Keloid

Researchers are evaluating the drug 9MW3811 in a randomized, double-blind, placebo-controlled Phase II study involving patients with pathological scars. The study aims to assess the drugs safety, tolerability, pharmacokinetics, immunogenicity, and preliminary effectiveness in improving scar conditions. Participants will have scars that have not improved spontaneously in the past six months and meet certain severity criteria. Participants will receive multiple intravenous infusions of either low, middle, or high doses of 9MW3811 or a matching placebo according to the study protocol. The treatment phase includes administration over a period up to 12 weeks, with dosing schedules designed to monitor responses and side effects closely. The study compares the effects of the different dosage levels of 9MW3811 against placebo. During the study, participants will undergo regular assessments including modified Vancouver Scar Scale scoring, patient and observer scar evaluations, quality of life questionnaires, vital sign checks, physical exams, ECGs, and laboratory tests. Pharmacokinetic properties such as plasma concentration and antibody development will be monitored up to day 85. The study includes careful safety monitoring and will follow participants for up to 12 weeks after treatment begins.

This research aims to compare two types of purse-string closures used to close circular surgical wounds intra-dermal and transcutaneous. The study focuses on scar appearance and post-operative complications, using a split wound model where each participants wound is closed by both methods on different halves. Researchers want to see if these two closure techniques result in similar cosmetic outcomes and safety profiles using validated scar assessment tools. Participants will have their surgical wounds closed with both techniques, one on each half of the wound, with the side assignments randomized. Intra-dermal purse-string closure involves placing sutures under the skin surface, while transcutaneous purse-string closure places sutures through the skin surface. Both are cinched like a coin purse to close the wound. This study uses a randomized, evaluator-blinded design to compare the effectiveness of these methods. Participants will be followed for three months post-surgery, during which the scars will be evaluated using the Patient Observer Scar Assessment Scale POSAS and the trace-to-tape method to measure scar width. Researchers will also monitor and record any complications or adverse events during this time. The study requires participants to return for a follow-up visit to assess these outcomes and complete the study involvement.

This trial investigates the use of a tie-over bolster dressing to reduce scarring after surgery on the head and face. Researchers want to see if applying this special gauze over stitches on half of a surgical wound can improve healing and reduce scar formation. The study focuses on patients undergoing cutaneous surgery with primary closure on the head or neck, aiming to compare traditional stitches with this bolster dressing method. Participants will have their surgical wound closed with standard stitches on one side, while the other side will receive stitches plus a tie-over bolster dressing secured by non-absorbable sutures. This bolster applies pressure to stabilize the wound and reduce tension, which may help minimize scar appearance. The study uses a randomized, single-blind, split-wound design, allowing each participant to serve as their own control. During the study, participants will be assessed at 3 months post-surgery using the Patient Observer Scar Assessment Score POSAS to evaluate scar appearance from both observer and patient perspectives. Scar width will also be measured, and any complications or adverse events related to treatment will be recorded. Participants must be willing to return for follow-up visits to complete these outcome assessments and monitor healing progress.

Keloids are benign skin lesions characterized by excessive growth beyond the original wound boundaries, driven by fibroblasts which play a key role in scar formation. This trial evaluates the use of 68Ga-RGD PETCT imaging to help diagnose keloid scars and assess treatment effectiveness. The study is a prospective investigation sponsored by Peking Union Medical College Hospital. Participants diagnosed with keloids will receive a single intravenous injection of 68Ga-RGD tracer at a dose of 18.5-22.2MBq 0.5-0.6 mCiKg. This tracer is used in PETCT scans to image keloid lesions. The study uses a single-group design where all participants undergo this imaging procedure. During the study, researchers will monitor participants for up to one year, correlating PETCT imaging results with clinical symptoms and laboratory tests. The study includes baseline assessments and follow-up evaluations to measure diagnostic accuracy and treatment response. Participation lasts from enrollment until the primary outcome assessment at one year.

Researchers are evaluating a new artificial intelligence AI tool designed to assist primary care providers in assessing skin conditions. This AI-powered dermatology image reference app works with a smartphone to provide reference images, helping providers make diagnoses using their medical training. The study aims to compare diagnoses made by primary care providers using the AI tool to those of a panel of dermatologists, considered the gold standard. The research is supported by the Advanced Research Projects Agency for Health ARPA-H and focuses on improving diagnostic accuracy and care in real-world clinical settings. The study involves primary care providers using the Belle AI tool, which analyzes images captured via a smartphone app and identifies over 2,000 skin conditions based on a large image database. Providers use the app during patient visits to capture images and receive differential diagnoses, which they review before making final decisions. After the initial visit, participants receive notifications to submit follow-up images using the app over a two-week period. Providers reassess diagnoses based on updated AI analysis, and follow-up visits may be scheduled or canceled depending on results. Providers receive training on the app and give feedback through surveys. Participants present with a primary dermatological complaint and consent to study procedures, including using the smartphone app to submit images. Researchers monitor diagnosis accuracy compared to a dermatology review committee consensus and assess economic impact and provider experience. The study lasts about 14 days per participant, with ongoing documentation in electronic medical records and continuous case review to determine care needs or resolution.

Researchers are evaluating two ways of delivering autologous nanofat grafts to treat post-burn and traumatic atrophic scars. The study compares injections of nanofat grafts with microneedling combined with nanofat grafts to see which method better improves scar appearance. This interventional trial is sponsored by Alexandria University and focuses on adults with scars lasting more than six months. Participants will have two scars with similar properties treated differently one scar or part of a large scar will receive nanofat graft injections, while the other scar or part will be treated with microneedling combined with nanofat grafts. Both treatments involve procedures using the patients own nanofat tissue. The study is non-randomized and does not use masking. During the study, researchers will assess changes in the scars using the Patient and Observer Scar Assessment Scale POSAS six months after treatment. Participants must be adults aged 18 to 60 years with scars older than six months and not currently receiving other scar treatments. The study excludes certain types of scars and participants with specific medical conditions. The total follow-up period for outcomes is six months after the procedures.

Researchers are studying the use of the AVAVA Device, a 1550nm Non-Ablative Fractional Laser, to treat various dermatologic conditions including acne, acne scars, wrinkles, pigment lesions, and skin texture disorders. The study aims to collect and analyze patient feedback on their overall experience with the device treatment. The primary focus is on responses to post-treatment questionnaires, while secondary measures include evaluations by physicians and patients regarding improvements and side effects. Participants will receive treatment using the AVAVA Device targeting their dermatologic condition. The study includes follow-up periods at 3, 6, and 12 months after the final treatment to assess outcomes. During these times, trained dermatologists will review before and after images, and both physicians and subjects will complete satisfaction and clinical improvement scales. The treatment process involves digital photography and adherence to specific skincare and sun exposure guidelines. Throughout the study, participants will complete questionnaires immediately after treatment and during follow-up visits to report their experience and tolerance of the procedure, including pain levels. Researchers will monitor the skins response and improvements over time through imaging and clinical assessments. The study requires participants to comply with study instructions, maintain consistent skincare, and attend scheduled visits. The total participation duration spans from initial treatment through 12 months of follow-up.

Researchers are evaluating the long-term prognostic value of macrovascular and microvascular coronary artery stenoses in different types of cardiomyopathies, including ischemic, hypertrophic, dilated, and restrictive forms. The study aims to understand how bystander coronary artery disease and coronary microvascular disease affect outcomes in patients with these heart conditions. This observational research is conducted across five centers in France to provide insight into the impact of these diseases on cardiovascular prognosis. Participants with various cardiomyopathies will undergo coronary angiography, cardiac magnetic resonance imaging CMR, tomographic coronary artery angiography, single-photon emission computed tomography SPECT, and rest and stress trans-thoracic echocardiography TTE. Macrovascular coronary artery disease is defined by specific stenosis levels and ischemia confirmation, while microvascular disease is identified using indices like the index of microvascular resistance IMR and myocardial perfusion heterogeneity imaging MPHI. The study records these imaging results to evaluate their prognostic significance. During the study, major adverse cardiovascular events MACE will be assessed at 1 year, 2 years, and 5 years after enrollment. Participants are monitored through detailed cardiovascular imaging and clinical evaluations to track their health outcomes over time. This long-term follow-up will help researchers understand the relationship between coronary artery conditions and cardiomyopathy progression, contributing valuable information for patient care and management.

Researchers are evaluating the cosmetic results of surgical scars from three different techniques used for initial skin incision during total mastectomy procedures without immediate breast reconstruction. The study compares the use of a scalpel, standard electrocautery, and the PEAK PlasmaBlade device. The goal is to determine if there is a significant difference in scar appearance among these methods and to inform future choices for breast surgery equipment. Participants will be randomly assigned to one of three groups one using a scalpel for the initial incision followed by either standard electrocautery or PEAK PlasmaBlade to complete the surgery, one using PEAK PlasmaBlade for the entire surgery, and one using standard electrocautery for the entire surgery. The study is conducted as a double-blind, randomized controlled trial. Scar appearance will be assessed at 2 to 4 weeks, 6 months, and 12 months after surgery by two independent observers who do not know which device was used. Patients will also report their outcomes using the SCAR-Q questionnaire. Additional measures include monitoring for post-operative complications such as seroma, hematoma, bruising, wound infection, and pain, as well as operative time, blood loss, and drainage duration. The study is expected to run through December 2025.

This research aims to evaluate the cost-effectiveness of extracorporeal shock wave therapy ESWT combined with standard rehabilitation compared to standard rehabilitation alone for adults with hypertrophic post-burn scars. The study focuses on clinical outcomes like pain intensity, itching, and scar quality, as well as economic outcomes including cost per quality-adjusted life year QALY, direct medical costs, and indirect costs such as absenteeism and reduced productivity. The findings will help guide health policy and resource allocation for advanced burn rehabilitation treatments. Participants aged 18 to 65 with hypertrophic scars at least 6 months after a burn injury will be randomly assigned to one of two groups. The experimental group will receive ESWT weekly for 8 weeks alongside a rehabilitation program involving physical therapy, scar management exercises, and patient education. The control group will receive the standard rehabilitation therapy alone, which includes physical, occupational, and scar-specific therapies, matched in frequency and duration to the experimental group but without ESWT. During the study, participants will be assessed at baseline and at 1, 3, and 6 months after treatment. Evaluations will include measures of pain using a Visual Analog Scale, itching with the Itch Man Scale, and scar quality using the Vancouver Scar Scale. Researchers will also monitor costs related to therapy sessions, equipment, hospital visits, and work productivity. This comprehensive follow-up will provide both clinical and economic data over a 6-month period to understand the impact of combining ESWT with rehabilitation.