Treatment of Hypopigmented Scars With Bimatoprost

• Status: Recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute
• Collaborator: Latham Fund
• Treatments: Bimatoprost

Criteria

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