Human Clinical Trials Using Topical Bakuchiol Formulations for the Treatment of Skin Disorders: A Systematic Review.

BACKGROUND: Bakuchiol is a topical cosmeceutical marketed as a retinoid alternative. Human clinical trial data on bakuchiol’s efficacy for the treatment of dermatologic conditions has not been thoroughly evaluated. OBJECTIVE: To review human clinical trials using topical formulations containing bakuchiol in the treatment of facial skin disorders. MATERIALS AND METHODS: A comprehensive electronic search of Cochrane Library, PubMed, EMBASE, and Web of Science was conducted on August 28, 2022, using the search terms “bakuchiol” and “UP256.” Study characteristics, measured outcomes, significant results, and stated limitations were extracted.  Results: Fifteen human clinical trials were analyzed. Dermatologic conditions treated included aging, acne, and post-inflammatory hyperpigmentation. Twelve trials were unblinded, open-label trials without a control group. Ten trials used a combination therapy containing bakuchiol. Four trials did not specify the dose or concentration of bakuchiol in treatment regimens. The heterogeneity of treatments, study designs, and measured outcomes makes meta-analysis unfeasible.  Conclusion: Trials lack methodologic rigor, which introduces a high risk of bias in reported outcomes. The use of combination topical formulations containing bakuchiol limits the comparison of bakuchiol’s efficacy with retinoids. Continued research with an improved trial design is needed.J Drugs Dermatol. 2024;23(4): doi:10.36849/JDD.7763.

Blepharoplasty Online: Critical Analysis of Content and Patient Comprehensibility.

INTRODUCTION: Patients frequently turn to online information for decision-making factors about aesthetic procedures. The quality of online medical content is an essential supplement to clinical education. These resources assist patients in understanding the risks, benefits, and appropriateness of their desired procedure. This study examines the breadth and readability of online blepharoplasty information, elucidating its educational utility. METHODS: A depersonalized Google search was conducted using the Startpage Search Engine, investigating key phrases, "blepharoplasty decision making factors", "eye lift decision making factors", and "eyelid lift decision making factors". The first three pages of results for each search term, totaling 90 links were screened. Data were extracted for various decision-making factors, subspecialty, gender, and readability. RESULTS: Twenty-six websites met inclusion for analysis. Thirteen websites were plastic surgery based, five otolaryngology (ENT), five ophthalmology/oculoplastic, one oral-maxillofacial (OMFS), and two mixed-based practices. Most blepharoplasty webpages identified were that of private practice and male surgeons. Half were subspecialties other than plastic surgery. Thirteen common decision-making factors were identified. The most common factors addressed across all texts were recovery followed by cosmetic and functional goals. The least discussed were genetic factors. Average Readability exceeded the 12th grade. There were no significant differences in readability means among subspecialties. CONCLUSION: This study examines the online blepharoplasty sphere among US-based practices providing clinical education to patients. No appreciable differences among gender, subspecialty, and readability on decision-making factors were found, highlighting a consistency among surgeons. Most websites fell short of readability standards, however, emphasizing a need for clearer information to patients. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The First In-Human Application of Continuous Low-Irradiance Phototherapy for Chronic Wounds: A Pilot Study.

BACKGROUND: Polymicrobial colonization and resultant biofilm formation significantly impair the process of wound healing. Stagnant tissue repair processes predispose patients to serious complications including systemic infection and limb amputation. Continuous Low-Irradiance Phototherapy (CLIP) is a novel therapeutic approach that delivers blue light at low irradiance for extended periods of time. Bench and preclinical work in the literature indicates that 405 nm light avoids thermal injury of healthy tissue, promotes a cytokine milieu favoring re-epithelialization and angiogenesis, and prevents bacterial and biofilm growth.  Objective: This is the first in-human evaluation of a technology that delivers continuous low-irradiance 405 nm light to chronic wounds. The objective of this study was to determine the safety, feasibility, and ergonomics of this device for the treatment of chronic wounds in adult human subjects. This was not a randomized study to determine device efficacy, although data on outcome were collected. METHODS: In this prospective observational pilot study, participants received the intervention 24 hours per day, 7 days per week, for 4 weeks. Cohort I was conducted from December 2018 to March 2019, with Cohorts II and III ongoing. 25 study participants were recruited by referral (Cohort I: 5 participants, Cohort II: 10 participants, Cohort III: 10 participants). Our primary endpoint was to monitor for safety, assess usability by nurses and physicians, and evaluate patient comfort. The secondary endpoint, although not randomized nor directly compared with standard intervention, was the percentage area reduction (PAR) of the wound.  Results: No adverse events or subject discomfort occurred with the CLIP intervention. The staff treating the study participants reported no ergonomic or compliance issues with the use of the device. The device received high scores in categories assessing practicality and ease of use. There was an average PAR of 29% (SD = 0.42).  Conclusion: This study serves as the first in-human evaluation of extended low-irradiance 405 nm light for chronic wound therapy. The device appears safe and easy to use and had no compliance issues in the outpatient setting. Study participants who received CLIP without interruption saw either partial or complete reduction in wound area.  J Drugs Dermatol. 2023;22(11):1111-1117     doi:10.36849/JDD.7206.

Operative options for extracranial nasal dermoid cysts: A meta-analysis.

BACKGROUND: Nasal dermoid cysts are surgically treated using external incision, open rhinoplasty, transnasal endoscopy, or combined approaches. It is unclear how these approaches differ with regard to the incidence of adverse events. METHODS: We conducted a systematic review of studies on the surgical management of midline nasal dermoids. Following data abstraction, we carried out a series of single-arm meta-analyses to estimate summary risks of recurrence and combined adverse events (recurrence, revision, infection, or readmission) according to the surgical approach. RESULTS: Forty-three eligible studies published between 1958 and 2020 reported on 439 cases of nasal dermoid cysts. Treatment approaches included external incision (25 studies), rhinoplasty (15 studies), and transnasal endoscopy (5 studies). To our knowledge, no study has compared outcome incidence between the surgical approaches. External incision had the lowest summary incidence of both recurrence (1.78% [95% CI: 0.57%, 3.65%]) and combined adverse events (4.94% [95% CI: 2.72%, 7.77%]). Rhinoplasty had a higher incidence of recurrence (4.81% [95% CI: 0.91%, 11.6%]) and combined adverse events (8.32% [95% CI: 2.77%, 16.5%]), and transnasal endoscopy had the highest incidence of recurrence (the only reported adverse event; 7.89% [95% CI: 0%, 28.9%]). CONCLUSION: Our results suggest that the incidence of adverse events was lowest among patients who were subjected to external incision for nasal dermoid removal. Incidence was higher for patients who underwent rhinoplasty and the highest for patients who underwent transnasal endoscopy. Future work on this topic should include well-designed prospective studies that compare rates of adverse events and cosmetic outcomes between surgical approaches.

The Epidemiology of Necrotizing Fasciitis at a Rural Level 1 Trauma Center During the COVID-19 Pandemic.

INTRODUCTION: The impact of the COVID-19 pandemic on non-COVID-19 pathologies has been experienced worldwide. While people appropriately avoided social interactions, many also avoided essential medical care for acute and chronic conditions. This delay in seeking care has been associated with increased morbidity and mortality in several conditions, including life-threatening infections such as necrotizing fasciitis. METHODS: We retrospectively reviewed the records of patients that presented to the University of Vermont Medical Center for necrotizing fasciitis during the 1-year period following the declaration of a global pandemic on March 11, 2020. We subsequently compared this data with that of the previous 4 years. RESULTS: During the period of March 12, 2020 to March 12, 2021, there were 17 cases of newly diagnosed necrotizing fasciitis. Compared with an average per year of 8 cases over the previous 4 years, this represents a 113% percent increase in cases of necrotizing fasciitis during the study period (P = .071861). Out of the 17 cases, 4 patients died during their admission, producing a case-fatality rate of 23.5%. This represents a statistically significant increase from previous years (P = .003248), where the average case-fatality rate was 6.3%. CONCLUSION: Our study demonstrates a substantial increase in cases of necrotizing fasciitis following the onset of the coronavirus pandemic. A significant increase in the case-fatality rate was also observed. Given the growing body of literature describing the negative impact of the pandemic on non-COVID-19 morbidity and mortality, our study posits necrotizing fasciitis as one of many affected pathologies. LEVEL OF EVIDENCE: Level IV. Epidemiological.

Content and Readability of Online Recommendations for Breast Implant Size Selection.

Breast augmentation is one of the most frequently performed aesthetic procedures in the United States. Online information is often used by patients to make decisions when undergoing cosmetic procedures. It is vital that online medical information includes relevant decision-making factors and uses language that is understandable to broad patient audiences. Ideally, online resources should aid patient decisions in aesthetic surgical planning, especially implant size selection for breast augmentation. We describe patient decision-making factors and readability of breast implant size selection recommended by private practice plastic surgery webpages. Methods: Using a depersonalized, anonymous query to Google search engine, the terms "breast implant size factors" and "breast implant size decision" were searched, and 52 plastic surgery private practice webpages were identified. Webpages were analyzed for reported decision-making factors of implant size selection. Readability analyses of webpages were performed with Readability Studio and Hemingway Editor. Results: The two major decision-making factors for implant size selection reported by webpages were body/tissue-based measurements and surgeon input. Ten factors related to patient lifestyle, surgical goals, and procedural options were also identified. Average webpage scores for five readability measures exceeded recommended levels for medical information. Conclusions: Reported decision-making factors for implant size selection emphasize a plastic surgeon's expertise but may enhance the patient's role in preoperative planning. Webpages describing breast implant size selection exceed the sixth and eighth grade reading levels recommended by the AMA and NIH, respectively. Improving the readability of webpages will refine the role of online medical information in preoperative planning of breast augmentation.

Antimicrobial Efficacy of Continuous Low-Irradiance Phototherapy Against Multidrug-Resistant Organisms.

Objective: The objective of this study is to report on the bactericidal effects of blue light administered at low irradiance for extended periods of time. Background: Multidrug-resistant organisms (MDROs) utilize biofilms that can limit the efficacy of antibiotics, causing infection and impaired wound healing. Unlike high-energy systems, continuous low-irradiance phototherapy (CLIP) avoids thermal injury of healthy tissue and can be delivered for extended periods. Methods: Four MDRO species, two of which contained different antibiotic resistance genes, were exposed to 405 nm irradiation in vitro. The microbes were incrementally exposed to increasing dose-rates (irradiance; mW/cm2) over a 24-h time period. Cell viability and biomass reduction assays were conducted to quantify the antibacterial/antibiofilm effects. Primary human dermal fibroblasts were also exposed to CLIP to assess whether these dose-rates would impair cell viability or proliferation. Results: CLIP exposure utilizing irradiances as low as 2.78 mW/cm2 delivered over 24 h resulted in a >3.0-log (>99.9%) and >2.0-log (>99.0%) microbial load reduction when organisms were grown in planktonic and biofilm-encapsulated conditions, respectively. Crystal violet biofilm assays revealed destruction of extracellular biofilm architecture following CLIP exposure. Human fibroblast viability and proliferation were unaffected by CLIP. Conclusions: This is the first report demonstrating the antimicrobial efficacy of CLIP for MDROs found in infected wounds. CLIP did not compromise cultured human fibroblast growth and survival. This study demonstrated that very low fluence rates (irradiances) delivered over extended periods are potently antimicrobial. There is translational potential for CLIP to be fabricated as a wearable device that would enable continuous ambulatory care of wounds.