NCT03403621

Hypertrophic Scar Prevention by Novel Topical Gel Application

Double Blind, Single-Center, Randomized, Within Subject Placebo, Phase I Study Evaluating the Effects of Novel Topical Gel in Prevention of Hypertrophic Scar Formation

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are trying to find out more about the side effects of topical (applied to the skin) Pentamidine, to determine if it is safe for use in people. They also want to find out if topical use of Pentamidine can help treat hypertrophic scars. Pentamidine is a medicine that is currently used to treat certain kinds of infection. It is most often given by intravenous (into a vein) or inhalation (through a breathing device). This medication is approved by the U.S. Food and Drug Administration (FDA) for use in these forms. Everyone in this study will receive topical Pentamidine (TP) in a silicone based gel (PCCA Pracasil Plus). Topical treatment of Pentamidine is still experimental and has not been formally tested for safety or effectiveness in a randomized control trial within the United States. The FDA has allowed the use of topical Pentamidine in this research study.

Detailed description

This study will investigate Pentamidine isethionate, compounded in a silicone-containing base, as adjuvant therapy to surgical scar excision to prevent adverse scarring and enhance skin rejuvenation.

Conditions

• Hypertrophic Scar

Interventions

Type	Name	Description
DRUG	Pentamidine Isethionate	Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
DRUG	Placebo	No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.

Timeline

• Start date: 2018-03-05
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2018-01-18
• Last updated: 2023-11-22
• Results posted: 2023-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study