Alpharetta

Researchers are evaluating the long-term safety and effectiveness of Afimkibart (also known as RO7790121) in adults with Atopic Dermatitis who previously participated in Afimkibart clinical trials. This Phase 2 extension study aims to further understand the effects of this treatment over an extended period. Participants will receive Afimkibart through subcutaneous injections following a schedule outlined in the study protocol. The study specifically includes those who showed improvement in their skin condition during the prior trial and continued evaluation at the Week 36 follow-up visit. During the study, participants will undergo various assessments including clinical evaluations of their skin condition and completion of questionnaires about their quality of life and symptom severity. Safety will be closely monitored by tracking any adverse events from the start of the study and continuing up to six years. Blood samples will also be collected to study the drug's behavior in the body.

Researchers are evaluating the safety of OviTex PRS, a reinforced tissue matrix used in implant-based breast reconstruction surgeries, in women aged 18 to 75 years. This observational study looks at patients who previously received either permanent or resorbable OviTex PRS devices during immediate or two-stage unilateral or bilateral breast reconstructions, placed either above or below the chest muscle. The goal is to understand the safety profile of these devices and help guide future studies on their effectiveness. Participants in the study had undergone breast reconstruction surgery using OviTex PRS combined with implants, either permanent or resorbable types. The procedures included initial surgeries and any necessary exchange surgeries. The study collects data retrospectively and prospectively across multiple centers to assess outcomes related to the use of these devices. During the study, researchers track any significant adverse events within 24 months after implantation of the OviTex PRS device. Participants may be asked to return for follow-up visits, including photographic documentation. The study focuses on monitoring safety outcomes over two years, ensuring patients' recovery and device performance are carefully observed.

This research aims to evaluate the safety and effectiveness of NT 201 compared with a placebo in adults who have moderate to severe platysma prominence, which involves noticeable bands in the neck muscles. The study is a Phase 3 clinical trial conducted in the United States, focusing on assessing the impact of this treatment on these muscle bands using a specific rating scale. Participants will receive either NT 201, a botulinum toxin type A injection, or a placebo during the Main Period (MP) of the study. After this, there is an Open Label Extension Period (OLEX) where participants may continue to be observed or treated. The NT 201 is provided as a powder that is prepared for injection, and the study is designed as a randomized, double-blind, parallel-group trial across multiple centers. During the study, participants will be closely monitored with assessments that include both the investigator's and participant's ratings of platysma prominence using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D). The primary outcome is measured at Week 2 of the Main Period by evaluating the improvement in platysma appearance. Safety and efficacy will be carefully tracked throughout the study periods to ensure participant well-being and to gather comprehensive data on treatment effects.

Researchers are evaluating the safety and effectiveness of ELAPR002f injectable gel in adults with atrophic acne scars, which are flat or indented scars that develop after acne heals. These scars can significantly affect quality of life by lowering self-esteem and causing self-consciousness. This Phase 3 study involves participants with moderate to severe scars on both cheeks, aiming to assess how well ELAPR002f works compared to a saline control. Participants are divided into two cohorts. In Cohort 1, all participants receive ELAPR002f injectable gel through intradermal injections. In Cohort 2, participants are randomly assigned to receive either ELAPR002f or a saline active control, with a 1 in 4 chance of getting the saline. Each participant will receive three treatments over two months. The study involves approximately 395 adult participants at around 25 sites across the United States. During the study, participants will attend regular visits at clinics or hospitals for medical assessments, blood tests, and to check for side effects. Questionnaires will also be completed to monitor the treatment's effects. Participants will be followed for up to 12 months after the treatments to observe the long-term safety and effectiveness, including measuring changes in acne scar area, side effects, and any bodily changes.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are evaluating the long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

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 effectiveness of using brain magnetic resonance imaging (MRI) scans alone compared to combining MRI scans with prophylactic cranial irradiation (PCI) in treating patients with small cell lung cancer (SCLC). This phase III trial aims to determine if MRI surveillance alone is not worse than adding PCI in terms of overall survival. The study also looks at cognitive function, brain metastasis-free survival, and treatment side effects among patients with limited or extensive-stage SCLC. Participants are randomly assigned to one of two groups. One group receives PCI, which is radiation therapy focused on the brain, given over two weeks for 20 minutes per day, five days a week, along with scheduled MRI scans at 3, 6, 9, 12, 18, and 24 months. The other group undergoes MRI scans at the same intervals without receiving PCI. Both groups are monitored closely through these MRI scans to track any spread of cancer to the brain. During the study, patients will have regular MRI scans, cognitive assessments, and evaluations of side effects and survival outcomes up to two years after randomization. Blood samples will be collected for future research. Researchers will monitor overall survival, cognitive failure rates, and brain metastasis occurrence, aiming to understand if avoiding PCI might reduce side effects without compromising survival. Participant involvement includes multiple scheduled scans and tests over a two-year follow-up period.

Researchers are evaluating the GalaFLEX LITE
22 Scaffold for its safety and effectiveness in revision surgery to reduce the recurrence of capsular contracture and/or implant malposition in women undergoing breast implant revision after augmentation. This prospective, randomized, controlled study compares the GalaFLEX LITE
22 Scaffold to standard surgery without supportive matrices or acellular dermal matrices (ADM). The study focuses on patients with Baker grade III or IV capsular contracture, a common complication after breast augmentation affecting 10 to 20% of patients. Participants will be randomly assigned in a 2:1 ratio to receive either the GalaFLEX LITE
22 Scaffold, a bioabsorbable surgical mesh made from poly-4-hydroxybutyrate designed to reinforce soft tissue, or standard surgery without any scaffold. The trial will include between 250 and 530 treated breasts and uses an adaptive design to assess outcomes. The primary endpoint includes recurrence of capsular contracture or implant malposition needing surgery, breast infections requiring antibiotics within 90 days, or peri-implant fluid collections needing drainage within 10 to 90 days post-surgery. During the study, participants will be followed for 24 months after their revision surgery. Researchers will monitor the stability of the implant pocket and assess complications through clinical evaluations. Participants will attend regular follow-up visits to track outcomes, safety, and any adverse events. The study aims to provide detailed information on the effectiveness of the GalaFLEX LITE
22 Scaffold in improving surgical outcomes and reducing common post-augmentation complications over a two-year period.