RecruitingPhase 2NCT06122090

Treatment of Hypopigmented Scars With Bimatoprost

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


Sponsor

Medstar Health Research Institute

Enrollment

25 participants

Start Date

Jul 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Age ≥ 18 years
  • Cutaneous trauma resulting in hypopigmented scar
  • 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 Criteria6

  • Target hypopigmented scar to face or genitalia
  • Known allergy to bimatoprost
  • Known allergy to lidocaine
  • Positive urine pregnancy test in women of childbearing potential (per point of care test)
  • Lactating women (self-reported)
  • Prisoner status

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Interventions

DRUGBimatoprost

Bimatoprost will be delivered with laser

DRUGSaline

Saline control will be delivered with laser


Locations(1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

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NCT06122090


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