Post Excision/Mohs Fractional CO2 Resurfacing: A Quantitative and Qualitative Scar Analysis Study
Phase: NA
Conditions: Skin Cancer
Sponsor: Icahn School of Medicine at Mount Sinai

Post Excision/Mohs Fractional CO2 Resurfacing: A Quantitative and Qualitative Scar Analysis 
Study 
PI: Hooman Khorasani, MD 
NCT02130297 
Document Date: 2/27/2019

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986 HS# 14-00132   GCO# 14-0387 
 
1 
Revised 7/20/12 
MSSM Protocol Template HRP-503a 
Instructions: 
1. Prepare a document with the following sections. Note that, depending on the nature of your research, 
certain sections below may not be applicable. Indicate N/A as appropriate, explaining where possible. 
2. For any items described in the sponsor’s protocol, grant application or other source documents 
submitted with the application, you may reference the title and page numbers of these documents rather 
than cutting and pasting into this document. Do NOT refer to any derived documents, such as the 
Sample Consent document, or other internal documents required with the submission. 
3.  If you reference page numbers, attach those pages to this protocol. 
4. When you write a protocol, keep an electronic copy. You will need to modify this copy when making 
changes. 
 
Brief Summary of Research (250-400 words): 
The purpose of this study is to evaluate the benefits and the ideal timing of treating a surgical scar 
of the skin with an ablative fractionated CO2 laser.  An attempt to quantify the amount of collagen 
that gets deposited during the healing process after being treated with the fractionated CO2 laser 
as compared to an untreated area of the scar will be performed through a spilt scar study.  Subjects 
will be placed in one of three categories, based on the timing of when their scar will receive 
intervention after the excisional surgery.  The clinical appearance of the scar will then be 
documented over several office visits and at week 16 of the scar having been treated with the CO2 
laser, a biopsy will be taken of the treated half of the scar and also one from the untreated half.  
These samples will be evaluated by confocal microscopy and H+E staining to quantify the amount 
of collagen deposition as well as the architectural changes in both the treated and untreated areas 
of the surgical scar. 
 
1) Objectives: 
The purpose of this study is to evaluate the potential benefits of treating a surgical scar 
post excision with an ablative fractionated CO2 laser with the goal of decreasing the 
appearance and size of the scar.  The hypothesis of the study is that the portion of the scar 
treated with laser will have an improved appearance and texture.  An attempt will be made 
to quantify the difference in collagen deposition and architecture with the theory being that 
the treated portion of the scar will have an architectural change similar to normal “scar-
less” tissue. A secondary objective of the study is to try and determine the ideal time to 
treat the surgical scar post-excision. 

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986 HS# 14-00132   GCO# 14-0387 
 
2 
Revised 7/20/12 
2) Background 
Improvement of scar appearance after surgery has been a concept that has been looked at for 
many years.  Katz et al. showed in the early 90’s through a split scar study that mechanicaFel 
dermabrasion improved the clinical appearance of excision scars of the skin when performed 8 
weeks after the surgery.  Recently, there has been a great interest in fractional ablative 
resurfacing to improve the appearance of scars that resulted from either trauma or burns.  
Previous studies have indicated that a noticeable clinical improvement can be achieved when 
treating these types of scars with a fractionated CO2 laser.  Fractional photothermolysis 
produces a unique thermal damage pattern known as microthermal treatment zones.  These 
zones can be characterized as multiple columns of thermal damage surrounded by areas of 
untreated tissue.  It is this intervention pattern that has revolutionized the arena of ablative 
laser therapy and enabled laser platforms such as the erbium:YAG (2,940 nm) and the carbon 
dioxide (10,600) lasers to provide effective results with significantly less side effects and 
much shorter recovery time.  A study published in the Feb. 2010 Archives of Dermatology by 
Weiss et al. looked at treating atrophic surgical and traumatic scars with ablative fractional 
resurfacing and found it to be a safe and effective intervention for improving the clinical 
appearance of scars.  It is felt that the zones of ablation and coagulation that are created 
produce dermal remodeling, tissue tightening, new collagen formation and thus lead to a 
clinical improvement in atrophic scars.  While the study by Weiss et al. attempted to quantify 
the subjective improvement of the treated scars with objective topographical skin imaging, 
there has not been an established methodology for quantitatively assessing dermal collagen 
architecture.  This pilot study will attempt to quantify the difference in collagen architecture of 
the treated area of the surgical scar compared to the untreated area by using methodology 
involving confocal microscopy established by Khorasani et al. in the Feb. 2011 article in The 
American Journal of Pathology titled  “A Quantitative Approach to Scar Analysis” 
 
3) Setting of the Human Research 
Subjects will attend their study visits in the outpatient offices at the85th street FPA clinic, 5th 
floor, Department of Dermatology 
 
4) Resources Available to Conduct the Human Research 
Meeting the recruitment goals of this project will be feasible as the surgical division of Mount 
Sinai’s Dermatology Department performs over 500 surgeries in a six month time period and 
the study is looking to recruit 45 patients, thus the study needs to recruit less then 10% of the 
patients having surgery.    
 
 
 
 
 
 
 
 
At this time there will be 2 staff members involved in this research and each member has 
already participated in IRB approved protocols at Mount Sinai and currently work at the only 

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986 HS# 14-00132   GCO# 14-0387 
 
3 
Revised 7/20/12 
study site involved in the research. All investigators have extensive experience operating the 
Lumenis Ultrapulse CO2 fractional laser.  The pathology specimens will be reviewed by a 
board certified dermatopathologist with extensive experience in evaluating specimens with 
confocal microscopy. Any additional members that will be added to assist in the study will be 
required to review the initial protocol that was submitted to the IRB and any further revisions 
required by the IRB.  The PI will ensure that all personnel that are added after initial IRB 
approval disclose any financial interests and complete their education requirements prior to 
beginning the study. 
 
5) Study Design 
a) Recruitment Methods  
Study subjects will be recruited through referrals from dermatologists at Mount Sinai’s 
Department of Dermatology Faculty Practice 
b) Inclusion and Exclusion Criteria 
      Inclusion criteria  
 
 
 
 
 
 
 
 
1. Must understand and voluntarily sign an informed consent form 2. Must be male or 
female and aged >18 years at the time of consent 3. Must be able to adhere to the study 
visit schedule and other protocol requirements 4.Patients undergoing skin excisions 
and Mohs surgery of the face/trunk/extremities  
 
 
 
 
 
 
 
Exclusion criteria  
 
 
 
 
 
 
 
 
1.Inability to provide voluntary informed consent 2.Use of laser or light based 
interventions to affected areas in past year 
3. Fitzpatrick Skin types 3-5. 4.Surgical 
lesions located on the central chest 5.History of keloid formation 6. History of 
Accutane use in the last 6 months 
 
c) Number of Subjects 
We intend to recruit and enroll 45 patients for this pilot study 
d) Study Timelines 
The duration of an individual subject’s participation in this study will be carried out over 
six months. Enrollment completion will be scheduled for April 2019. 
 
e) Study Endpoints 

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986 HS# 14-00132   GCO# 14-0387 
 
4 
Revised 7/20/12 
For primary end point refer to pg.17 , section 7.2.2.1  and for secondary end point refer to pg. 
17, section 7.2.2.2 
 
f) Procedures Involved in the Human Research 
All patients participating in this investigator initiated split-scar study will receive ablative 
fractional resurfacing with the Deep and Active FXTM platforms of the Lumenis Ultrapulse 
CO2 laser.  The settings for interventions of scars on the face with the Deep platform will 
be 15% coverage, 15mJ at 150 Hz and 15% coverage, 12.5 mJ at 150 Hz for off the face.  
The Active platform settings will be 90 mJ with a density of 3 for the face and 70 mJ and a 
density of 2 for off the face.  The DeepFXTM platform will be applied to the scar prior to 
the ActiveFXTM platform.  Half of the excision scar will be treated with the appropriate 
settings and half will go untreated.  Subjects will be randomized to receive laser 
intervention at the time of the excision, ten days post-op or 8 weeks post-op.  There will be 
a total of 15 subjects in each study group.  Each study group will consist of 5 subjects with 
excisions on the face, 5 subjects with excisions on the trunk and 5 subjects with excisions 
on the extremities.  General wound care for post surgical excision and laser therapy will 
include a topical antibiotic cream as well as a topical skin moisturizer and gauze dressing.
 
 
 
The screening visit will consist of reviewing inclusion/exclusion criteria and obtaining 
informed consent.  There will be a total of 7 study visits to include the day of the excision, 
post-op day number 10 for suture removal as well as laser therapy if the subject has been 
randomized to that intervention group, 4 weeks post-op, 9 weeks post-op and laser 
intervention for subjects randomized to this time frame for intervention, 12 weeks post-op, 
17 weeks post-op and 24 weeks post-op.  Each visit will last approximately 30-45 minutes 
each in which clinical photos of the surgical scar will be taken and any wound care or side 
effects of the laser therapy or surgery will be addressed.  Subjects will have a 3 mm punch 
biopsy taken from both the treated and untreated half of the scar at the post-op visit that 
correlates approximately with 8 weeks after having been treated with the laser (weeks 9 
for two of the subject groups and week 17 for the final study group).  These biopsy samples 
will be taken for the purpose of analyzing the ultrastructure of the collagen architecture.  
To evaluate this ultrastructure, confocal microscopy using fractional dimension and 
lacunarity analysis will be used.  Further scar analysis will be performed by H&E staining 
photographs captured on an Olympus BX51 microscope (Olympus America Inc. Center 
Valley, PA) equipped with MicroFire 2.2 digital camera (Optronics, Goleta, CA) using 
PictureFrame 2.0 software at 40X magnification.  Image analysis will then be performed 
using NIH’s shareware program, ImageJ and the Scar index will be determined.  Subjects 
will have the option of having the untreated portion of their scar treated at no charge at 
the end of the study if the subject is satisfied with the results of the study 

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986 HS# 14-00132   GCO# 14-0387 
 
5 
Revised 7/20/12 
 
g) Specimen Banking 
N/A 
h) Data Management and Confidentiality 
All records identifying the subject will be kept confidential and, to the extent permitted by 
the applicable laws and/or regulations, will not be made publicly available. Only the 
subject number will be recorded in the CRF, and if the subject name appears on any other 
document, it must be obliterated before a copy of the document is supplied to the sponsor. 
Study findings stored on a password protected computer will be encrypted and stored in 
accordance with local data protection laws.  As part of the informed consent process, the 
subjects will be informed in writing that representatives of the IRB, or regulatory 
authorities may inspect their medical records to verify the information collected, and that 
all personal information made available for inspection will be handled in strictest 
confidence and in accordance with local data protection laws.  If the results of the study 
are published, the subject’s identity will remain confidential.  Only the investigator will 
maintain a list to enable subjects to be identified.  The biopsy specimens will be sent 
directly to the dermatopathology lab as per standard operating procedure of the 
department.   The specimens will be analyzed then destroyed immediately as per hospital 
procedures for disposing biologic waste.  Photographs will be taken of the scar.  If the 
scar is present on the face, we will focus the picture in a manner that the subject’s facial 
features are not identifiable to maintain their privacy. These photographs will be labeled 
with the patient ID number and the date.  The pictures will not have any subject’s name on 
them.  They will be stored on a password protected computer until the study is over at 
which time they will be transferred onto a disc or USB drive and stored with the rest of the 
study documents. We will use the study photographs to study the effects of the laser on 
scars.  The photographs will be used for documentation of the study and for the purpose of 
being viewed by the blinded third party to evaluate the scars and rate them.  The camera 
will be stored in a locked filing cabinet in the PI’s office which has a 24 hour keypad lock.  
All photos will be deleted from the camera after being loaded on to an encrypted and 
password protected desktop computer located in the PI’s office.  Only investigators and 
co-investigators will have access to the photo files 
 
i) Provisions to Monitor the Data to Ensure the Safety of subjects 
N/A 
j) Withdrawal of Subjects 

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986 HS# 14-00132   GCO# 14-0387 
 
6 
Revised 7/20/12 
If a patient develops an infection while on the study that is serious, he or she will be 
terminated from the study. If the infection is not serious, and is mild to moderate in 
severity, then the patient and the investigator will decide, based on whether the infection 
resolves and whether it is reasonably related to study drug, whether or not to keep the 
subject on the study. Severe infections will most likely result in termination from the 
study. 
6) Risks to Subjects 
The potential risks of this study include erythema post-laser intervention. Some patients may 
be at risk for potential pigmentation loss while hyperpigmentation can also be a risk; however, 
laser settings will be adjusted according to the particular area of the body being treated.  In 
addition Fitzpatrick skin types  III-V will be excluded from the study in order to minimize this 
risk. Common minor side effects may include crusting, mild swelling, redness or brown 
discoloration at the intervention site.  In rare cases, hypertrophic scarring or infection may 
occur. The potential risks of having a biopsy include pain, local swelling, bleeding and/or 
infection.  A small scar may result at the biopsy site.  To minimize the appearance of scarring 
from the biopsy the size of the punch biopsy will be limited to 3 mm. 
 
7) Provisions for Research Related Injury 
In the event of related harm or injury the patient will be clinically evaluated by the treating 
physician.  If harm is deemed to have occurred the patient will be triaged and treated in 
clinically standard treatment protocols.  In the case of worsening scar then may consider other 
modalities (e.g. surgery with a z plasty, dermabrasion, intralesional kenalog, other lasers) or 
discoloration (other lasers to correct color or topical therapies). 
8) Potential Benefits to Subjects 
Potential benefit for the subjects will be improved cosmetic appearance of the excision scar 
that is treated with the laser.  In order to minimize any worsening of the scar appearance from 
the biopsy performed in the study, the size of the biopsy will be limited to 3 mm and will be 
taken from the center of the scar as opposed to the edge.  All subjects will be offered an 
additional intervention with the fractionated CO2 laser of the biopsy sites scars at the 
completion of the study if the subject and investigators feel the intervention will improve the 
appearance of the biopsy site 
 
9) Provisions to Protect the Privacy Interests of Subjects 
N/A.  
 
 

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986 HS# 14-00132   GCO# 14-0387 
 
7 
Revised 7/20/12 
 
 
 
 
 
MSSM Principal Monitor: 
 
Last Name: Khorasani 
First Name: Hooman 
Academic Title: Chief 
Department: Dermatology: Division of 
Mohs and Reconstructive Surgery 
 
Mailing Address: 
 
 
 
 
 New York, NY 10028 
Phone: (212) 731-3311 
Fax: (212) 987 1197 
E-mail: hooman.khorasani@ 
mountsinai.org 
 
 
 
 
MSSM Additional Monitor: 
Last Name: Lin 
 
 
First Name: Matthew 
Academic Title: Procedural Fellow 
Department: Dermatology 
 
Phone: (212) 731-3311 
Fax: (212) 731-3395 
E-mail: matthew.lin@mountsinai.org 

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986  HS# 14-00132   GCO# 14-0387 
 
8 
Revised  9/2/14 
 
2. The principal monitor is the principal investigator, and the additional monitor is 
the sub-investigator.  Please refer to respective curriculum vitae for further 
information. 
3.  Adverse events and subject compliance to the protocol will be monitored for 
safety 
 
4. Safety and accumulated adverse events will be reviewed at least quarterly. 
5.  The PI is the only entity that can amend the protocol for administrative or 
safety reasons. Any changes will be submitted to the IRB for approval prior to 
implementation.  
6. As per the protocol, the energy setting for treating scars on the trunk and 
extremity will be reduced to minimize the risk of hyperpigmentation.  In 
addition, subjects with Fitzpatrick skin types III-V will be excluded from the 
study to minimize the risk of a subject developing hyperpigmentation from the 
laser intervention. 
 
7.  N/A 
 
8.  Please see attached protocol page 18 sections 8 and 9. 
9.  Should a temporary or permanent suspension of the study occur, the 
PPHS and IRB will be contacted 
10) 
Economic Impact on Subjects 
Methods of protecting the rights and welfare of subjects include: not 
preferentially enrolling vulnerable subjects (those that are economically 
disadvantaged will not be financially induced because no compensation is 
being provided for participation in this study, providing information to 
subjects in terms that they can fully understand (the consent form is 
specifically written such that an individual with a 6th grade education can 
understand), not exerting any overt or covert coercion, not offering any 
financial incentives or if offered, not giving an amount that could be 
considered coercive, and using a consent document that the subject will be 
asked to sign that is written in the language that the potential subject 
understands. We will also make sure that the subject understands that there 
are other options for intervention available to them outside of our study. 
 
11) 
Payment to Subjects 
none 
12) 
Consent Process 

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986  HS# 14-00132   GCO# 14-0387 
 
9 
Revised  9/2/14 
Consent will be obtained prior to any study procedures and administered 
by the Principal Investigator or delegates.  The consent process will be 
performed either at the first visit to the study site (not necessarily the first 
study visit as specified in the protocol) or should the subject prefer to take 
the consent home to read at leisure, at a subsequent visit. Methods of 
protecting the rights and welfare of subjects will be taken: not 
preferentially enrolling vulnerable subjects (those that are economically 
disadvantaged will not be financially induced because they will be 
appropriately paid for time and expenses occurred). SOP HRP-090 
Informed Consent Process for Research will be followed 
13) 
Process to Document Consent in Writing 
The standard PPHS consent template will be used for this research study. 
The consent process and date that the consent is signed is documented in 
our source notes.  
14) 
Vulnerable Populations 
Indicate specifically whether you will include or exclude each of the following 
populations: 
Include 
Exclude 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
 
X 
Wards of the State (e.g. foster children) 
 
X 
Pregnant women 
 
X 
Prisoners 
 
15) 
Multi-Site Human Research (Coordinating Center) 
N/A 
16) 
Community-Based Participatory Research 
N/A 
 

 
Protocol Title: 
Post Excision/Mohs Fractional CO2 Resurfacing: 
A Quantitative and Qualitative Scar Analysis Study 
Principal Investigator 
Name/Contact Info:  
Hooman Khorasani MD 
hooman.khorasani@mountsinai.org 
Primary Contact 
Name/Contact Info 
212-731-3311 (office) 
212-731-3395 
Date Revised: 
2/27/2019 
Study Number: 
IF# 2430986  HS# 14-00132   GCO# 14-0387 
 
10 
Revised  9/2/14 
17) 
Sharing of Results with Subjects 
During participation in this study, subjects will not be able to access their 
research records. This will be done to prevent the knowledge of study results 
from affecting the reliability of the study. Subjects’ information will be 
available should an emergency arise that would require their treating 
physician to know this information to best treat them. Subjects will have 
access to their research record and any study information that is part of that 
record when the study is over or earlier, if possible. The investigator is not 
required to release to subjects research information that is not part of their 
medical record. Subjects will always have access to their own clinical medical 
records while participating in this study. 
 
18) 
IRB Review History 
Approved through 4/15/2019. Seeking continuation for one year 
19) 
Control of Drugs, Biologics, or Devices 
Ablative fractional carbon dioxide laser is stored in a combination-locked room 
accessible only by clinical trials personnel 
Note: The IDS has its own forms that must be completed and a review process 
that must be followed before the IDS representative will sign off on Appendix B 
for submission to the PPHS.