Evaluation of Laser-assisted Drug Delivery of Bimatoprost for the Treatment of Hypertrophic Scar Hypopigmentation: A Within Patient-Controlled Trial in Skin of Color

If the subject agrees to take part in this study, the subject's scars will be looked at and the investigators will pick two sites that will be involved in the research. Each scar will be "randomized" into one of two study groups. One scar will be the treatment group which will be treated with standard of care therapies plus the fractionated ablative CO2 laser and topical bimatoprost drug. The other scar will be the control group which will be treated with standard of care therapies, the fractional ablative CO2 laser, and a control solution. Randomization means that either of the two scars has an equal chance of being designated as the treatment or control group. It is like flipping a coin. Neither the subject nor the investigators will choose what scar will be treated or control. Each half has a 50% chance of being placed in either group.

This study will take place in an outpatient setting. Subjects will not be admitted to the hospital overnight. Patients who enter the study will need to be able to follow up for regular appointments with the burn department.

Before the investigators start the laser treatment, the subject will come in for a pre-treatment visit where the investigators will collect information about the scars such as pictures, non-invasive probes, non-invasive imaging (ultrasound), and questionnaires filled out by the subject and the provider. These questionnaires will be related to the symptoms and appearance of scars. The questionnaires will also evaluate overall psychological health. There will also be a blood draw where less than 2 tablespoons of blood are collected. It is estimated this visit will take less than 1 hour. The investigators will also collect information from the medical record about prior surgical and medical history.

Laser treatments will occur at approximately 4-8-week intervals depending on what the Burn Center scheduling department allows. For completion of this study, the subject will undergo 6 laser treatments which should take about 6-12 months. During each laser treatment visit, the treated scar will have the drug (bimatoprost) rubbed on top of the scar while the subject is having their surgery. The subject will then continue to apply these drops to their scar for 14 days after the surgery, once in the morning and once at night. The drug will come in a bottle with a dropper top which the subject will apply a couple of drops to their scar and rub it in. The investigators will tell the subject how much drug to apply based on the size of their scar. This drug will be provided to the subject by the research pharmacy and will not be billed to the subject's insurance. The study team will call to remind the subject about their laser visits and to make sure they are applying the ointment for 14 days. The subject will apply the study drug to one scar and the control drug to the other scar. The investigators will label the containers so subjects will know which one to apply where. The subject will write down when they apply their medications in a diary entry that will be completed daily for 14 days after each laser procedures.

While most patients with burn scars undergo 6 treatments, and this is the goal for this study, sometimes depending on how the subject's scar is responding to treatment, they along with their clinical team may decide to stop treatments before the subject gets to 6 treatments, or continue after 6 treatments. Treatments of scars will stop when the clinical team elects to stop laser treatment.