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.
Background A microneedling pen has been cleared by the US Food and Drug Administration and is indicated for improving the appearance of facial acne scars in adults. Objectives The objective of this study was to assess the effectiveness of this microneedling pen for treating wrinkles. This paper focusses 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 four monthly microneedling procedures at depths up to 2.5 mm. Wrinkle assessments were performed by two trained blinded raters by comparing images of each subject at baseline and at 90 days post-procedure. 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 for the treatment areas of the face and neck. Results The study was completed by 32 subjects. Wrinkle assessments demonstrated significant improvement in the neck areas (p<.001). The SGAIS and CGAIS showed signficant improvements at 90 days post-treatment (for each, p<.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 (87.5%), and would recommend microneedling to friends and family members (80.6%). Conclusions Microneedling is a viable, minimally invasive option for treating wrinkles of the neck
BackgroundAcne 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.ObjectivesTest the safety and efficacy of microneedling as an effective treatment modality for acne vulgaris.MethodsSubjects 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.ResultsThere 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.ConclusionThis 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.
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