Recruiting
Phase 2

Bimatoprost

Sponsor:

Medstar Health Research Institute

Code:

NCT06122090

Conditions

Scars

Hypopigmented Scar

Hypopigmented Skin

Burn Scar

Scarring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bimatoprost

Saline

Study Details

Brief 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.

Conditions

Scars

Hypopigmented Scar

Hypopigmented Skin

Burn Scar

Scarring

Study ID

NCT06122090

Start date

Jul 18, 2023

Status verified date

May, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Bimatoprost will be delivered to the scars using laser-assisted drug delivery in this arm

sham comparator: Control

Saline control will be delivered to the scars using laser-assisted drug delivery in this arm

Interventions

Bimatoprost

Bimatoprost will be delivered with laser

Saline

Saline control will be delivered with laser

Primary outcome measure

  • Area of pigmentation [ Time Frame: follow-up number 6, an average of 8 months ]

Central Contacts and Locations

Central contacts

Locations

MedStar Washington Hospital Center

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Bonnie Carney, PhD

bonnie.c.carney@medstar.net

More Information

Sponsor

Medstar Health Research Institute

Last update posted

May 3, 2024

Last verified

May, 2024

Keywords

  • burn hypertrophic scar
  • burn scar hypopigmentation
  • scar
  • hypopigmentation
  • dyschromia
  • pigmentation abnormality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2024-05-03.