NCT03392935

Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then 2 additional follow-up visits. Photographs will be taken at each visit and rated by blinded reviewers after the study to determine efficacy.

Detailed description

The main objective of this study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. A secondary objective of this study is to better understand the 1540 nanometer Erbium glass laser and its impact on the skin. This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then have 2 additional follow-up visits (no laser treatment at these visits). Photographs will be taken at each visit and photographs from pre-treatment and follow-up 1 (week 8) will rated by blinded reviewers after the study to determine efficacy.

Conditions

• Dermatofibroma of Skin

Interventions

Type	Name	Description
DEVICE	1540 nanometer Erbium glass laser	Subjects will receive laser treatment by dermatologist at week 0 and week 4.

Timeline

• Start date: 2017-11-30
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2018-01-08
• Last updated: 2023-05-08
• Results posted: 2021-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study