Clinical Research Directory

Development and Efficacy Tests of Cannabinoid, Prebiotic, and Postbiotic-based Face Serum and Cream

The study includes the evaluation of efficacy of face serum/cream in healthy volunteers aged 25-60 years with the following methods: a) self-assessment questionnaire b) biophysical organological measurements of skin elasticity, skin microtopography, transepidermal water loss and stratum corneum hydration.

Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles

The goal of this clinical trial is to evaluate the safety and efficacy of the monopolar radiofrequency therapy device developed by CLASSYS Inc. for improving facial and periorbital wrinkles. This is a prospective, multicenter, evaluator-blinded, randomized, parallel-controlled, non-inferiority clinical trial. The main questions the study aims to answer are: Does the monopolar radiofrequency device improve the appearance of facial and periorbital wrinkles? Is the safety profile of the monopolar radiofrequency device acceptable? Researchers will compare the investigational device to the Thermage CPT System (Solta Medical Co., Ltd.) to see if the monopolar radiofrequency device is non-inferior in terms of wrinkle improvement. Participants will: Undergo a single treatment session with either the investigational device or the control device. Be followed up for a period of 3 months to assess wrinkle improvement and safety outcomes. The primary outcome will be the improvement in facial and periorbital wrinkles, measured by the Facial Wrinkle and Elasticity Scale (FWES), 3 months post-treatment. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS) and a Visual Analog Scale (VAS) for pain. Safety evaluations will include adverse event (AE) and serious adverse event (SAE) monitoring.

Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women

This study will systematically quantify the effects of protein pacing and intermittent fasting (P-IF) on total and regional (abdominal) body composition (lean mass and fat mass), blood glucose and lipids, and anti-aging biomarkers, hunger ratings, and the gut microbiome in 40 overweight/obese adult men (n=20) and women (n=20) following a 8-week weight loss intervention. Participants will be enrolled in the study as a single cohort and participate in a 8-week weight loss (WL) trial consisting of a single dietary intervention phase. The purpose of the additional 12 month follow up case study (in addition to the initial 12-month case study period) is to scientifically document a significant weight loss and improved body composition following combined protein pacing intermittent fasting nutrition and a safe, effective exercise program in a study participant who achieved successful weight loss maintenance during the previous 12 month follow up study period.