Topical Application of Skin Biome Care Regimen Containing Live Cultures and Ferments of Cutibacterium acnes defendens strain XYCM42 and the Impact on Clinical Outcomes Following Microneedle-induced Skin Remodeling.

Background: The skin, our body's largest organ, hosts a complex microbiome that plays a pivotal role in maintaining health and protecting against pathogens. Even slight disruptions to this delicate balance can influence skin health and disease. Among the diverse microbial community, Cutibacterium acnes (C. acnes) subspecies defendens is known for its positive contribution to skin health. However, the interaction between living microbe probiotics and wound healing after aesthetic procedures, such as microneedling, remains unexplored. Methods: Our study included 40 participants with acne scars who underwent four microneedling sessions spaced three weeks apart. They were randomly assigned to Group 1, receiving a regimen with live C. acnes defendens strain XYCM42, or Group 2, following a conventional skincare routine with a cleanser, moisturizer, and sunscreen. Our study assessed various endpoints, including the Clinician's Global Aesthetic Improvement Scale (CGAIS), clinical safety, improvement in acne scars using Goodman and Baron's Qualitative and Quantitative Acne Scars Grading Scale and Subject's Global Aesthetic Improvement Scale (SGAIS). Results: Our analysis of live and photo grading data for CGAIS unveiled a statistically significant difference between the two groups, with Group 1 (XYCM42-based regimen) showing remarkable improvement. A similar positive trend was observed in the photo grading for CGAIS. Additionally, participant diaries indicated that Group 1 experienced a faster decline in posttreatment parameters, including erythema, swelling, burning/tingling, and itching. Conclusion: Integrating a microbiome-optimized, probiotic XYCM42-based regimen with microneedling demonstrated a high safety profile and enhanced treatment outcomes. These findings mark a milestone in aesthetic dermatology, supporting innovative microbiome-based approaches to improve skin health and aesthetics.

Study to determine the safety and efficacy of microneedling as an effective treatment for acne vulgaris.

Background: Acne is an inflammatory disease of the pilosebaceous unit that occurs primarily in adolescents. There is no current ideal treatment for acne vulgaris, as many mainstay prescription treatment modalities can compromise the skin microbiome or have deleterious health effects. Further research is needed to investigate novel treatment modalities that account for the importance of the skin microbiome. Other developing treatment modalities for acne are still taking a similar mode of action as current treatments by trying to eliminate Cutibacterium acnes despite growing evidence that some C. acnes strains may be symbiotic in nature. The perception that microneedling will exacerbate the disease state and trigger more acneic lesions via the spread of acne-associated microbes has hindered research investigating whether microneedling is a safe and effective treatment. This pilot clinical study challenges such perceptions by clinical assessment to determine if microneedling may produce beneficial treatment outcomes without disrupting critical skin structure or skin microbiome. Objectives: Test the safety and efficacy of microneedling as an effective treatment modality for acne vulgaris. Methods: Subjects were split into two groups, one group received three treatments 4 weeks apart, and the second group received four treatments 2 weeks apart. Subjects received an acne assessment by an expert clinical grader at all clinical visits. Results: There was a statistically significant reduction in both non-inflammatory and inflammatory lesions at the 2-month follow-up compared to the baseline for Group 1. Group 1 and Group 2 saw a decline of 48.20% and 54.00% in non-inflammatory lesions and 57.97% and 36.67% in inflammatory lesions, respectively, at their last visit compared to baseline. Conclusion: This study expands the utility of microneedling into a potential therapeutic modality for acne vulgaris. The data generated during the duration of this clinical study demonstrates that there is no scientific reason for microneedling to be contraindicated for acne. In this pilot, microneedling did not cause post-treatment complications and was seen to reduce acne lesions effectively. Thus, microneedling may have the potential to be a well-tolerated option for those suffering from acne, being a treatment that neither damages the sebaceous glands nor disrupts the skin microbiome.

Efficacy and tolerability of a microneedling device for treating wrinkles on the face.

OBJECTIVES: A microneedling pen has been cleared by the US Food and Drug Administration, indicated for improving the appearance of adult facial acne scars. The objective of this study was to assess the device's effectiveness for treating wrinkles of the face area. MATERIALS AND METHODS: Healthy adults seeking to improve the appearance of face wrinkles were enrolled (N = 35), receiving four monthly microneedling procedures by a trained aesthetician who treated the face skin per manufacturer instructions. Wrinkle assessments were performed by two trained blinded raters by comparing baseline images of each subject with images obtained at 90 days post-procedure. Subsequently, the two raters were unblinded for the Clinician's Global Aesthetic Improvement Scale (CGAIS) assessment. Subjects completed the Subject's Global Aesthetic Improvement Scale (SGAIS) and a Satisfaction Questionnaire at 30 and 90 days post-treatment. RESULTS: The study was completed by 32 subjects with a mean (SD) age of 56.3 (5.0) years. Wrinkle assessments demonstrated significant improvement in the face areas (p < 0.001). The SGAIS scores showed significant improvements after 30 and 90 days post-treatment (for each, p < 0.001). The CGAIS scores also showed significant improvements at 90 days post-treatment (p < 0.001). Most subjects reported some level of improvement in their appearance at 30 days (73.3%) and 90 days (68.8%) post-treatment. The satisfaction questionnaire showed high levels of improvement in wrinkles (93.8%), satisfaction with the treatment procedure (87.5%) and would recommend microneedling to friends and family members (80.6%) on the face and neck. CONCLUSION: Microneedling is a viable, minimally invasive option for treating wrinkles of the face. CLINICALTRIALS: gov Identifier: NCT03803059.

Characterization of a live Cutibacterium acnes subspecies defendens strain XYCM42 and clinical assessment as a topical regimen for general skin health and cosmesis.

BACKGROUND: When formulating topical products to treat skin diseases and addressing general skin health and cosmesis, most of the focus has traditionally been placed on how any given ingredient may impact the structure, function, and health of human skin elements. However, recent research is beginning to highlight the importance of the skin microbiome in relation to certain skin conditions and general cosmesis. Cutibacterium acnes is one of the most prolific skin-specific bacterial species. Research has shown that the species is divided into subspecies, some of which are thought to be beneficial to the skin. This paper aims to determine the efficacy of strainXYCM42, a C. acnes subspecies defendens derived strain designed to improve the health and appearance of the skin. METHODS: In vitro studies were performed on human keratinocyte and fibroblast monolayers, human peripheral blood mononuclear cells (PBMC), and skin explants to elucidate the effects of live XYCM42 cells and their ferment on human skin cells and tissues. Subsequently, clinical studies were performed using XYCM42-based topical regimens designed to deliver and support the engraftment of live XYCM42 cells onto subjects' skin. Two studies were performed, a 3-week pilot study (n = 10) and a 8-week pivotal study (n = 121). In the latter, 32 subjects were enrolled for an in-clinic portion for efficacy evaluation, with clinic visits occurring at Baseline, Week 1, Week 4, and Week 8. RESULTS: In vitro data suggest that XYCM42 and its ferment filtrate have potential to provide benefits to the skin via antioxidant, anti-inflammatory, and select antimicrobial activities. Clinical observation demonstrated that a XYCM42-containing regimen supports a healthy skin environment, promotes increased skin hydration, decreases erythema, calms the skin, and regulates sebum production. CONCLUSION: These studies provide further evidence that specific strains of C. acnes, such as XYCM42, have a more beneficial function regarding skin health and appearance than was previously thought. Appropriate use of formulations derived from symbiotic strains within the skin microbiome can support the development of novel, beneficial topicals.

Efficacy and Tolerability of a Microneedling Device for Treating Wrinkles on the Neck.

BACKGROUND: A microneedling pen has been cleared by the US FDA and is indicated for improving the appearance of facial acne scars in adults. OBJECTIVES: The aim of this study was to assess the effectiveness of this microneedling pen for treating wrinkles. This paper focuses on the results on the neck, an area of recent importance with video meetings placing physical stress on the neck area, leading to wrinkles. METHODS: Healthy adult men and women were enrolled (N = 35). Subjects received 4 monthly microneedling procedures at depths of up to 2.5 mm. Wrinkle assessments were performed by 2 trained blinded raters by comparing images of each subject at baseline and at 90 days postprocedure. The 2 raters were unblinded for the Clinician's Global Aesthetic Improvement Scale assessment. Subjects completed the Subject's Global Aesthetic Improvement Scale and a questionnaire regarding satisfaction with the treated areas of the face and neck at 30 and 90 days posttreatment. RESULTS: The study was completed by 32 subjects. Wrinkle assessments demonstrated significant improvement in the neck areas (P < 0.001). Both Global Aesthetic Improvement Scales showed significant improvements at 90 days posttreatment (P < 0.001). Most subjects reported some level of improvement in their appearance at 30 days (73.3%) and 90 days (68.8%) posttreatment. The satisfaction questionnaire showed high levels of improvement in wrinkles (93.8%), satisfaction with the results (87.5%), and would recommend microneedling to friends and family members (80.6%). CONCLUSIONS: Microneedling is a viable, minimally invasive option for treating wrin kles of the neck.

Case-control studies compare "apples and pears": Proposal for a retrospective cohort study in the USA of vaccination history in relation to subsequent childhood leukemia.

The role of vaccination in triggering childhood acute lymphoblastic leukemia (ALL) has been assessed in many studies. The results of these studies were found to be inconsistent. The core consistency and significance of all of these studies is the fact that, all these studies were only case-control based. After Greaves' discovery of the prenatal origin of childhood ALL it is perfectly clear that case-control studies compare genetically quite different populations, i.e. "apples and pears". The only way, this genetic shortcoming of case-control studies to be overcome, is simply to replace it by using cohort studies. Cohort studies, has two great shortcomings, the ethics and the lack of statistically sufficient number of unvaccinated children. The first shortcoming could be overcome by using the retrospective variant of cohort studies, whilst the second one by performing these studies in highly populated countries. The country of choice would be the United States of America.