Manhattan Beach

This research aims to evaluate the effectiveness and safety of IPN10200 compared to a placebo in improving the appearance of moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows. These lines can become more noticeable with age or repeated facial expressions and may affect a person's appearance and confidence. The study is a Phase III trial involving adult participants with these moderate to severe glabellar lines. Participants will receive a single injection of either IPN10200, a lyophilised powder for solution injected into several sites across the glabellar region, or a placebo injection containing excipients without the active substance. The study consists of three periods: a screening period lasting up to 20 days to determine eligibility; a treatment period on Day 1 when the injection is given; and a follow-up period lasting 52 weeks with regular visits and one telephone call to monitor participants' health. During the study, participants will undergo various health assessments including blood sampling, physical exams, clinical evaluations, and electrocardiograms. They will also complete questionnaires and keep diaries to record their experience. The main outcome measured is the percentage of participants responding to treatment four weeks after baseline. Participants may stay in the study for up to 55 weeks and can withdraw consent at any time.

Researchers are conducting a non-interventional, open-label, observational study across multiple sites to collect real-world data on the use of an autologous hair follicle derived secretome topical cosmetic product. This product is studied as an addition to various medical aesthetic procedures, focusing on its application for conditions such as post-procedural erythema. The study includes adults aged 18 to 60 of any skin type who are planning to undergo these aesthetic treatments. Participants will use the Acorn Autologous Hair Follicle Secretome cosmetic product following their medical aesthetic procedures. The procedures involved include laser resurfacing of the face (ablative or non-ablative), Tixel treatment of the face, and treatments for acne and surgery scars combined with ablative or non-ablative laser or microneedling. Some hair-related treatments and procedures are closed to enrollment. The study observes real-world usage without intervening in treatment decisions. During the study, participants will be monitored for symptoms and downtime related to their procedures over a period of 1 to 7 days. Researchers will collect data on post-procedure symptoms and downtime using questionnaires to understand the product's impact as an adjunct to aesthetic procedures. The study ensures safety by excluding participants with conditions that may interfere with participation and by tracking any relevant health status changes throughout the observation period.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of VDPHL01, an oral investigational drug, in treating female patients with Androgenetic Alopecia (AGA), a genetic condition causing hair loss due to an excessive hair follicle response to hormones. This Phase 3, multi-center, double-blind study involves adult women aged 18 to 65 with mild to moderate AGA. The study aims to assess changes in hair counts and participants' evaluation of treatment benefit after 6 months. Participants will be randomly assigned to receive either VDPHL01 extended release tablets once daily or twice daily, or a placebo tablet. The study includes 11 visits over approximately 13 months: screening, baseline (day 1), weeks 2, months 1, 2, 4, 6, 8, 10, 12, and a final visit at month 13. During the study, participants must maintain consistent hair length, style, and color, and agree to have a micro dot tattoo placed on the scalp for photography and assessment. Throughout the trial, researchers will monitor hair growth through non-vellus target area hair counts and collect participants' feedback on treatment benefits at 6 months. The study involves multiple assessments including photography of the scalp, questionnaires, and general health evaluations. Safety and efficacy data will be collected until the final visit at month 13.