NCT02681224

TR-987 vs. Placebo Following Fractionated CO2 Laser Resurfacing of the Chest

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A single site, double-blind, randomized, placebo-controlled, clinical study comparing the difference between a novel healing gel and a placebo gel on post laser-resurfacing chests.

Detailed description

This is a double-blind, randomized, placebo-controlled, chest clinical study with a single study site. Forty subjects will receive fractionated CO2 laser resurfacing of the chest. . Immediately following the procedure (Day 0), postoperative gel randomized to the chest (TR-987 or placebo), will be applied with a thickness of 1-2 mm by a non-blinded coordinator, along with a split-chest Silon TSR bandage. Subjects will return for follow up on Day 1, with the gel and split chest Silon TSR© bandages applied by non-blinded coordinator during visit, with further follow-up on Days 6, 8, 10, 13 and 28. Both subjects and evaluating investigator will be blinded to randomization schedule (performed by an unblinded coordinator). Subject will apply gels and split chest Silon TSR© bandages at home on Days 2, 3 and 4 when not visiting clinic.

Conditions

• Exposure Laser

Interventions

Type	Name	Description
OTHER	TR987 Gel with Silon Bandage	Novel healing gel with occlusive dressing
OTHER	TR987 without Silon Bandage	Novel healing gel without occlusive dressing
OTHER	Placebo Gel with Silon Bandage	Placebo gel with occlusive dressing
OTHER	Placebo Gel without Silon Bandage	Placebo Gel without occlusive dressing

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2017-01-01
• First posted: 2016-02-12
• Last updated: 2017-03-01

Locations

1 site across 1 country: United States