Treatment for hypopigmented scars using 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
This study is testing if a medication called bimatoprost can improve the color and appearance of light-colored burn scars in people by comparing it to a saline solution.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06122090 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of bimatoprost in treating hypopigmented burn scars. Patients with two eligible scars will have one treated with bimatoprost delivered through fractional ablative CO2 laser, while the other will receive a saline control. The treatment will occur over six sessions with follow-up visits to assess changes in melanin levels and scar appearance. Tissue biopsies will also be conducted to understand the mechanism of action of bimatoprost.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with two distinct hypopigmented scars resulting from cutaneous trauma.
Not a fit: Patients with hypopigmented scars located on the face or genitalia, or those with known allergies to bimatoprost or lidocaine, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the pigmentation and appearance of hypopigmented scars for patients.
How similar studies have performed: While the use of bimatoprost for scar treatment is relatively novel, similar approaches using other topical agents have shown promise in improving scar appearance.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Study coordinator: Alison Ross, BA
- Email: fbsrlresearch@medstar.net
- Phone: 202-877-5170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.