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Treatment of Hypopigmented Scars With Bimatoprost

NCT06122090 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-05-03

No results posted yet for this study

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
  • Cicatrix, Hypertrophic
  • Cicatrix
  • Pigmentation Disorder
  • Burns Laser

Interventions

DRUG

Bimatoprost

Bimatoprost will be delivered with laser

DRUG

Saline

Saline control will be delivered with laser

Sponsors & Collaborators

  • Latham Fund

    collaborator UNKNOWN

  • Medstar Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2024-12-30
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06122090 on ClinicalTrials.gov