterventionsParticipants were randomized to once- or twice-daily application of either lovastatin-cholesterol cream (n = 17) or lovastatin cream (n = 14) to symptomatic regions for 12 weeks.Main outcomes and measuresThe primary efficacy measure was the effect of the treatment on DSAP at the end of treatment (12 weeks) as measured by the DSAP General Assessment Severity Index (DSAP-GASI; scored from 0-4, with 0 indicating clear and 4 indicating severe). Treatment efficacy was based on investigator-standardized photographs provided by the participants because of the need for evaluation via telehealth during the COVID-19 pandemic. Secondary efficacy measures included patient-reported outcomes, application frequency, and adverse events (AEs).ResultsOf the 87 participants screened, 32 were enrolled. One participant randomized to receive lovastatin-cholesterol did not receive the intervention, leaving 17 participants (mean [range] age, 59.2 [40-83] years; 13 females [76.5%]; all White) allocated to receive lovastatin-cholesterol treatment and 14 participants (13 female [92.9%]; mean (range) age, 53.7 [33-71] years; all White) to receive lovastatin treatment. Twelve participants in each treatment group qualified for the analysis. Disease severity decreased from week 1 to week 12 by 50.0% (from 3.08 [95% CI, 2.57-3.60] to 1.54 (95% CI, 1.04-2.05] points on the DSAP-GASI; P < .001) in the lovastatin-cholesterol group and 51.4% (from 2.92 [95% CI, 2.40-3.43] to 1.50 [95% CI, 0.99-2.01] points; P < .001) in the lovastatin group. There was no significant difference between the treatment groups according to application frequency at the end of 12 weeks. Adverse events reported included myalgia (n = 2), elevation in the creatine kinase level (n = 1), application discomfort (n = 4), and rash (n = 1). No serious AEs occurred, and all participants with an AE were able to complete the study.Conclusions and relevanceThis randomized clinical trial found improvements in DSAP severity in both treatment groups, without serious AEs, indicating a limited benefit with the addition of cholesterol. These results suggest that lovastatin cream may be a new primary treatment option for patients diagnosed with DSAP.Trial registrationClinicalTrials.gov Identifier: NCT04359823.
| S-EPMC10034663 | biostudies-literature
Project description:BackgroundBasal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream which enhances the body's immune response, may help deal with the number of cases that occur in low-risk sites, especially when good cosmetic results and home use without surgery are needed.This study aims 1. To compare excisional surgery with imiquimod cream for nodular or superficial basal cell carcinoma in low risk sites, with respect to 3 year clinical clearance, cost-effectiveness and cosmetic results. 2. To ascertain if certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment.Methods/designFive hundred participants with low risk nodular or superficial basal cell carcinoma will be recruited from hospitals to this multi-centre, randomised, parallel group, controlled phase III trial. Treatment in the imiquimod group is for 6 weeks for superficial basal cell carcinoma and 12 weeks for nodular basal cell carcinoma. Both treatment groups are followed up in clinic for 3 years. Primary outcome variable: the proportion of participants with clinical evidence of success (no recurrence) at 3 years. The primary outcome will be compared between the two treatment groups. Secondary outcomes include: i) clinical success at 1, 2 and 5 years, ii) time to first recurrence, iii) cosmetic appearance of lesion site after treatment, iv) level of pain, and v) cost-effectiveness. Safety and tolerability data will also be reported.DiscussionThis study protocol describes a pragmatic randomised controlled trial which it is hoped will address the above uncertainties. Three-year results will be available towards the end of 2010.Trial registrationMeta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.
| S-EPMC2877028 | biostudies-literature
Project description: Not available
| S-EPMC6659355 | biostudies-literature
Project description:Bifidobacterium and Lactobacillus Probiotics and Gut Dysbiosis in Preterm Infants: The PRIMAL Randomized Clinical Trial
| PRJEB85138 | ENA
Project description:Bifidobacterium and Lactobacillus Probiotics and Gut Dysbiosis in Preterm Infants: The PRIMAL Randomized Clinical Trial
| PRJEB85277 | ENA