Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT03392935
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arm: 1
• Actual Duration (Months): 40
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatofibroma of Skin	Device: 1540 nanometer Erbium glass laser	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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.
• Primary Purpose: Treatment
• Official Title: Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
• Actual Study Start Date: Nov 30, 2017
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Modified Patient and Observer Scar Assessment Scale Color Component Comparing Improvement From Baseline to Week 12. [12 weeks]

   Patient reported assessment of color, texture, itch, and pain. Each element is graded on a 1-10 scale with 1 being normal skin/no symptoms, and 10 being most significant change/most severe symptoms. Negative change in number indicate improvement.

Secondary Outcome Measures

1. Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12. [12 Weeks]

   Patient reported assessment of color, texture, itch, and pain. Each element is graded on a 1-10 scale with 1 being normal skin/no symptoms, and 10 being most significant change/most severe symptoms. Negative number indicates improvement.

2. Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12. [12 Weeks]

   Patient reported assessment of color, texture, itch, and pain. Each element is graded on a 1-10 scale with 1 being normal skin/no symptoms, and 10 being most significant change/most severe symptoms. Negative number indicates improvement.

3. Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12. [12 weeks]

   Patient reported assessment of color, texture, itch, and pain. Each element is graded on a 1-10 scale with 1 being normal skin/no symptoms, and 10 being most significant change/most severe symptoms. Negative number indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah Dermatology	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: Adrianne Evans, MD, University of Utah Dermatology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 17, 2018
• Informed Consent Form - Aug 22, 2018

More Information

Publications

None provided.

• Responsible Party: Karen Stolman, Principal Investigator, University of Utah
• ClinicalTrials.gov Identifier: NCT03392935
• Other Study ID Numbers: IRB_101842
• First Posted: Jan 8, 2018
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Histiocytoma, Benign Fibrous; Histiocytoma

Study Results

Participant Flow

Arm/Group Title	All Subjects
Arm/Group 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Period Title: Overall Study
STARTED	37
COMPLETED	35
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Overall Participants	37
Overall Lesions	46
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	37 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.8 (10.8)
Sex: Female, Male (Count of Participants)
Female	32 86.5%
Male	5 13.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	37 100%

Outcome Measures

1. Primary Outcome

Title	Modified Patient and Observer Scar Assessment Scale Color Component Comparing Improvement From Baseline to Week 12.
Description	Patient reported assessment of color, texture, itch, and pain. Each element is graded on a 1-10 scale with 1 being normal skin/no symptoms, and 10 being most significant change/most severe symptoms. Negative change in number indicate improvement.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Subjects
Arm/Group 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Measure Participants	35
Measure lesions	44
Mean (Standard Deviation) [score on a scale]	-2.33 (2.33)

2. Secondary Outcome

Title	Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.
Description	Patient reported assessment of color, texture, itch, and pain. Each element is graded on a 1-10 scale with 1 being normal skin/no symptoms, and 10 being most significant change/most severe symptoms. Negative number indicates improvement.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Subjects
Arm/Group 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Measure Participants	35
Measure lesion	44
Mean (Standard Deviation) [score on a scale]	-0.25 (1.03)

3. Secondary Outcome

Title	Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.
Description	Patient reported assessment of color, texture, itch, and pain. Each element is graded on a 1-10 scale with 1 being normal skin/no symptoms, and 10 being most significant change/most severe symptoms. Negative number indicates improvement.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Subjects
Arm/Group 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Measure Participants	35
Measure lesions	44
Mean (Standard Deviation) [score on a scale]	-2.92 (2.89)

4. Secondary Outcome

Title	Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.
Description	Patient reported assessment of color, texture, itch, and pain. Each element is graded on a 1-10 scale with 1 being normal skin/no symptoms, and 10 being most significant change/most severe symptoms. Negative number indicates improvement.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Subjects
Arm/Group 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Measure Participants	35
Measure lesions	44
Mean (Standard Deviation) [score on a scale]	0 (0.42)

Adverse Events

Time Frame	Adverse events were collected from baseline to week 12.
Arm/Group Title	All Subjects
Arm/Group 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. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
All Cause Mortality
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/37 (0%)
Serious Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/37 (0%)
Other (Not Including Serious) Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	37/37 (100%)
Skin and subcutaneous tissue disorders
Transient Erythema	37/37 (100%)	87
Transient Edema	37/37 (100%)	87

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.