Evaluation of Laser-assisted Drug Delivery of Bimatoprost for the Treatment of Hypertrophic Scar Hypopigmentation: A Within Patient-Controlled Trial in Skin of Color
Medstar Health Research Institute
Summary
Patients who have hypo-pigmented burn scar will have two scars chosen and randomized to treated scar and control scar. The subject will then have both scars treated with fractional ablative CO2 laser (FLSR). The treated scar will have bimatoprost delivered through the laser channels, while the control will have the vehicle (normal saline) only delivered. The treatment will continue for 14 days with twice daily application. The scars will then be monitored at a 2-week follow-up visit where levels of melanin will be evaluated. Tissue punch biopsies will also be used to evaluate the mechanism of action of bimatoprost. Treatment will occur for 6 sessions at 4-6 week intervals including follow- up visits and evaluations.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Age ≥ 18 years 2. Cutaneous trauma resulting in hypopigmented scar 3. 2 different hypopigmented scars (at least 30cm2 each) with at least 2 inches of normal skin, hyperpigmented scar, or hypopigmented scar separating each hypopigmented study site scar Exclusion Criteria 1. Target hypopigmented scar to face or genitalia 2. Known allergy to bimatoprost 3. Known allergy to lidocaine 4. Positive urine pregnancy test in women of childbearing potential (per point of care test) 5. Lactating women (self-reported) 6. Prisoner status
Interventions
- DrugBimatoprost
Bimatoprost will be delivered with laser
- DrugSaline
Saline control will be delivered with laser
Location
- MedStar Washington Hospital CenterWashington D.C., District of Columbia