Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Primary Purpose
Dermatofibroma of Skin
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1540 nanometer Erbium glass laser
Sponsored by
About this trial
This is an interventional treatment trial for Dermatofibroma of Skin
Eligibility Criteria
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.
Sites / Locations
- University of Utah Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Subjects
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03392935
Brief Title
Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Official Title
Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatofibroma of Skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will have their dermatofibromas treated with the laser at week 0, and week 4. Blinded outcome assessors will rate photos (pre-treatment and follow-up visit 1) to determine efficacy.
Masking
None (Open Label)
Masking Description
Outcome assessors are masked and will not know which photos are pre-treatment or follow-up visit 1, however, they do know that all subjects received treatment at some point. They will rate the dermatofibromas to determine efficacy. However, there is only one arm of this study. All patients are receiving the same treatment. Outcomes assessors are the only masked roles.
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
1540 nanometer Erbium glass laser
Intervention Description
Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Primary Outcome Measure Information:
Title
Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.
Description
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).
Time Frame
12 Weeks
Title
Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.
Description
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).
Time Frame
12 Weeks
Title
Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.
Description
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).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Stolman, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Dermatology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
We'll reach out to this number within 24 hrs