Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas

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.

Study Overview

• Status: Completed
• Conditions: Dermatofibroma of Skin
• Intervention / Treatment: Device: 1540 nanometer Erbium glass laser

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• female or male, age 18-65, have at least one dermatofibroma of the skin, on the trunk or extremities, diagnosed by dermatologist, dermatofibroma is either itchy, painful or unattractive to the patient.

Exclusion Criteria:

• previous treatment to the dermatofibroma(s), pregnant or nursing women, diabetic, smoker, psoriasis, lupus or other autoimmune diseases, patient with a clear history of keloids or poor wound healing. This study will exclude dermatofibroma lesions on the face and genitals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Subjects; All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.	Device: 1540 nanometer Erbium glass laser; Subjects will receive laser treatment by dermatologist at week 0 and week 4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.	Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.	Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).	12 Weeks
Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.	Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).	12 Weeks
Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.	Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).	12 weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Karen Stolman, MD, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Histiocytoma; Histiocytoma, Benign Fibrous
• Other Study ID Numbers: IRB_101842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No