RECRUITING

Treatment of Hypopigmented Scars With Bimatoprost

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-18
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06122090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Alison Ross, BA
CONTACT
202-877-5170
fbsrlresearch@medstar.net

Study Locations (Sites)

MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-18
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2023-07-18
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Scars
  • Hypopigmented Scar
  • Hypopigmented Skin
  • Burn Scar
  • Scarring
  • Cicatrix, Hypertrophic
  • Cicatrix
  • Pigmentation Disorder
  • Burns Laser