Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Phase: NA
Conditions: Dermatofibroma of Skin
Sponsor: University of Utah

PI: Karen Stolman, MD 
Dermatofibroma Study 
Protocol Version 2.0 – 17MAY2018 
 
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Study Title: Efficacy of 1540nm Erbium glass laser to improve benign 
dermatofibromas 
 
 
Principal Investigator: Karen Stolman, MD 
Sponsor: University of Utah Dermatology Department 
Blinded Photography Assessors:  Michael Milliken, MD and David Smart, MD 
NCT #: 03392935 
IRB_101842 
 
 
 
Initial Protocol Version 1.0 – 17AUG2017 
Addendum Version 2.0 – 17MAY2018 (increased enrollment updated statistical plan) 
 
 
 
 
 

PI: Karen Stolman, MD 
Dermatofibroma Study 
Protocol Version 2.0 – 17MAY2018 
 
Page 2 of 5 
 
Efficacy of 1540nm Erbium glass laser to improve benign dermatofibromas 
 
BACKGROUND:  
Dermatofibromas are benign histiocytic fibrous nodules that arise in the skin, and are reported more 
often seen on the legs and in women.  These nodules can be itchy, painful and unattractive with 
discoloration or textural irregularities. 
 
Prior to use of lasers to treat dermatofibromas, dermatologists have tried to treat these nodules with 
liquid nitrogen and intralesional Kenalog injections but both these options are considered less than ideal 
and pose significant risks for worsening the lesions.  In addition, dermatofibromas can be excised, but 
excision guarantees a scar, and surgical leg wounds and scars in adult women are often compromised in 
their healing by circulation issues. 
 
There are case reports of improvement of dermatofibromas with other lasers such as the pulsed-dye 
laser and the CO2 laser (see attachments), but no clinical studies using laser treatment.  In addition, the 
non-ablative Erbium glass laser is a generally safer laser being non-ablative and is being more widely 
used in medical and cosmetic dermatology practices as it can be operated in most states (in the U.S.) by 
supervised P.A. or Aestheticians.  It would be helpful to have a treatment option that can be so widely 
used.   
 
PURPOSE & OBJECTIVES 
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 1540nm Erbium glass laser and its impact on the skin.  
  
STATISTICAL CONSIDERATIONS  
Data Analysis:  Two dermatologists will review all de-identified photos, and will rate them on a color, 
texture improvement scale as shown in the attached questionnaires. We expect to recruit about 
40 patients during the study period. Some of patients will have more than one dermatofibroma treated. 
Descriptive analyses will be performed to summarize the distribution of dermatofibroma symptoms and 
appearance at baseline. The primary analysis in this study is to test whether the laser treatment is 
significantly associated with color and texture improvement. We will use a one-sided, one-sample 
Wilcoxon signed rank test to determine whether the color and texture improvement is significant at two 
visits (i.e. visits #4 and #5) after 2 treatments. Furthermore, we will employ two-sided one-sample 
Wilcoxon signed rank test to examine the change in items in dermatofibroma symptom questionnaire 
after laser treatment. As an alternative approach, we will also employ the generalized linear mixed 
effect regression to evaluate the association between laser treatment and dermatofibroma symptom 
and appearance. All these statistical analyses will be conducted using statistical software R at the 
significant level of 0.05. We do not anticipate substantial missing data for the outcomes assessed since 
our physician will be very less likely to miss items in the survey. Even though we don’t anticipate that 
there is a substantial amount of missing data in our study, we will still compare the characteristics of 
subjects with complete versus incomplete data to assess the possibility of bias due to missing. If subjects 
with incomplete is systematically different from those with complete data, our complete-case analysis 
may be biased. We will use inverse probability weighting (IPW) approach, where complete cases are 
weighted by the inverse of their probability of being a complete case, to correct the bias induced by 
missing. 

PI: Karen Stolman, MD 
Dermatofibroma Study 
Protocol Version 2.0 – 17MAY2018 
 
Page 3 of 5 
 
 Added via Addendum (17MAY2018): We increased laser settings after the 13th patient, and therefore, 
we are now are going to increase enrollment to 40 total subjects to demonstrate effectiveness of the 
laser at the higher setting.  We also had more loss to follow-up patients than originally anticipated due 
to patients not wanting to return for follow-up visits since they were not receiving payment or 
treatment.  Since we need more subjects to complete the trial with the higher laser settings we are 
increasing enrollment to 40 subjects, and we are adding the options to have the follow-up visits done 
remotely in hopes of increasing the number of subjects that will complete all visits.   
 
STUDY DESIGN:  
This is a Prospective, interventional, Single-Blinded, open label trial.  Blinded photography outcomes 
assessors. 
 
 Added via Addendum (17MAY2018): Enrollment Goal: 40 patients 
 
PARTICIPANT ELIGIBILITY 
Inclusion criteria: 
1. 
Male or Female ages 18-65 
2. 
Must have at least one dermatofibroma of the skin, on the trunk or 
extremities, diagnosed by dermatologist 
3. 
Dermatofibroma must be either itchy, painful, or unattractive to the patient. 
Exclusion criteria: 
1. 
Previous treatment to the dermatofibroma(s) 
2. 
Pregnant or nursing women 
3. 
A diagnosis of diabetes, psoriasis, lupus or other autoimmune diseases. 
4. 
A current tobacco smoker  
5. 
A history of keloids or poor wound healing.   
6. 
Dermatofibroma lesions on the face and genitals.   
 
Recruitment: 
Participants will be recruited or identified for inclusion in the study using in-person contact, referrals, 
and written or electronic record review.  Patients who appear to be eligible for the study will be 
approached during regular clinic visits by study personnel. Electronic record review may be used to find 
possible subjects from existing patients.   
 
STUDY PROCEDURES: 
1. Screening Visit (Visit #1):  Perform Informed Consent process.  Review inclusion/exclusion criteria with 
written questionnaire, and review post-laser treatment instruction sheet. 
2.  Baseline Visit/1st of 2 Laser Treatments (Visit #2):  Sign SJHC laser treatment consent form, fill out 
dermatofibroma symptom questionnaire, take pre-treatment photos of dermatofibroma(s), perform 
first laser treatment. 
3.  Visit #3, Second Laser treatment, four weeks after first treatment.  Patient will fill out 
dermatofibroma symptom questionnaire again.  Pre-treatment photos taken of dermatofibroma(s) 
again.  Patient will sign SJHC laser treatment consent form, perform second laser treatment.   
4.  Visit #4, Four weeks follow up after second laser treatment.  Patient to fill out dermatofibroma 
symptom questionnaire, photos taken again.  This visit may be completed remotely by completing the 
questionnaire through MyChart and uploading photos of the dermatofibroma(s) through MyChart.  If 

PI: Karen Stolman, MD 
Dermatofibroma Study 
Protocol Version 2.0 – 17MAY2018 
 
Page 4 of 5 
 
subjects are experiencing any side effects or changes to their health, they should be seen in person by 
the study physician.  
5.  Visit #5, 12 weeks follow up, 16 weeks after second laser treatment.  Patient to fill out 
dermatofibroma symptom questionnaire, final photos taken.  This visit may be completed remotely by 
completing the questionnaire through MyChart and uploading photos of the dermatofibroma(s) through 
MyChart.  If subjects are experiencing any side effects or changes to their health, they should be seen in 
person by the study physician.   
 
Study Procedures 
Screening 
Visit 
(Visit 1) 
Baseline Visit 
(Visit 2 – first 
treatment) 
Visit 3 
(2nd 
Treatment) 
Visit 4 
(Follow-up 
#1) 
Visit 5 
(Follow-up 
#2) 
Week # 
 
Week 0 
Week 4 
Week 8 
Week 12 
Informed Consent 
X 
 
 
 
 
Inclusion/Exclusion 
Criteria Review 
X 
 
 
 
 
Medical History Review 
X 
 
 
 
 
Adverse Event Review 
 
X 
X 
X 
X 
Dermatofibroma 
Assessment 
X 
X 
X 
X 
X 
Questionnaires 
X 
X 
X 
X 
X 
Photographs 
 
X 
X 
X 
X 
Laser Treatment 
 
X 
X 
 
 
 
 
Data Monitoring Plan: 
- 
Research intervention is conducted in a prive place 
- 
Study will be discussed with patients individually 
- 
The collection of information about participants is limited to the amount necessary to achieve the 
aims of the research so that no unneeded information is being collected. 
- 
Research data will be stored on password protected computers  
- 
Photos of participants will be stored in the patient’s secure electronic medical record.  
- 
Periodic review and confirmation of participant elegibility, informed consent documentation and 
conformation that appropriate information has been reported to IRB will occur annually.    
- 
Independent Safety Monitor will review consent documentation, and adverse events after every 10 
patients or every 6 months (whichever comes first). 
 
 
 
 

PI: Karen Stolman, MD 
Dermatofibroma Study 
Protocol Version 2.0 – 17MAY2018 
 
Page 5 of 5 
 
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Co; 2002. 
 
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