Treatment of Hypopigmented Scars With Bimatoprost

NCT06122090 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 00006189
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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; Cicatrix, Hypertrophic; Cicatrix; Pigmentation Disorder; Burns Laser

Keywords

burn hypertrophic scar; burn scar hypopigmentation; scar; hypopigmentation; dyschromia; pigmentation abnormality

Outcome Measures

Primary Outcomes (1)

• Area of pigmentation

  area of pigmentation within control and treated scars

  follow-up number 6, an average of 8 months

Secondary Outcomes (4)

• Melanin Index

  follow-up number 6, an average of 8 months

• Differential gene expression of tyrosinase

  follow-up number 6, an average of 8 months

• Differential gene expression of tyrosinase-related protein 1

  follow-up number 6, an average of 8 months

• Differential gene expression of tyrosinase-related protein 2

  follow-up number 6, an average of 8 months

Other Outcomes (5)

• Patient and Observer Scar Assessment Scale (POSAS)

  follow-up number 6, an average of 8 months

• VanCouver Scar Scale

  follow-up number 6, an average of 8 months

• Non-invasive measurement of melanin

  follow-up number 6, an average of 8 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Drug: Bimatoprost

Control

SHAM COMPARATOR

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

Drug: Saline

Interventions

Bimatoprost DRUG

Bimatoprost will be delivered with laser

Treatment

Saline DRUG

Saline control will be delivered with laser

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Cutaneous trauma resulting in hypopigmented scar
• 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

You may not qualify if:

• Target hypopigmented scar to face or genitalia
• Known allergy to bimatoprost
• Known allergy to lidocaine
• Positive urine pregnancy test in women of childbearing potential (per point of care test)
• Lactating women (self-reported)
• Prisoner status

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Latham Fund: collaborator

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Cicatrix; Vitiligo; Cicatrix, Hypertrophic; Pigmentation Disorders; Hypopigmentation

Interventions

Bimatoprost; Sodium Chloride

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Alison Ross, BA

CONTACT

202-877-5170; fbsrlresearch@medstar.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Department of Burn Research, Principal Investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: November 8, 2023
• Study Start: July 18, 2023
• Primary Completion: December 30, 2024
• Study Completion: July 31, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

US (1)